Illumina Inc. and Merck & Co. Inc. are partnering to commercialize tests identifying genetic mutations used in the assessment of homologous recombination deficiency.

Illumina Inc. and Merck & Co. Inc. are partnering to commercialize tests identifying genetic mutations used in the assessment of homologous recombination deficiency (HRD). Patients whose tumors are HRD-positive may be eligible for targeted chemotherapy treatment by a class of precision medicines called PARP inhibitors. The companies will develop tests utilizing Illumina's Trusight Oncology 500 assay for genomic profiling, which is designed to identify 523 known and emerging tumor biomarkers.

The FDA has granted Anchordx Medical Co. Ltd.’s Urifind, an early detection test for bladder cancer, a breakthrough device designation (BTD). This marks the first BTD given to a liquid biopsy test for bladder cancer detection in China, putting it in good stead as it gears up for an IPO.

Lunit Inc. snagged a $26 million investment from precision oncology company from Guardant Health Inc., closing its series C tranche B funding round. Lunit is planning to use the funds to develop more artificial intelligence (AI) solutions and improve existing ones.

Foresight Diagnostics Inc. has developed a circulating tumor DNA (ctDNA) detection platform for detecting minimal residual disease (MRD) in B-cell lymphomas, a form of non-Hodgkin lymphoma and the most common lymphoma in the U.S., accounting for about 85% of all cases. Now, it has published data showing its phased variant enrichment detection sequencing (PhasED-Seq) nearly doubled the identification of patients with aggressive lymphoma who were not cured by standard therapy and need new treatment options.

Caris Life Sciences Inc. raised $830 million in a capital growth round led by Sixth Street Partners, the latest show of private investors’ zeal for backing precision medicine ventures. The infusion, which includes $235 million in equity financing, will be used for continued commercial expansion and to advance its liquid biopsy platform. T.R. Price Associates Inc., Silver Lake, Fidelity Management & Research Co. LLC were significant contributors in the round.

LONDON – Neogenomics Inc. reported it plans to acquire Inivata Ltd., taking up a $390 million fixed price option to purchase the liquid biopsy specialist eight months early. The option was agreed to in May 2020, when Neogenomics made a $25 million minority equity investment in Inivata and was granted the right to acquire the rest of the company by the end of 2021.

Invitae Corp. has inked a definitive agreement to acquire Genosity Inc., a genomics company with a technology platform for next-generation sequencing (NGS) assays, for approximately $200 million in cash and stock. Separately, the medical genetic testing company reported a $1.15 billion investment, led by Softbank Group subsidiary SB Management, to support ongoing growth initiatives. San Francisco-based Invitae expects the Genosity platform to accelerate the development and launch of its oncology products, including three tests that won FDA breakthrough device designation.

Pancreatic cancer is the third leading cause of cancer death in the U.S., in part because many cases aren’t diagnosed until they are advanced. Bluestar Genomics Inc. wants to change that with its epigenomics technology which can detect early pancreatic cancer from a standard blood draw by analyzing cell-free DNA in plasma. Now, the FDA has provided a bump, granting breakthrough device designation to Bluestar’s noninvasive pancreatic cancer detection test in patients with new-onset diabetes. According to the San Diego-based startup, of an estimated 60,000 patients diagnosed with pancreatic cancer in the U.S., nearly a fourth are found to have new-onset diabetes prior to receiving their cancer diagnosis.

The Federal Trade Commission (FTC) is seeking to block Illumina Inc.’s $7.1 billion purchase of Grail Inc., claiming the deal will “diminish innovation in the U.S. market” for multicancer early detection (MCED) tests, which could be used to flag dozens of tumor types when they are still treatable. Illumina has vowed to “pursue all legal options” to complete its acquisition of Grail, arguing that it does not compete with Grail and is committed to providing “unfettered access” to its NGS technology.