With the new certification in hand, the company plans to expand its business in the US through its Pennsylvania-based subsidiary, B. Braun CeGaT.
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.
A South African university has told the Wellcome Sanger Institute to return DNA samples it has from indigenous African communities, The Times reports.
The University of California, Berkeley's Rasmus Nielsen and Xinzhu Wei have retracted their CCR5 gene paper due to a technical artifact.
University of Virginia researchers are exploring a genetic risk test to gauge type 1 diabetes risk, NPR reports.
In PNAS this week: researchers compare two high-grade neuroendocrine lung cancers, height among ancient Europeans, and more.