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CDC Working with Assay Developers on Swine Flu MDx Tests

NEW YORK (GenomeWeb News) – Officials from the US Centers for Disease Control and Prevention are working on getting molecular diagnostic assays cleared for use on new platforms with new chemistries for identifying the influenza A H1N1 virus, according to speakers during an "influenza town hall meeting" organized by the Association of Public Health Laboratories.

The association is holding its annual meeting this week in Anchorage, AK, and conducted the session via teleconference, as many of the speakers and moderators were attending to the H1N1 flu, also commonly known as swine flu, outbreak at their own labs.

According to Dan Jernigan, deputy director of the influenza division at CDC, as of this morning there are 642 confirmed cases of H1N1 flu in 41 states, plus 845 probables in 42 states. The CDC's rRT-PCR Swine Flu Panel has been distributed to 78 qualified labs throughout all 50 states in the US, as well as labs in 130 countries, and 10 Department of Defense labs in the US.

Another CDC official said that the inventory of approved reagents for testing is being depleted quickly. The centers are now working with unnamed assay developers on getting new platforms and new chemistries cleared for use.

Some public health officials noted during the teleconference that they are being overwhelmed by the number of samples they are receiving and need access to automated, high-throughput systems, such as the Luminex multiplex platform, for initial screening efforts. As reported previously by GenomeWeb Daily News, the CDC's assay currently is running on Applied Biosystems' 7500 Fast Dx Real-Time PCR instrument and its research-use-only 7500 Real-Time PCR instrument.

In addition, some public health labs are teaming with local clinical labs that already have such high-throughput systems to help do initial screening of samples.

Many firms have come forward over the past two weeks to disclose their efforts in helping to develop assays or provide genetic information that could be used to help identify and monitor H1N1 flu cases.

Several microarray-based test providers have said that their tests could be used to help the labs testing samples, though the uncertain market potential could be an obstacle to some of them seeking CLIA waivers or other regulatory clearances for their tests, GWDN sister publication BioArray News reported this week. Among the chip manufacturers that have said they have products that can help public health labs right now are CombiMatrix, InDevr, Veredus, Ocimum, and ArrayIt. Prodesse also issued a statement earlier this week saying that its ProFlu+ Assay is being used by clinical labs to identify the currently circulating virus.

Meanwhile, other firms have issued statements touting the role their technologies are playing in helping public health bodies deal with the outbreak. For example, Blue Heron said last Friday that it delivered a synthetic DNA gene sequence of the H1N1 flu virus to the National Institutes of Health in three days.

Earlier today, Canada's National Microbiology Laboratory in Winnipeg said that it has decoded the genetic makeup of the Mexican and Canadian H1N1 flu viruses, claiming to be the world's first lab to complete this task. It said that it has submitted the sequence to GenBank.

The National Center for Biotechnology Information has a page on its website dedicated to H1N1 sequences submitted to GenBank from labs around the world.


Additional reporting for this article came from Dennis Waters at the APHL meeting in Anchorage.

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