Agena has an ongoing partnership with Guangzhou-based DaRui to develop MassArray-based diagnostics for cancer and inherited diseases for the Chinese market.
The firm expects to begin distributing shipments of its FTL3 assay from LabPMM GK, the marketing authorization holder in Japan, in late 2018.
The firm will begin selling its ThyGeNext thyroid cancer diagnostic tool to physicians in New York and Pennsylvania in combination with ThyraMir.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.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.
The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.
Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.
Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.
In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.