Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.
The company has achieved even higher specificity than earlier data demonstrated, and is now building up its sales and marketing infrastructure for the planned launch of its lung cancer test.
The Pinnacle assay for gene fusions and gene expression in tumor samples is the first in Cofactor's new line of clinical RNA-sequencing assays.
The firm said that achieving certification is an important step toward the commercial launch of a lung cancer test later this year.
The firm said that its test is the first on the market to detect RSV infection at the point of care in 13 minutes or less.
The certification creates a path to market for Mitra's CANScript test, which replicates a cancer patient's tumor microenvironment and predicts treatment outcomes.
In a letter to congressional leaders, the groups said they "believe strongly" that the FDA should play a critical role in developing a modernized framework.
The annual list includes guidelines that would clarify regulations for garnering premarket approval or clearance of devices and diagnostics, particularly next-generation sequencing tests.
The lab was opened earlier this year as the company's central genomics lab in North America, offering various genomic services such as DNA sequencing.
The certification ensures that the biobank has the authority to handle and test human samples for the Cancer MoonShot 2020 initiative.
NPR reports that many USDA researchers working at the two agencies that are relocating to the Kansas City area are declining to go.
Genetic genealogy has helped exonerate a man who has been jailed for 20 years, Agence France Presse reports.
A new report says genetically modified food might be necessary to be able to feed a planet of nearly 10 billion people, Bloomberg says.
In Nature this week: new RNA editing approach called LEAPER, draft assembly of Musa balbisiana banana genome, and more.