Thermo Fisher Scientific Inc. is working with Daiichi Sankyo Co. Ltd. to develop a companion diagnostic (CDx) to identify non-small-cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who could be eligible for the Tokyo-based company's cancer drug, Enhertu.
San Diego-based Illumina Inc. is synonymous with next-generation sequencing (NGS) equipment. But when it comes to dealmaking, the genomics giant is focused largely on software to make its results more useful, accessible and affordable. It has acquired cloud-based software startup Bluebee Holding BV in its latest move on this front.
Two players in the gene sequencing space, Illumina and Pacific Biosciences, have scotched their planned $1.2 billion merger roughly two weeks after the U.S. Federal Trade Commission (FTC) posted a 5-0 vote to seek an injunction against the merger. While Illumina is consequently liable for nearly $100 million in termination fees, it could recoup those monies under some circumstances. The $1.2 billion merger between Illumina Inc., of San Diego, and Pacific Biosciences of California Inc., was formally announced by the two companies in November 2018, but the deal faced substantial regulatory difficulty from the outset.
The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay – the first HIV-1 genotyping next-generation sequencing (NGS) assay to win an FDA nod – uses plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene in a single test.
The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.
St. Louis-based Pieriandx, a clinical genomics informatics company, reported that it has closed a $27 million series B funding round led by Atw Partners and Sjf Ventures. Pieriandx provides a software-as-a-service platform that the company says permits the practice of clinical genomics as a standard of care.
