The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
SANTA CLARA, Calif. – Just as it does with treatments, the National Comprehensive Cancer Network (NCCN) offers detailed guidelines on genomic testing by cancer type. These are key in determining what physicians can prescribe routinely and what insurers will cover. But those guidelines aren’t followed regularly outside a major research hospital setting, thereby obviating access to tumor genetic information that could help to better guide treatment. Even if current guidelines are followed, physicians and patients can get information back from the tests that neither party is prepared to process.
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.
Two players in the gene sequencing space, Illumina Inc. and Pacific Biosciences, have scotched their planned $1.2 billion merger roughly two weeks after the U.S. Federal Trade Commission posted a 5-0 vote to seek an injunction against the merger.
Health care-associated infections (HAI) pose a constant challenge for hospitals and health systems, resulting in increased morbidity and mortality and billions in costs each year. According to the Centers for Disease Control and Prevention, about 1 in 31 patients has at least one HAI at any given time. In 2016, the U.S. Department of Health and Human Services set a 2020 goal of reducing HAIs by 50% below a 2015 baseline. To that end, Biotia Inc. plans to launch an artificial intelligence (AI)-enabled test to detect harmful bugs and antimicrobial resistance (AMR) early in the new year.
Irving, Texas-based Caris Life Sciences Inc. has launched an AI-based genomic profiling test to better characterize cases of cancer of unknown primary origin (CUP) and atypical cases and offer appropriate treatment options. Known as the MI GPS (Genomic Profiling Similarity) Score, the analysis is based on an AI analysis of a 592-gene panel of all the clinically relevant genetic biomarkers for cancer.
There have been three oncology drug approvals by the U.S. FDA over the last few years that were based solely on a genetic biomarker, rather than the location in the body where the tumor originated. But to make that tissue-agnostic approach a reality for oncology patients, detecting those genetic biomarkers will have to become increasingly easy and standardized.