Over the last two weeks, scientific misconduct sleuths have uncovered what appears to be systematic image manipulation in antibody validation data posted to the website of Thermo Fisher Scientific, the world’s largest supplier of instruments and reagents.

Sholto David, a UK-based researcher, found the first instance of doctored Western blots and others found many more.

“The images are 100 percent improperly edited,” David told Ion Genomics. “Some of the most obvious I’ve seen.”

That doesn’t mean the antibodies don’t work, he noted, but these images are often all a researcher has to go on when choosing which reagents to order. Thermo Fisher did not respond to multiple requests for comment.

Working on this story brought me back to my stint at Retraction Watch, where I reported on many retractions for image manipulation, as well as False Claims Act lawsuits.

Usually the stakes are lower — the professional currency of scientific publication — though millions of dollars in research grants can also be at play. Recently, Dana-Farber Cancer Institute settled a whistleblower lawsuit brought by David for $15 million, netting him a $2.6 million bounty. To see evidence of image manipulation at a company that did nearly $45 billion in revenue last year was a shock.

David told me he isn’t currently planning on launching a qui tam suit around this. Still, I will have to go back through my emails and try to find a legal expert to see if Thermo Fisher is at risk if somebody somewhere bought these antibodies with federal grant money.

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The week in genomics

Insilico Medicine and a new spinout from Human Longevity will codevelop AI foundation models aimed at decoding the biology of aging.

Insilico Medicine will contribute model architecture, benchmarking, training guidelines, and computational algorithms. Human Life Foundation Models will integrate those tools with Human Longevity’s de-identified multiomic and clinical datasets.

The companies said the jointly developed models are intended to support early detection of age-related diseases, predictive health risk modeling, and the discovery of therapeutics and personalized interventions.

Parse Biosciences and Bit.bio teamed up to map transcription factors contributing to cell identity, with the goal of advancing AI models for use in drug discovery and human cell manufacturing. No financial details of the partnership were disclosed.

Guardant Shares Spiked on FDA approval of Guardant Liquid CDx

Guardant Health received FDA approval for Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test that assesses a wider genomic footprint than the company’s previously approved Guardant360 CDx.

The new test integrates genomic and epigenomic profiling from a single blood draw, providing increased sensitivity for circulating tumor DNA (ctDNA) detection compared with the prior test. The seven companion diagnostic indications previously approved for Guardant360 CDx transfer to the new test under the approval.

PacBio Begins Shipping Reusable Sequencing Chips

PacBio said it has begun shipping multi-use sequencing reagents for the Revio instrument, based on the Sprq-Nx chemistry. Using these reagents, customers running more than 5,000 genomes per year can achieve a price per human genome (at 20X coverage) of less than $300, according to PacBio.

“In our beta testing, we saw consistently strong run performance,” Adam Ameur, a bioinformatician at Sweden’s Uppsala University, said in a statement. “The simple workflow, low failure rates, and substantially lower pricing with multi-use SMRT Cells make SPRQ-Nx a practical upgrade for large-scale sequencing projects.”

PacBio noted that it has also made improvements to DeepConsensus, a basecalling algorithm developed in collaboration with Google.

“The quality of genomic data is determined by the information richness of the sequencer and the refinement of the algorithms that process it,” Andrew Carroll, Product Lead for Genomics at Google Research, said in a statement. “New advances in DeepConsensus unlock even more of the exceptional quality inherent in HiFi sequencing, empowering scientists and clinicians to find new insights and resolve complex cases of rare disease.”

Natera to Build Huge Sequencing Facility

Natera said on May 21 it would build a new, dedicated sequencing facility in Texas that would give it the “largest sequencing capacity in the world.”

The expansion is driven by demand for its tests, particularly in oncology where it saw an increase in testing volume of 54 percent year over year in the first quarter of 2026.

Natera did not respond to questions about how many additional sequencing instruments it would house in the new facility.

Illumina Adds David King to Board

Illumina elected its latest slate of directors, adding David King, former CEO of Labcorp from 2007 to 2019. King “marks an important addition to Illumina’s Board as the company accelerates its clinical strategy to integrate genomics more broadly into the standard of care,” Illumina said in a statement.

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Liverpool FC bid farewell to forward Mohamed Salah and left back Andy Robertson over the weekend at the close of the English Premier League season.

Seemingly able to score at will, Salah dazzled on the right wing during Liverpool’s recent golden age. I will choose to remember him as part of the three-headed-monster of Salah, Sadio Mane, and Roberto Firmino. Salah leaves with the third-most goals scored in club history and the fourth-most goals in the history of the Premier League.

Doing his damage as an attacking defender on the other side of the field, Robertson was arguably the heart and soul of the team during his prime — a tenacious player who wasn’t afraid to wind up anybody, even Lionel Messi.

On May 17, Sholto David, a UK-based researcher and scientific misconduct sleuth, posted on social media that Thermo Fisher’s website “appears to show a fake Western blot for the validation of one of their p53 antibodies [...] This does not appear to be one of the ‘published figures,’ but their own internal data.”

His post included an image suggesting that one of the bands in the Western blot had been flipped or rotated around various axes and pasted into multiple other lanes.

