Prodesse

Precision Therapeutics and Med BioGene said this week that Precision has successfully completed previously announced clinical studies validating the use of LungExpress Dx with tissue preserved by RNAlater, a molecular fixative.

Gen-Probe's Prodesse ProAdeno+ assay; Myconostica's MycAssay Aspergillus test; Warnex launches Septin9 test in Canada.

It is the third Prodesse product cleared by FDA since Gen-Probe acquired the firm a little more than a year ago.

Gen-Probe's Prodesse ProFast+ flu assay; Diatherix's STD and herpes diagnostic panels; Mira Dx's PreOvar test for ovarian cancer risk; Seegene's MagicPlex Sepsis and Anyplex MDR-TB assays.

Gen-Probe said the assay is the only FDA-cleared molecular diagnostic test that can simultaneously detect seasonal A/H1, seasonal A/H3, and 2009 H1N1.

The vote of confidence is a stepping stone for the company to seek 510(k) approval for an H1N1 test on its platform; to tackle the point-of-care diagnostic market; and to further develop tests for other infectious diseases.

One study identified a variant of the 2009 H1N1 influenza virus that Gen-Probe's ProFlu+ test failed to flag as positive for influenza A, while a second study found an "unexpected" amount of mutability in the matrix gene of the virus that stymied PCR-based subtype testing via melting temperature analysis.

Roche's H1N1 kit and TaqScreen MPX Test; Prodesse's ProParaflu+ assay; Nanosphere's Verigene Respiratory Virus Nucleic Acid Test; Quest's Simplexa Influenza A H1N1 (2009) test

The ProParaflu+ assay joins a line of tests Prodesse sells for diagnosing and differentiating respiratory viruses.

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The United Nations is to consider a ban on field testing gene drives at a meeting being held next week, Technology Review reports.

The Associated Press reports that gene-edited food may soon be for sale.

The US Department of Health and Human Services is beginning a series of meetings on human fetal tissue research, Stat News reports.

In Cell this week: epigenetic change linked to glioblastomas, rare and low-frequency variants contributing to multiple sclerosis risk, and more.