NEW YORK (GenomeWeb) – HTG Molecular Diagnostics said this week that it has submitted the third of four expected modules for the its Pre-Market Approval (PMA) application to the US Food and Drug Administration for the HTG EdgeSeq ALKPlus Assay. The assay is to be used as a companion diagnostic for crizotinib. The module included data from analytical performance studies and inter-lab reproducibility study data, the company noted.
Myriad Genetics announced that the Blue Cross Blue Shield Association's Center for Clinical Effectiveness, called Evidence Street, has reviewed Myriad's breast cancer recurrence test EndoPredict. Evidence Street determined that the test results in a meaningful improvement in net health outcomes for node-negative breast cancer patients, Myriad said. This review is a step toward receiving coverage for EndoPredict from health insurance providers in the Blue Cross Blue Shield affiliate network.
Exact Sciences also this week cited a positive Evidence Street review of its Cologuard colon cancer test. The review continues the firm's positive momentum in gaining coverage for Cologuard from payors across the US, Exact added.
Interpace Diagnostics, meanwhile, announced this week that it has entered into an agreement with Evidence Street to provide available evidence for the firm's molecular thyroid and pancreas tests, to support further coverage determinations among Blue Cross Blue Shield and other health plans. Interpace will work with Evidence Street to develop the best ways for the company to secure and preserve ongoing coverage for its marketed products and tests it is currently developing.
Digitalis announced this week that it has launched a $100 million fund for seed- and early-stage companies seeking to address challenges in human health. The firm is also looking to co-found new human health-focused companies. Digitalis has invested in three companies so far including Girihlet, which uses T-cell sequencing technology to enable longitudinal monitoring of the immune system, and Second Genome, which uses a computational microbiome platform for broad applications in humans, plants, and animals.
Sangamo BioSciences this week changed its corporate name to Sangamo Therapeutics in order to emphasize its focus on clinical development of genomic therapies using its platform technologies across genome editing, gene therapy, gene regulation, and cell therapy. Sangamo common stock will continue to trade on the Nasdaq under the current ticker symbol 'SGMO.'
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the GenomeWeb site.