As of May 27, many of the allegedly manipulated images remained on the Thermo Fisher website. The company did not respond to multiple requests for comment.

David’s post sparked others to search Thermo Fisher’s website, and they found similar patterns across multiple product lines. In total, multiple antibodies — including four p53 variants as well as Tau, Retinoblastoma protein, NLGN1, and Caspase 7 antibodies — showed evidence of image manipulation.

What implications the allegedly faked validation data could have isn’t clear. “The images are supposed to show that the antibodies bind specifically to their targets,” David said, noting that it’s possible the reagents do actually work.

“If people manipulate images they usually do that to make the data show something it doesn’t. In this case, I suppose the blots do not come out so clean? Perhaps there are some minor bands or unexpected binding in negative controls? From commentary online it seems like people have good experiences with the antibody clone that I first mentioned, I doubt it’s just totally false,” he said.

Thermo Fisher may not be alone in providing questionable data for its antibodies. “I’m working on something else [...] that absolutely will show widespread confusion/fraud related to antibodies sold by Abcam, stay tuned,” David wrote in response to a comment on LinkedIn.

Image manipulation of Western blots and other scientific data have plagued the peer-reviewed literature and federal grant applications for years. The consequences can be tangible: last year, Dana-Farber Cancer Institute settled a False Claims Act lawsuit for $15 million after David discovered image manipulation in papers and grant proposals submitted to the National Institutes of Health by researchers at the institute. As a whistleblower, David secured a $2.6 million payout.

Whether Thermo Fisher could be subject to a similar suit — say, if federal grant funding had been used to purchase these antibodies — is also unclear. For now, David said he hasn’t considered filing such a suit.

What’s certain is that his most recent sleuthing has struck a nerve, with dozens of comments and over a thousand reactions on LinkedIn alone.

“This explains the need to try 3+ antibodies and do validation by KO to get reliable data,” Kirill Bersuker, a scientist at the Google-associated company Calico Life Sciences, wrote in reply to one of David’s LinkedIn posts. “That’s thousands of dollars and days of research time.”

David speculated that without other quality indicators available “you might just choose the one with the prettiest blot on the supplier’s website. For that reason I can see why people feel pissed.”

The companies said on May 27 that they will combine Parse’s Evercode single-cell sequencing technology with Bit.bio’s opti-ox cell programming platform and its Cell Foundry. Together, they plan to test thousands of genetic variables simultaneously to establish causal links between specific genetic changes and biological outcomes.

“Cells operate on code, and by mapping how specific transcription factors dictate cell fate, we are unlocking that operating system. This collaboration doesn’t just generate data; it provides a foundational map for bit.bio to scale human-relevant models and feed predictive AI systems,” Przemek Obloj, CEO of Bit.bio, said in a statement.

Financial and other terms of the deal were not disclosed.

Bit.bio, which spun out of the University of Cambridge in 2016, has raised more than $200 million to date.

Parse, a University of Washington spinout, was recently acquired by Qiagen for $225 million in cash with additional potential milestone payments.

Insilico Medicine will contribute model architecture, benchmarking, training guidelines, and computational algorithms. HLFM will integrate those tools with Human Longevity’s de-identified multiomic and clinical datasets.

The companies said the jointly developed models are intended to support early detection of age-related diseases, predictive health risk modeling, and the discovery of therapeutics and personalized interventions.

In a statement, the partners described the deal as a “multi-million-dollar collaboration,” however, they did not provide more detail and no timeline for commercial availability of the models was disclosed.

“Human longevity and healthspan represent one of the most complex challenges in biology, “ Alex Zhavoronkov, CEO and founder of Insilico Medicine said in a statement. “By combining Insilico’s expertise in generative AI drug discovery and multimodal foundation models with HLFM’s unique datasets [...] we aim to build a next-generation AI system capable of decoding the biology of aging.”

Insilico Medicine said it has published more than 50 research papers on aging, longevity biomarkers, and related therapeutics since 2014. Insilico also said it recently formed a longevity advisory board chaired by Andrew Adams, group VP of molecular discovery at Eli Lilly.

Earlier this year, Insilico Medicine and Eli Lilly signed a development agreement with a $115 million up-front payment and could be worth up to $2.75 billion.

The Palo Alto, California-based company said on May 20 that the new test integrates genomic and epigenomic profiling from a single blood draw, providing increased sensitivity for circulating tumor DNA (ctDNA) detection compared with the prior test. The seven companion diagnostic indications previously approved for Guardant360 CDx transfer to the new test under the approval.

The test is “the largest FDA-approved liquid biopsy panel and covers a 100-fold larger genomic footprint versus the prior tissue-based G360 CDx,” Canaccord Genuity Analyst KYle Mikson wrote in a May 20 note to investors. “The approval also expands future companion diagnostic opportunities, which could drive higher-margin biopharma revenue and support broader adoption of [Guardant’s Reveal circulating tumor DNA monitoring tests] as a complementary monitoring assay. More broadly, the approval advances Guardant’s Smart Platform and multiomic strategy, while potentially supporting […] portfolio simplification.”

