view counter

First Swine Flu test nod goes to Quest Diagnostics

July 27, 2009 by MassDevice staff

New Jersey diagnostics maker wins FDA approval for its Focus Diagnostics subsidiary's H1N1 influenza virus test.

The race to be the first to get a diagnostic test for Swine Flu to market tipped to Quest Diagnostics, after the Food & Drug Administration gave emergency use authorization to one of its subsidiary's H1N1 influenza virus tests.

The Influenza A H1N1 (2009) Real Time RT-PCR test, made by Cypress, Calif.-based Quest unit Focus Diagnostics, is the first commercial lab test to win the emergency use nod from the FDA and the first to use Swine Flu RNA in nasal or throat samples to make the diagnosis, according to Quest. Turnaround time for the test is typically 24 hours, the company said.

The news is a blow to Waltham, Mass.-based Inverness Medical Innovations, London's Osmetech (which has local operations in Maynard, Mass.) and Kansas City-based Evogen Inc. All three were hoping to have their Swine Flu tests win favor from the FDA.

It's especially bitter medicine for Osmetech, which asked the FDA for emergency dispensation for its own molecular diagnostic for Swine Flu in May.

Support the news, become a MassDevice.com insider
view counter
Free Literature and Charts from Emergo Group
view counter

NEWS

Medtronic vet guides Cameron Health

Warren Watson, a 30-year Medtronic Inc. employee with family connections to founder Earl Bakken, is...

Quidel gains FDA clearance for pregnancy test

Quidel Corp. wins Food & Drug Administration 510(k) clearance for its chorionic gonadotropin-...

Ex-FDA commissioner joins board of Michigan cancer treatment firm

Ann Arbor, Mich.-based HistoSonics Inc. snags former Food & Drug Administration commissioner Dr....

FDA releases July 510(k) clearances

The Food & Drug Administration releases a list of the medical devices it granted 510(k) clearance...

Feds indict former Spectranetics execs

A federal grand jury indicts former Spectranetics CEO John Schulte, two other executives and a...

SEARCH JOBS


Search our database for the best open jobs in the medical devices industry.

keywords

job title or skills
location

city, state or zip

Jobs by MassDevice

view counter
view counter
PACIFIC BRIDGE MEDICAL (PBM) is a leading Asia medical consulting firm dedicated to assisting medical companies in Asia.
view counter
Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp