Life Technologies launched Pervenio™ Lung RS, a gene expression assay designed to help identify early-stage lung cancer patients who are at high risk of mortality following surgery. The test, acquired when Life took over Pinpoint Genomics in July, is a PCR assay that measures expression of a 14-gene panel on formalin-fixed, paraffin-embedded specimens. Life is offering the test through its CLIA laboratory in Sacramento, which was acquired through the buyout of Navigenics in July. The firm in addition plans to make Pervenio Lung RS available outside the U.S., for use on its approved platforms, including the 7500 Fast Dx for qPCR.
Life says that while patients with tumor types such as breast or colon can expect cure rates of up to 90% after surgical resection, lung cancer patients still face a 25–65% mortality rate even after successful surgery. Existing methods of lung cancer staging simply can’t identify patients who may be harboring undetected metastases, which means that many patients who are believed to be at low risk of disease recurrence will in fact progress, and by the time metastases are finally diagnosed it may be too late for successful treatment with chemotherapy or other drugs.
“Published guidelines already urge doctors to identify early stage patients at high risk of death, so that early chemotherapy can be used to reduce that risk and save lives,” comments one of the Pervenio test’s co-developers, Michael Mann, M.D., associate professor of cardiothoracic surgery at the University of California. “Better prognostic information will enable more informed decisions in the management of early-stage lung cancer. Many Stage II patients decline potentially life-saving intervention, not knowing what their true risk of death might be. Pervenio Lung RS has been documented to better identify the earliest stage, high-risk patients than the criteria current suggested by these guidelines.”
A research study that validated the test as a better predictor of mortality than current known risk factors was published in March. The test has separately undergone independent validation through a number of studies involving thousands of patients.