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.