Carlsbad, CA (Scicasts) – Life Technologies has announced the acquisition of Pinpoint Genomics and its 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.
Early-Stage Lung Cancer Diagnostic Could Save Lives
"Although we've realized impressive gains against many forms of cancer, the survival rate for lung cancer hasn't changed in 30 years," said Ronnie Andrews, president of medical sciences at Life Technologies. "Half of the early-stage patients don't survive beyond five years, a situation that could benefit from more accurate prognosis and more efficient treatment protocols."
Lung cancer is currently diagnosed and staged by a combination of tumour 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 Dr. Michael Mann, 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.
"Some patients who don't need them receive highly toxic chemotherapeutic drugs, while others die without receiving potentially life-saving intervention simply because their risk of progression couldn't be predicted," said Dr. David Jablons, chief of general thoracic surgery at the University of California, San Francisco, who helped co-found Pinpoint Genomics with Dr. Mann. "Physicians need molecular tools that accurately identify true high-risk patients."
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 rigourously 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 1,500 patients. Using formalin-fixed, paraffin-embedded tumor specimens, this 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 highly-regarded medical journal, The Lancet.1
"By ordering the Pinpoint test, doctors will be able to identify which patients have a high chance of death after surgery, so they can be aggressive and treat those patients immediately for disease and save lives," said Dr. Jablons.
Treating disease early is also likely to be economical as better utilization of chemotherapy can eliminate the need for late-stage, extended therapies.
"We see an opportunity in lung cancer to change the treatment paradigm with more effective diagnostics," said Gregory T. Lucier, chairman and chief executive officer of Life Technologies. "As Life Technologies moves further into the diagnostics space, we will focus on tests that have strong clinical utility where there is a large unmet need."