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Dx Focus: Life Tech Pervenio Lung RS; BD Max CRE Test; Gynecor Offers Roche Cobas HPV Test

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Life Technologies this week launched Pervenio Lung RS – a quantitative PCR-based assay for lung cancer prognosis that gauges the expression of 14 genes – through its CLIA lab in Sacramento, Calif.

The test was developed by Pinpoint Genomics, which Life Tech acquired earlier this year. The assay analyzes formalin-fixed, paraffin-embedded tumor specimens and assesses the expression of genes associated with lung cancer progression, such as KRAS, BRAF, EGFR, HER2, ALK, and p53.

Life Tech said that it plans to make Pervenio Lung RS available outside the US so the test can be "broadly deployed" on its regulated platforms, including the 7500 Fast Dx system.

Earlier this year, researchers from Pinpoint and elsewhere published data in The Lancet from two retrospective studies involving 1,500 early stage, non-squamous, non-small cell lung cancer patients, and found that Pervenio "reliably identified" those at heightened risk of death due to their disease.

Lung cancer patients have the worst mortality rates among cancer patients in that nearly half of early-stage lung cancer patients don't live beyond five years. Even after surgery to remove the tumor, lung cancer patients face a mortality rate of 25 percent to 65 percent.

Life Tech estimated the size for a molecular prognostic test for early-stage lung cancer patients to be around $120 million in the US and $500 million worldwide.


BD Diagnostics, a segment of Becton Dickinson, this week launched a research-use-only molecular test designed to rapidly detect antibiotic resistance genes found in the "superbug" known as carbapenem-resistant Enterobacteriaceae, or CRE.

CRE is associated with high mortality rates, is easily spread from patient to patient, and is resistant to nearly all antibiotics. In some cases there are no treatments that are effective against infections caused by CRE.

"Rapid identification is critical to allow proper treatment and isolation of patients to prevent its spread," BD said in a statement. The new assay, performed on the fully automated BD Max System, is designed to detect carbapenem resistance genes and produces results in just two hours. Conventional culture methods take several days to report results. BD is making the assay available, for research use only, to a limited number of infectious disease experts and researchers to gather feedback on its performance.


Gynecor, an Orlando, Fla.-based division of Bostwick Laboratories, said this week that it has installed a Roche Cobas 4800 system to perform DNA-based clinical testing.

The first test to be run on the system is the Cobas HPV test for human papillomavirus, which was recently approved for use by the US Food and Drug Administration.

Intended for women 30 and older, the test pinpoints whether they have HPV 16 or 18 – the two types that cause 70 percent of cervical cancers – along with 12 other high-risk types, to help doctors identify patients' personal risk for cervical cancer.

The Scan

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