Since the close of the market on May 19, shares of Guardant are up 20 percent at $118.01.

Guardant360 Liquid CDx is intended to support treatment selection decisions for patients with advanced cancer. The test is already approved as a companion diagnostic for multiple therapies in non-small cell lung cancer and colorectal cancer, and is the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations, according to Guardant.

Guardant noted that its Smart Platform, a multiomic technology platform that the company said integrates genomic and epigenomic data, now underlies its full product portfolio.

“Guardant can now apply for [Medicare’s] Advanced Diagnostic Laboratory Test status for Guardant360 Liquid CDx, which comes with favorable pricing opportunities,” Guggenheim Securities Analyst Subbu Nambi added in a note to investors. “Based on management’s commentary, this is what we would expect them to pursue next.” Guardant could also sell the blood-based and tissue-based tests together as well as streamline ordering for blood-based tests, she said.

The FDA’s Signatera decision marks the first time a blood-based molecular MRD test has been cleared as a companion diagnostic (CDx.) It allows clinicians to use the test — which essentially says whether the tumor has returned following initial treatment — to guide treatment decisions such as initiating immunotherapy in positive patients and potentially deferring treatment in those who test negative.

Approval as a CDx means the test is now a prerequisite to prescribing this particular drug, but in the bigger picture for Natera, this week marks the moment that Signatera transitions from a promising lab-developed test with solid evidence behind it into a mandated, reimbursement-protected component of a standard treatment pathway. Now, the company can try to replicate this success across the other cancer types that it has designs on penetrating, including breast and ovarian, lung, and colorectal cancers.

This is a big deal for MRD testing in solid tumors, which is driven by detecting tumor DNA fragments in blood. This class of test is poised to become integral to treatment of solid tumors, which account for the majority of new cancer cases in the US.

When I was at the American Association for Cancer Research meeting last month, I attended a keynote session on the use of MRD in solid tumors that opened my eyes to the utility of these tests. I had previously considered them as a nice surveillance tool to catch recurrence. This is partly true: if your blood-based molecular signal returns, you’re extremely likely to have cancer recurrence. (This is helped by the fact that tests like Signatera are “tumor informed,” meaning they sequence a patient’s particular tumor with its particular mutations, a kind of a molecular “most wanted” poster.)

What I didn’t understand is that for many solid tumors, surgery alone is enough to drive remission in something like 50 percent of cases. Still, those 50 people get treated with toxic chemotherapy because studies show that overall survival is improved when 100 out of 100 people get that chemo. If you get an MRD test and it shows no signs of cancer, maybe your doctor is more comfortable in not prescribing that chemo.

If your tumor is going to come back, however, you may want a more aggressive treatment option provided by immunotherapy. For MIBC, that immunotherapy is now gated by Signatera. MRD testing can help predict recurrence sooner: a 2015 study in Science found that in breast cancer, MRD offered an eight-month headstart. And if you’re a pharmaceutical company trying to develop an immunotherapy and show a measurable extension of survival time, you don’t want those people who were good with just the surgery in your control group.

Investors have already caught on to this story. As noted by The Wall Street Journal’s David Wainer last week, Natera has seen its stock price quadruple in three years and is now valued more than Illumina ($28.22 billion to $21.24 billion,) even though Illumina provides the sequencing technology underlying Signatera. The CDx designation could further accelerate adoption.

Bladder cancer accounts for only 30,000 new cases in the US each year, but if it’s any indication of what’s to come with other solid tumors, MRD testing is about to explode.

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Thanks to everyone who has checked out the video from my live happy hour on Friday, May 15. I lucked out as Jason Gammack, CEO of Ansa Biotechnologies was able to jump from the audience into the livestream. I’ll be hosting more of these in the future, albeit with more advanced notice. If you’d like to volunteer to join as a guest, send me a message or an email at ahan@iongenomics.bio.

Aside from the MRD regulatory news, several funding announcements caught my attention this week.

In 2021, I wrote about a new method called RABID-seq which used a modified rabies virus to track cell-to-cell interactions in the brain. The modified virus deposited barcodes in each cell it infected, showing how cells were communicating. Now, Violet Therapeutics, a company trying to use that method to find new drug targets in neurodegenerative diseases, has raised $4.8 million.

Blank Bio, a startup founded by several associates of Bo Wang’s lab at the University of Toronto, announced a partnership with Pacific Biosciences to sequence RNA to feed its AI models and a $7.2 million seed financing round.

They’re convinced that RNA data can help them predict patient prognosis and response to treatment in cancer and they’re building models to help with patient selection in clinical trials.

It’s not immediately clear whether Wang, who developed scGPT and is a cofounder of Xaira Therapeutics, is involved in Blank Bio. Blank Bio did not immediately respond.

Avant Genomics, a University of Virginia spin-out developing automated sample preparation tools for liquid biopsy, has raised more than $3 million to advance its platform.

India’s Datar Cancer Genetics said it has received FDA clearance for CellDx-Tissue, its comprehensive genomic profiling assay for solid tumors.

