An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
The firm's next-generation sequencing diagnostic test analyzes tumor samples from multiple genomic mutations that are targeted by therapies for non-small cell lung cancer.
The Fusion module is an in-lab upgrade to Hologic's Panther instrument, which enables labs to extend the testing capabilities of their existing Panther.
The China FDA has approved Vela's cell-free DNA extraction kit, which can be coupled with RT-PCR or NGS workflows for further analysis.
The firm's LeukoStrat CDx FLT3 Mutation Assay detects internal tandem duplications and tyrosine kinase domain mutations in patients with acute myeloid leukemia.
The test is approved as a companion diagnostic that can determine which advanced breast cancer patients have BRCA1/2 genetic mutations and will likely respond to Lynparza.
With the accreditation, the La Jolla, California-based molecular dermatology firm can provide its services in all 50 states and the District of Columbia.
Designed to run on the company's Sentosa real-time PCR system, the test has been approved for identifying and differentiating Zika in patients.
The PCR-based cartridge is designed to detect 21 pneumonia pathogens and 19 genetic markers of antibiotic resistance, and runs on the company's Unyvero system.
According to Gizmodo, researchers have developed a list of a million nucleic acid-like polymers that could store genetic information.
An opinion piece in the Washington Post argues that golden rice could save the sight and lives of many children.
US National Institutes of Health has issued a new draft data-sharing policy, ScienceInsider reports.
In Cell this week: analysis of immune microenvironment in hepatocellular carcinoma, proteogenomic analysis of clear cell renal cell carcinoma, and more.