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Pursuant to expanded guidelines announced over the weekend, New York State public health labs have been granted emergency authorization.
The agency issued guidance, effective immediately, that describe the circumstances in which it will allow labs to perform such testing.
Labs can deploy the test kit omitting the pan-SARS component, and new kits that are specific only to SARS-CoV-2 are being manufactured.
The agency said all tests for the virus must pass through its EUA process, but noted a test could be authorized under a single EUA for use in multiple labs.
FDA declined to comment on how or when it might respond to the request, which comes as reagent problems delay distribution of tests to public health labs.
The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.
LabCorp will be the exclusive provider of the test, which uses next-generation sequencing to look for actionable mutations cell-free DNA in NSCLC patients.
Quest and LabCorp recently highlighted increased compensation costs while other industry observers have seen salaries rising for specialties like molecular.
The plan piggybacks on national influenza surveillance, testing flu-negative samples using the CDC's rRT-PCR test for the novel coronavirus.
Diagnostics revenues for the fourth quarter were $1.76 billion, up 4 percent from $1.69 billion in the same quarter last year.
The Centers for Disease Control and Prevention says one of the test reagents will likely need to be remanufactured in its labs.
Following a lengthy discovery period, the lab is asking a South Carolina federal district court to find in its favor and decide that its negligence did not result in the death of Williams' son.
The agency aims to aid adoption of NGS within public health labs, which have significantly increased their use of the technology in recent years.
The company announced the launch of the new products in the US and Europe as part of a product portfolio it has named Panther Scalable Solutions.
The company expects that Blueprint's informatics capabilities in particular will improve variant interpretation and reporting across all its genetic test offerings.
The company announced Monday that it has inked a contract to become the primary supplier of products for immunoassay testing to Quest Diagnostics.
Revenues for the quarter were $1.93 billion, with the company attributing the growth to expanded access to insurer networks and good operational execution.
The company said that it experienced a breach of an internal data system used by its integrated oncology business and that it is investigating the incident.
Scheduled to go into effect next year, CMS' price transparency regulations could drive down reimbursements but also streamline billing for hospital labs.
The agency said it believes its recent focus on the issue has tamped down on genetic testing fraud, though it expects new questionable arrangements will emerge.