And early last week the Translational Genomics Research Institute announced that Nhan Tran would join as VP of Cancer Discovery and Translation and codirect its Immunology and Microbiome Division. Tran comes to TGen from the Mayo Clinic.

Elsewhere on the Internet

Illumina CEO Jacob Thaysen quietly joined President Donald Trump on a recent visit to China, joining a host of other business leaders from US finance and technology companies, according to a report from Huanjia Zhang at GenomeWeb. Thaysen’s inclusion has not been well publicized by Illumina, which has not been able to sell new instruments in the country since being placed on a government blacklist in February 2025 and has seen revenue from the country continue to fall.

In a May 19 LinkedIn post, Thaysen said “it was a privilege to join President Trump” and suggested his participation came at the invitation of the US government.

Blank Bio also raised $7.2 million in seed financing, led by Define Ventures, Leonis Capital, Nova Threshold, Ripple Ventures, SignalFire, Y Combinator, and other investors.

“This dataset will give us a richer view of patient tumours, including splice isoforms, mutations, and expression signals, helping our models learn from a more complete picture of the transcriptome,” Blank Bio CEO and Cofounder Jonathan Hsu said in a May 19 LinkedIn post. The company’s models, trained on RNA data, could help predict a patient’s disease progression and response to treatment. “By capturing more of each patient’s biology, our goal is to help clinical teams design smaller, more efficient trials that are more likely to succeed.”

Proceeds from the seed round will fund model development, expanded collaborations with pharmaceutical and diagnostic companies, and new long-read RNA-seq dataset generation.

Founded in 2025, Blank Bio has participated in the Y Combinator startup accelerator. Its cofounders also include Philip Fradkin and Ian Shi, both of whom worked in the University of Toronto lab of Bo Wang, who developed the AI foundation model scGPT and cofounded Xaira Therapeutics. Fradkin and Shi were first authors on a paper published in April in Nature Methods on an RNA-based foundation model called “Orthrus.” Whether the company is commercializing Orthrus or if Wang is involved in Blank Bio isn’t clear; the company did not immediately respond to a request for comment.

Under their collaboration, Blank Bio will generate PacBio HiFi long-read bulk RNA sequencing data from up to 100 fresh-frozen patient tumor samples across multiple cancer indications. Sequencing will be conducted at Seattle Children’s Research Institute. Blank Bio will use the resulting data to train and evaluate its models, with a focus on RNA-level signals that may improve patient stratification, biomarker discovery, and clinical interpretation. Financial and other terms of the deal were not disclosed.

The collaboration aims to elucidate obscure isoform architecture, mutational complexity, and other features of patient-specific tumor biology that are lost in gene counts provided by existing RNA datasets.

Lifespan Vision Ventures (LVV) led the round, with participation from Dementia Discovery Fund, UTEC, Ono Venture Investment, and Mass General Brigham Ventures.

Proceeds will support activities for its lead small molecule program targeting EphB3, a receptor tyrosine kinase implicated in microglia-astrocyte signaling. The company is evaluating how how glial signaling contributes to the preservation and repair of synapses in the brain, or lack thereof.

EphB3 emerged from Violet’s proprietary CONNECT platform, which maps cell-to-cell signaling interactions in the brain to identify pathways involved in brain inflammation, neurodegeneration, and synaptic loss.

CONNECT is in turn based on RABID-seq, a method developed by researchers from the Broad Institute and Harvard Medical School that traces cell-cell interactions using modified rabies virus with a barcoding scheme that is read out with single-cell sequencing. [Editor’s note: I first covered RABID-seq in 2021 for GenomeWeb.]

The Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) will cover the test for recurrence monitoring following definitive treatment with curative intent in MIBC patients. The test will be available for clinicians to order on June 1, 2026.

The coverage marks the first CMS decision for Veracyte’s whole-genome sequencing-based TrueMRD platform and the commercial launch of the company’s first minimal residual disease offering.

In morning trading on May 18, shares of Veracyte were up 6 percent at $40.80.

“Surveillance for muscle-invasive bladder cancer relies heavily on imaging right now, which has real limitations in detecting early recurrence. A whole-genome MRD test that can help identify disease recurrence, often months before imaging, gives clinicians a powerful new tool,” Matthew Galsky, Deputy Director of the Mount Sinai Tisch Cancer Center, said in a statement. “The expanding clinical evidence behind Veracyte’s MRD platform is compelling, and Medicare coverage brings this test to patients at a pivotal time when the landscape of treatment for muscle-invasive bladder cancer is rapidly changing with the development of more effective systemic therapies and expanding bladder-sparing approaches.”

Up to half of MIBC patients experience recurrence within two years of initial treatment, and current surveillance relies primarily on imaging, which may not detect recurrence until disease has substantially progressed.

VeraCyte’s TrueMRD platform analyzes patient-specific tumor variants across the entire genome in each sample, allowing longitudinal tracking of tumor clonality and molecular evolution. Monitoring disease status can guide clinicians and patients in choosing treatment options, such as selecting more aggressive therapy if disease signal returns, or avoiding riskier treatments if the signal remains low.

Clinical evidence supporting the platform includes PAGER, a prospective study published in European Urology that evaluated more than 900 blood and tissue samples from 112 MIBC patients treated with neoadjuvant chemotherapy and radical cystectomy. The TrueMRD MIBC Test detected disease recurrence a median of 131 days earlier than imaging in that study.

The test is also being used in two ongoing trials: TOMBOLA, evaluating ctDNA-guided use of adjuvant immunotherapy with checkpoint inhibitors, and NEO-BLAST, which is investigating whether MIBC patients with no remaining cancer after neoadjuvant therapy can safely opt for active surveillance rather than immediate radical cystectomy.

Last week, the FDA approved Natera’s Signatera, also a tumor-informed MRD test, as a companion diagnostic for immunotherapy in MIBC.

“This clearance reflects the consistency, rigor and clinical orientation our scientific and quality teams have brought to the development of CellDx-Tissue platform,” Dadasaheb Akolkar, director of research and innovation at DCG, said in a statement. “We look forward to extending our transformational precision oncology solutions to cancer patients across global markets.”

The regulatory action sets the company up to pursue partnerships with clinical, academic, and biopharmaceutical organizations.

CellDx-Tissue is an in vitro diagnostic test that uses targeted next-generation sequencing of DNA and RNA extracted from FFPE tumor tissue. The assay covers 517 cancer-associated genes and is designed to detect single nucleotide variants, small insertions and deletions, ERBB2 gene amplification, and gene fusions involving ALK, RET, and ROS1. The test is performed at DCG’s CAP- and CLIA-accredited laboratory in Nashik, India.

The company has previously gained FDA Breakthrough Device Designation for its liquid biopsy platforms.

I’ll definitely be doing more of these in the future, albeit with more advanced notice.

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The approval, announced May 15, marks the first time a blood-based molecular minimal residual disease (MRD) test has been cleared as a companion diagnostic. The decision allows clinicians to use circulating tumor DNA MRD status to guide treatment decisions: initiating immunotherapy in MRD-positive patients and potentially deferring treatment in those who test negative.

The approval follows publication of the Phase III IMvigor011 trial in the New England Journal of Medicine in October 2025.

https://www.nejm.org/doi/full/10.1056/NEJMoa2511885

“Historically, we relied on imaging to tell us when cancer had returned, but that also meant millions of cancer cells were already present in the body,” Thomas Powles, principal investigator of the IMvigor011 trial and chair of the UK’s Barts Cancer Centre at St. Bartholomew’s Hospital, said in a statement. “As we saw with IMvigor011 and in several other trials, Signatera detected tumor DNA at an earlier timepoint and provided us with a significant head start to improve outcomes for patients.”

The Genentech-sponsored trial found that MIBC patients who tested positive on Signatera and received immunotherapy achieved significant improvements in disease-free survival and overall survival. MRD-negative patients who received no adjuvant therapy achieved 97 percent two-year overall survival.

How much this therapy will be prescribed, however, remains to be seen. Approximately 30,000 new MIBC cases are diagnosed annually in the U.S. and 150,000 globally. Surgery achieves long-term disease control in roughly half of patients, but identifying which patients are likely to recur has historically been difficult.

“While IMvigor011 is a practice changing trial in theory, key opinion leaders noted that the standard of care continues to evolve, and that as more patients receive neoadjuvant treatment fewer will also require adjuvant treatment after surgery,” Guggenheim Securities Analyst Subbu Nambi wrote in a May 15 note to investors. “Therefore, while [they] are positive on the IMvigor011 trial, they have been less optimistic as to how much this therapy will be used in practice.”

The news comes a week after Austin, Texas-based Natera reported first quarter revenue of $696.6 million, up 39 percent year over year from $501.8 million in Q1 2025.

Oncology testing was up more than 50 percent to 258,900 tests from 167,700 in the year ago quarter.

Natera has a growing portfolio of trials examining treatment based on MRD testing, including the DARE trial for estrogen receptor-positive, HER2-negative breast cancer and ALTAIR for colorectal cancer.

TitletownTech, Halyard Ventures, Virginia Venture Partners, CAV Angels, Global Impact Fund, and additional angel investors and family offices participated in the round. In a statement, the company said proceeds will support R&D, manufacturing, and additional hires.

“Liquid biopsy is only as reliable as its sample preparation. We’re building a platform that standardizes the preparation workflow so results are consistent and scalable, unlocking broader use in clinical settings,” Avant CEO and cofounder Rachelle Turiello said in a statement.

Charlottesville, Virginia-based Avant is commercializing the Source platform, which is designed to automate preparation of cell-free DNA (cfDNA) from blood samples ahead of liquid biopsy analysis. Liquid biopsy — a blood-based approach to detecting tumor-derived DNA — relies on extracting cfDNA before downstream testing can occur. That preparation step is currently performed manually across most labs, involving many steps; inconsistent handling can reduce cfDNA recovery and compromise the reliability of results.

The Avant Source platform is designed to collapse that workflow to two steps, while improving DNA yield and cutting processing time. The company holds exclusive IP developed at the University of Virginia.

