FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emerge

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has granted an emergency use authorization to the company's Focus Diagnostics business for its test for detecting the 2009 H1N1 influenza virus (the "pandemic flu virus"), a strain of influenza A virus initially referred to as the swine flu virus.

news.taume.com... uest-Diagnostics--Focus-Diagnostics-Business-11533

I found this press release by Quest to be enigmatic.

"This emergency use authorization means that the Influenza A H1N1 (2009) Real Time RT-PCR, when combined with clinical and epidemiological assessments, can aid physicians in diagnosing patients infected with the 2009 H1N1 influenza virus versus other influenza A virus strains," said Jon R. Cohen, M.D., senior vice president and chief medical officer, Quest Diagnostics.

...

the laboratory developed test to help offload an expected backlog of testing from public health laboratories. In the U.S., public health labs employ the CDC's rRT-PCR test, which the FDA authorized for emergency use in April 2009. Public health labs may use the CDC test to determine if certain high-risk patients who test positive for influenza A virus by commercial tests are infected with the pandemic flu virus.

Now, the CDC's test was THE only one approved for use in April 2009. Apparently, that didn't stop Quest and their wholly-owned subsidiary Focus to bring this newer test to market. And apparently they brought it to market with enough impetus to merit the FDA 'approving' it.... yet there's more .... this test is for use in "certain high-risk patients who test positive for influenza A virus by commercial tests are infected with the pandemic flu virus." Doesn't that mean that the majority of those test are already KNOWN or STRONGLY SUSPECTED to have the infection? Wouldn't that 'skew' the statistical results for those data published by Quest?

Quest Diagnostics is currently in the process of validating the test at a number of its CLIA high complexity laboratories around the U.S. capable of performing the test in compliance with the emergency use authorization. The Quest Diagnostics Focus laboratory in Cypress, CA, currently is the only laboratory performing this test.

The test has yet to be validated? I wonder what the criteria is for a lab to be 'in compliance' with the "emergency use authorization?"

The FDA's Emergency Use Authorization

The U.S. Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA, in response to requests from the CDC, has issued emergency use authorizations to make important diagnostic and therapeutic tools available to public health and medical personnel in order to identify and respond to the 2009 H1N1 influenza virus under certain circumstances.

Questions, questions... the FDA 'issues' emergency use authorization of an unvalidated test, available from a single company (who apparently are like, the whole 'show' when it comes to medical testing .., monopoly, anyone?). But then it is only for use under 'certain circumstances'.

The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. In the case of the Influenza A H1N1 (2009) Real Time RT-PCR, the FDA has only authorized its use for the duration of the declaration of emergency, which is currently set to expire on April 26, 2010, unless it is terminated, revoked sooner or renewed.

CLASSIC! "The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus." I guess that tells you what the deal is right there...

... emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met

Uh, OK, so the untested, unverified, or uncleared use is all OK as long as they have declared an emergency based on 'certain criteria.' Why do you think they wouldn't specify the criteria in the press release? Perhaps because the 'criteria' is subject to the whimsical perspective of the czars or other politically appointed opportunists.

By the way, FOCUS is a favorite vendor of the WHO and the CDC... can anyone guess why? Just curious mind you..., I figured they are all CFR buddies... or some such thing.

Just a bit of second guessing from the peanut gallery.... I'm sure they live to serve us

[edit on 29-7-2009 by Maxmars]