Prodesse | GenomeWeb


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.


In Science this week: convergent evolution in bird hemoglobin, and more.

The Wall Street Journal speaks with patients affected by questionable test results from Theranos.

Researchers link variants in TACR3 to hot flashes during menopause, Live Science reports.

Kuwait says it will alter its law requiring citizens and visitors to provide DNA samples, New Scientist reports.