“We invested in Avant because the future of diagnostics and personalized medicine depends on automation,” said Jill Enos, TitletownTech Managing Partner, said in a statement. “As technology advances, what labs are capable of is moving faster than the workflows supporting them. Avant is helping close that gap by bringing consistency and scalability to a step that has historically limited the field.”

Avant has also received a $305,000 Small Business Innovation Research Phase I grant from the National Science Foundation to automate bisulfite conversion for methylation analysis by sequencing.

The coverage expansion, announced May 13, is supported by clinical evidence from a study conducted with Spain’s Vall d’Hebron Institute of Oncology, which found the test can identify molecular responders and non-responders ahead of traditional radiologic imaging by tracking tumor dynamics.

“This decision validates our strategy of moving NeXT Personal into the heart of active treatment management. For the first time, Medicare patients on immunotherapy will have an ultrasensitive MRD test to help their doctors see if a treatment is working in real-time,” Personalis CEO Chris Hall said in a statement.

The company’s NeXT Personal uses whole-genome sequencing to track approximately 1,800 patient-specific mutations.

The genetic sequence also suggests that the virus is similar to those seen in previous Andes virus outbreaks, which is probably good news: it’s not “novel,” in the way SARS-CoV-2 was, and it doesn’t appear to have undergone any large mutations that could radically alter the way it spreads.

“For this particular outbreak, [having the genome] might help to improve contact tracing,” said Bas Oude Munnink, a virologist at Erasmus Medical Center in the Netherlands and a leader of the analysis. “In case we start to see additional cases, we can use the genomic information to try to link them to already known patients. But let’s hope it doesn’t spread too much further.”

How to report on this virus is something that science journalists are wrestling with. On one hand, several aspects of Andes virus make it much less likely to spark a pandemic. With COVID, one could be asymptomatic and still spread it, which doesn’t appear to be the case with Andes virus. On the other hand, there are echoes of COVID-19, plus the mortality rate of nearly 50 percent adds a different level of fear.

As Oude Munnink told me, perhaps the most concerning thing is that these viruses keep popping up.

“We are able to detect these sorts of viral threats earlier on, but it is quite worrying that you see all of these different viruses: SARS-CoV-2; we have now Mpox, which is also spreading globally; we have these incidental cases [of ANDV],” he said. “I hope this will keep on being an incident with a limited number of cases, but it does show that we have to truly take care.”

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In genomics industry news, old dogs are up to their old tricks:

Illumina has sued BillionToOne, alleging infringement of patents covering non-invasive prenatal testing (NIPT.) It’s the latest in a long line of patent spats over NIPT for Illumina.

Similarly, 10x has launched yet another spatial biology patent infringement suit, this time against Element Biosciences and its Aviti24 instrument and Teton chemistry.

Pumpkinseed, a Stanford University spinout that I first covered while at GenomeWeb announced a $20 million Series A financing. I spoke to cofounder and CEO Jen Dionne on the sidelines of SynBioBeta about their plans to go way beyond their current ability to sequence peptides 30 amino acids long.

Cellular Intelligence, another startup that I first reported on while at my old gig, secured an investment from Novo Nordisk and global rights to that company’s abandoned stem cell therapy program for Parkinson’s disease.

Even More Q1 Results

PacBio shares fell after the company reported selling fewer benchtop long-read Vega instruments than expected.

10x Genomics reported lower Q1 revenue, year over year, though excluding a one-time settlement payment in the year ago quarter meant revenue was up slightly.

Grail Q1 revenue was up 28 percent on Galleri test growth, however, investors eagerly await trial results to be presented at the upcoming American Society for Clinical Oncology (ASCO) annual meeting.

Elsewhere on the Internet

FDA Head: You Can’t Fire Me, I Quit!

FDA Commissioner Marty Makary is set to resign after indications that President Donald Trump was going to fire him, according to reporting from The Wall Street Journal.

10x Genomics, Curio Biosciences Preparing to Settle in Spatial Patent Spat

10x and Curio, now part of Takara Bio, have reached a deal to avoid a jury trial in US District Court, per GenomeWeb.

Andy

In a complaint filed May 8 in the US District Court for the District of Delaware, 10x Genomics alleged that Element’s Aviti24 multiomics technology infringes four patents licensed from Harvard University.

10x Genomics asked for a judgment that Element infringes its patents, permanent injunctions against Element, a jury trial, and damages.

Element launched Aviti24 in 2024 as an upgrade to its benchtop sequencing instrument that also offers the ability to do analysis of RNA, proteins, and cell structure.

10x Genomics offers single-cell and spatial transcriptomics technologies, including the recently launched Atera platform. It has been involved in multiple lawsuits over spatial RNA analysis, including with Illumina, NanoString Technologies (now part of Bruker), and Vizgen.

Element should have known about 10x’s IP, the company argued, because:

Both the NanoString and Vizgen cases were widely known in spatial biology. See, e.g., Andrew P. Han, 10x Genomics Sues NanoString, Vizgen Over Spatial Gene Expression Analysis Technologies, GenomeWeb, May 10, 2022.

10x also said it subpoenaed Element as part of the NanoString and Vizgen cases.

A preliminary analysis of five Hantavirus genomes from the recent cruise ship outbreak suggest that the virus is being passed from person to person, as has been documented in previous outbreaks.

