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Dx Focus: Precision Therapeutics, Med BioGene LungExpress Dx; Hologic Prodesse ProGastro SSCS


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.

LungExpress Dx uses a proprietary 15-gene signature that helps gauge mortality risk of patients with early-stage non-small cell lung cancer who have undergone surgical removal of their tumor. The company developed its gene signature on Affymetrix's GeneChip platform, but now offers the test on a Taqman RT-PCR assay from Life Technologies.

RNAlater eliminates the need to flash-freeze specimens and to keep specimens frozen throughout storage and transport, a process that can be cumbersome and costly. It also eliminates the need for preserving tissue in formalin, which is known to cross-link and degrade the nucleic acids rendering them less suitable for specific downstream molecular applications.

The clinical studies were conducted using patient specimens prospectively accrued by Precision from a consortium of medical centers in the United States.

Vancouver-based Med BioGene and Pittsburgh-based Precision have an agreement to commercialize Med BioGene's test. Precision expects to begin commercializing LungExpress Dx in its CLIA-certified laboratory by the middle of this year.

The US Food and Drug Administration has cleared Hologic's Prodesse ProGastro SSCS assay, a real-time multiplex PCR assay for the qualitative detection of the most common bacterial pathogens associated with gastroenteritis.

Hologic acquired the technology with last year's acquisition of Gen-Probe. The assay qualitatively detects Salmonella, Shigella, and Campylobacter (C. jejuni and C. coli only undifferentiated) nucleic acids; and Shiga toxin 1 and toxin 2 genes.

The Prodesse assays run on Cepheid's SmartCycler II system, and can provide results in hours. By comparison, culture tests may take 48 hours or more for results, the company said.