Life Technologies Corp. announced this week its acquisition of Pinpoint Genomics Inc., and the latter's early-stage non-small-cell lung cancer test that can help doctors identify those early-stage patients at high risk for progression to late-stage disease. Lung cancer is currently the leading cause of cancer deaths worldwide, claiming close to 1.5 million lives every year, Life Technologies reports.
Lung cancer is currently diagnosed and staged by a combination of tumor size, location, and the extent of spread to lymph nodes. The current standard of care for most Stage I disease is surgery followed by monitoring, otherwise known as "watchful waiting." The National Comprehensive Cancer Network recommends that both Stage II and the highest risk Stage IB patients be treated with adjuvant chemotherapy.
"Data from the Pinpoint assay will fill a gap of insufficient prognostic information, and help physicians and their early-stage patients, who face very difficult decisions regarding post-operative therapy, to make better, individualized plans," said Michael Mann, MD, an associate professor of cardiothoracic surgery at the University of California, San Francisco and a co-founder of Pinpoint Genomics. "It should therefore facilitate more-effective implementation of current guidelines."
The problem, he explains, is that conventional staging continues to group together in both stages I and II many patients who have been cured by surgery with patients who will recur and die. As a result, many Stage II patients forgo chemotherapy in the hope that they are in the former group; to date, there has been no validated method of identifying the highest-risk Stage I patients for whom chemotherapy is recommended.
"Physicians need molecular tools that accurately identify true high-risk patients," Mann says.
Life Technologies to Offer Test through CLIA-Certified Laboratory
The Pinpoint Genomics' laboratory acquired by Life Technologies is the first to market an application that has been rigorously validated in large-scale, independent studies to reliably predict the risk of death for early-stage lung-cancer patients. The test was developed in Pinpoint's CLIA-certified environment and validated through two independent, blinded retrospective studies involving approximately 1500 patients. Using formalin-fixed, paraffin-embedded tumor specimens, the quantitative PCR lab-developed test (LDT) measures expression of a proprietary 14-gene panel. Results of the blinded studies, which demonstrated the test's clinical validity and utility, were published in The Lancet.
"Since the test was developed and will be run in the Pinpoint laboratory on Life's qPCR platform, in addition to offering an LDT in the United States, we will be able to leverage our existing global installed qPCR platforms, which are currently being utilized in a significant number of clinical labs outside of this country," said Andrews. "Life Technologies intends to pursue IVD certification outside of the United States, so the test can be broadly deployed on the company's regulated platforms including the 7500 Fast Dx for qPCR."