On May 10, Gustavo Palacios, a microbiologist at the Icahn School of Medicine at Mount Sinai posted “Preliminary analysis of Orthohantavirus andesense virus sequences from a cruise-ship related cluster, May 2026,” to Virological.org, a discussion forum for virus evolution and epidemiology. The post represented work by dozens of researchers on four continents to sequence and analyze viral genomes collected from patients associated with the Andes virus (ANDV) outbreak on the MV Hondius cruise ship.

Variants found in the genomes and the similarities between them “support a scenario of initial zoonotic introduction followed by subsequent human‑to‑human transmission during the outbreak,” the researchers wrote.

Moreover, the sequences showed similarity to virus sequences detected in humans in ANDV hantavirus outbreaks in 1997 and 2018. Specifically, “the lack of diversity observed in the outbreak is similar to that observed during a cluster of human-to-human transmission in the Epuyén 2018 outbreak, in Argentina,” they wrote.

The genomes provide crucial details in framing a narrative of how the outbreak unfolded and could be used to validate PCR-based diagnostics, as was the case with COVID-19.

“For this particular outbreak, it might help to improve contact tracing,” said Bas Oude Munnink, a virologist at Erasmus Medical Center in the Netherlands and a leader of the analysis. “In case we start to see additional cases, we can use the genomic information to try to link them to already known patients. But let’s hope it doesn’t spread too much further.”

This analysis follows a May 8 post to Virological.org containing the complete sequence of one of the viral genomes, collected from a Swiss national who had travelled on the cruise ship.

“Preliminary analyses indicate only a relatively small degree of change from the most closely related Argentine sequences,” Damien Tully, a researcher at the London School of Hygiene & Tropical Medicine Uganda Research Unit, told the Science Media Centre about the first genome sequence posted May 8. “At present, there is no clear evidence from this single genome of major genetic shifts, unusual evolution, or reassortment.”

The index case of the virus developed fever, headache, and gastrointestinal symptoms on April 6 and died aboard the ship on April 11. On April 24, around 30 passengers left the ship, traveling to Johannesburg, South Africa and other destinations. The second case died after collapsing in the Johannesburg airport; that case and a third case both tested positive for hantavirus RNA in blood and serum samples in early May.

Clinical samples for the new study were collected, tested, and sequenced at multiple laboratories in South Africa, Senegal, Switzerland, and the Netherlands. On May 5, partial genome sequencing of the L-segment, which codes for a viral polymerase, a strain specific RT-PCR confirmed in two cases the presence of ANDV, a single-stranded RNA virus and the only hantavirus known to pass between humans.

The globehopping travelers infected by the virus presented new challenges. “Typically, when you have an outbreak, every sample and every analysis is being done by one laboratory,” Oude Munnink said. “In this case, it was really a multi-country, multi-laboratory investigation to see if we can shed some light on the hantavirus outbreak at this cruise ship.”

Working together allowed the researchers to distinguish genuine genomic variation from potential analytical artifacts. The various labs applied several different sequencing methods, including sequence-independent single-primer amplification (SISPA), metagenomics, and a capture-based enrichment approach from Twist Bioscience. They then used these library preparations with sequencing from Illumina, Element Biosciences, and Oxford Nanopore Technologies. Initially, there appeared to be more single-letter variants between the genomes, however, comparing them side-by-side resolved most inconsistencies.

The genomic data cannot exclude the possibility that more than one passenger was infected from the same source, the team noted. “Resolving this will require additional epidemiological data, including timelines and contact/exposure histories, together with environmental investigations such as rodent trapping and testing,” they wrote. They also noted that case two, the earliest case that provided a sample, had the lowest coverage and viral load may have been low. Their data and analysis have not yet been peer-reviewed, Oude Munnink added.

One outstanding question is where the spillover event happened. “We’re still trying to figure out where they exactly went and what was the most likely source of exposure to this virus,” Oude Munnink said. ANDV is primarily carried in the long-tailed pygmy mouse (Oligoryzomys longicaudatus); however, the confluence of virus, rodent, and human contact is unknown. A team of researchers based in Argentina are scrambling to answer this question, he noted.

Now that they have the viral genomes sequences, researchers will want to validate that their PCR tests are optimized to detect this strain.

“We are able to detect these sorts of viral threats earlier on, but it is quite worrying that you see all of these different viruses: SARS-CoV-2; we have now Mpox, which is also spreading globally; we have these incidental cases [of ANDV],” Oude Munnink said. “I hope this will keep on being an incident with a limited number of cases, but it does show that we have to truly take care.”

Under the terms of the agreement, announced May 11, Denmark’s Novo Nordisk will make an equity investment in Cellular Intelligence for an undisclosed amount and remains eligible for future milestones and royalties. Other financial terms were not disclosed.

The program centers on an allogeneic pluripotent stem cell-derived dopaminergic progenitor therapy that is currently enrolled in a first-in-human Phase 1/2 clinical trial. The therapy holds FDA Fast Track Designation and IND clearance for further clinical development.

