MEDICAL
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Focus Diagnostics, continued ...
The FDA announced it had granted emergency-use authorization ("EUA") to
the Focus Diagnostics test on July 24. This is the first granted to a
commercial test for detecting the 2009 H1N1 influenza virus. The FDA
informed Focus Diagnostics that it had issued an amended EUA for the
company's test to reflect labeling clarifications regarding the
contents of the test kit on Aug. 17.
In April 2009, the FDA
granted two EUAs in connection with the CDC's RT-PCR diagnostic panel
used by public health labs in the U.S. to detect the 2009 H1N1
influenza virus infection. In its application to the FDA, Focus
Diagnostics presented data involving more than 100 clinical specimens
indicating that the Focus Diagnostics test agreed 100 percent with the
CDC's RT-PCR test in identifying specimens as positive or negative for
the pandemic virus.
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Focus Diagnostics, continued ...
The FDA announced it had granted emergency-use authorization ("EUA") to
the Focus Diagnostics test on July 24. This is the first granted to a
commercial test for detecting the 2009 H1N1 influenza virus. The FDA
informed Focus Diagnostics that it had issued an amended EUA for the
company's test to reflect labeling clarifications regarding the
contents of the test kit on Aug. 17.In April 2009, the FDA granted two EUAs in connection with the CDC's RT-PCR diagnostic panel used by public health labs in the U.S. to detect the 2009 H1N1 influenza virus infection. In its application to the FDA, Focus Diagnostics presented data involving more than 100 clinical specimens indicating that the Focus Diagnostics test agreed 100 percent with the CDC's RT-PCR test in identifying specimens as positive or negative for the pandemic virus.
<< PREVIOUS PAGE
Related headlines
Irvine's Access OC implements electronic consultation service
UC Irvine chemistry center nets $20 million grant
Seal Beach-based DTS garners U.S. Air Force grant
Waypharm USA launches in Laguna Beach
Aliso Viejo's Avanir announces positive study results
