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The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from the BD SARS-CoV-2 test.
The firm said in an SEC document that it received an FDA warning letter in connection with the agency's requirements for its Verigene SP instrument.
The firm received a notice from Nasdaq on Oct. 4 saying its stock had not met the minimum $1-per-share closing price requirement for 30 consecutive business days.
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.
Filter tips for use with QiaSymphony SP/AS instruments may leak, which could lead to delayed or inaccurate results and cause serious injury or death.
How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The firm's life science segment grew revenues 8 percent, but revenues from its diagnostics segment saw revenues retreated 4 percent.
DNA4Life's product is marketed to patients to predict how they will respond to more than 120 of the most commonly prescribed medications.
The letter informed the firm that its production of Xpert Norovirus assays at the Solna, Sweden site does not conform to good manufacturing practice requirements.
Two COVID-19 vaccine developers have released their trial protocols to build public trust, the New York Times reports.
A new analysis finds the rapid COVID-19 test from DnaNudge to be highly accurate, Reuters reports.
In Science this week: global citizens' assembly on genome-editing technologies proposed, epigenetic markers predict metformin response, and more.
According to the Verge, many US states are not including positive results from rapid COVID-19 testing in their case numbers.