The deal provides a potential path forward for the therapy after Novo Nordisk abandoned cell therapy efforts company-wide in late 2025.

https://www.fiercebiotech.com/biotech/novo-shutters-cell-therapy-unit-ending-work-potential-type-1-diabetes-cure

“Finding the right steward for the program was critical, and we are convinced that Cellular Intelligence has the capabilities needed to advance it further,” Jacob Petersen, senior VP of Global Research at Novo Nordisk, said in a statement. “The convergence of developmental biology and genomics, and the possibility of combining this with AI on a single platform, provide an exciting opportunity in medicine in general, and for the cell therapy field in particular.”

Boston-based Cellular Intelligence, formerly known as Somite Therapeutics, said it intends to use its AI platform to accelerate clinical development, manufacturing, and commercialization.

The company has licensed IP from Harvard University developed in Cofounder Allon Klein’s lab covering technology that encapsulates single cells while allowing repeated exposures to different conditions. University of Washington researcher Jay Shendure is also a cofounder. Cellular Intelligence intends to pair the capsules with AI foundation models to help it capture and decode the chemical signals that turn stem cells into other cells.

“Optimizing and scaling complex cell therapy programs to reach patients globally is exactly the challenge our AI-native platform was built to solve,” Cellular Intelligence CEO and Cofounder Micha Breakstone said in a statement.

The company added that data generated through this program will be used to further train the foundation model, with potential applications across cell therapy and regenerative medicine.

In connection with the deal, Cellular Intelligence is appointing Nuno Mendonça as Chief Medical Officer to lead the program’s clinical advancement. Mendonça, a neurologist, brings senior clinical development experience at Bial, AbbVie and Novartis Gene Therapies.

Cellular Intelligence has raised more than $60 million to date from investors including Khosla Ventures, CZI, SciFi VC, and AMD Ventures.

“We may need to consider fragmentation and then stitch them back together. but I would suspect, within the next 12 to 18 months, we should be able to have good preliminary results showing proof of concept for full length proteins,” Pumpkinseed CEO and Cofounder Jen Dionne told Ion Genomics at the 2026 SynBioBeta conference.

To help them towards that goal, the Stanford University spinout raised $20 million in Series A financing, announced earlier this week. NfX and Future Ventures co-led the round, with participation from Base4, ADVentures, and Stanford University, among other investors.

Pumpkinseed has also received a contract from the Defense Advanced Research Projects Agency (DARPA) for an undisclosed amount that will aid development of full-length protein sequencing. “They are very interested in biological threat detection, so looking at non-canonical amino acids and native proteins in various environmental samples,” Dionne said.

In addition to working on its de-novo sequencing and identification of proteins with high-throughput Raman (deSIPHR) technology, Pumpkinseed plans to expand its biopharma and biosecurity partnerships and to advance artificial intelligence models built on its data.

The company is entering a crowded field. Mass spectrometry remains the standard for protein identification but struggles with full-length sequencing of large proteins. Several companies, including Oxford Nanopore Technologies and Portal Biotech, are developing nanopore-based approaches, while others such as Quantum-Si are exploring different single-molecule methods.

Founded by researchers in Dionne’s Stanford lab, Pumpkinseed’s technology uses advanced photonics to identify biomolecules, including peptides as well as nucleic acids . It uses features embedded on standard silicon chips to detect these molecules, offering applications in research and diagnostics. The company is able to manufacture chips with 100 million sensors per square cm and currently can sequence peptides 30 amino acids long.

Dionne suggested that their sequencers could one day analyze 10 billion letters per day. So that is our 100 million sensors per square centimeter, each sequencing a 100 length residue peptide within a 24 hour period,” Dionne said.

The startup has already partnered with Genenetech to use its technology to identify immunopeptides relevant in oncology.

The Raman scattering data generated by the firm’s devices and used to identify peptide sequences “is extremely information rich, not only in terms of primary structure, but also secondary and tertiary structure in terms of binding,” Dionne noted. This data is driving several pilot programs with companies building AI models of biology.

For now, the company is focusing on getting longer peptide sequences of its tech. “By the end of the year, we can probably get to 100-length residues,” Dionne said.

In a complaint filed May 7 in the US District Court for the District of Delaware, Illumina alleged that BillionToOne’s Unity tests infringe US Patent Nos. 10,612,096 and 12,139,760 — both titled “Methods for Determining Fraction of Fetal Nucleic Acids in Maternal Samples” — and US Patent NO. and 12,435,373, titled “identification of polymorphic sequences in mixtures of genomic DNA.”

Illumina asked for a jury trial, a judgment that BillionToOne infringes its patents, and damages. The firm declined to comment further.

“We believe the claims are without merit and will vigorously defend against them,” a BillionToOne spokesperson said in an email.

Illumina offers the VeriSeq line of in vitro diagnostic kits and Verifi tests through its in-house CLIA lab. It has been involved with multiple lawsuits of NIPT intellectual property, including with Natera, Roche’s Ariosa Diagnostics (settled in 2021), and Ravgen (settled in 2023.)

BillionToOne has a market capitalization of $4.27 billion and on May 6 reported first quarter revenue of $108.4 million, an increase of 84 percent over the prior-year period.