Illumina Sues BillionToOne Over Prenatal Testing Tech

The lawsuit, filed May 7, is Illumina’s latest patent tilt in the field of non-invasive prenatal testing.

Illumina has sued BillionToOne, alleging infringement of patents covering non-invasive prenatal testing (NIPT.)

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.