Life Technologies Corporation has announced the launch of Pervenio™ Lung RS. First-of-its-kind, the molecular test has been documented to reliably identify early stage lung cancer patients who are at high risk for mortality following surgery.
It also fulfills an unmet need for prognostic information to guide preventative treatment and improve disease management.
Lung cancer patients face a 25-65 percent mortality rate even after successful surgery, primarily because the disease often spreads early.
Current methods for lung cancer staging are not effective for identifying those patients who likely harbor undetected metastasis. By comparison, patients with colon or breast cancer, for example, can expect surgical cure rates of greater than 90 percent.
"Many lung cancer patients who are initially diagnosed with early stage disease are dying from recurrences without having received any early post-operative intervention," said Michael Mann, M.D., associate professor of cardiothoracic surgery at the University of California, San Francisco, who co-developed the test with David Jablons, M.D., chief of general thoracic surgery at the University of California, San Francisco.
"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," said Dr. Mann.
Dr. Mann continued, "Pervenio Lung RS has been documented to better identify the earliest stage, high-risk patients than the criteria currently suggested by these guidelines."
Accurate and Reliable Risk Stratification of Early Stage Patients for Better-Informed Decisions
Currently, early stage patients who are thought to be at low-risk are typically prescribed a course of monitoring following surgery, an approach frequently called "watchful waiting."
Disease recurs, however, in a large percentage of these patients, usually at distant sites, indicating that the patient harbored metastases that were not detected at the time of surgery.
Also, by the time disease recurs, treatment by chemotherapy or other therapies very rarely achieves long-term survival.
"Better prognostic information will enable more informed decisions in the management of early stage lung cancer," said Dr. Mann. "Many Stage II patients decline potentially life-saving intervention, not knowing what their true risk of death might be. The Pervenio test is the first to document better discrimination of high risk patients in both Stage IA and IB compared to published high-risk criteria for Stage IB alone."
Lung cancer is the leading cause of cancer deaths worldwide. Half of early stage patients do not survive beyond five years, in part because of the challenges to identify those at high-risk.
The market size for an early stage molecular test is estimated to be approximately $120 million in the United States and $500 million globally.
14-Gene qPCR Assay Validated in 1,500 Patients, Study Published in The Lancet
Developed by Pinpoint Genomics, which Life Technologies acquired in July, and based on technology licensed from the University of California, San Francisco, Pervenio™ Lung RS consists of a quantitative PCR (polymerase chain reaction) assay measuring expression of a proprietary 14-gene panel using formalin-fixed, paraffin-embedded tumor specimens.
The prognostic genes are related to known molecular lung cancer pathways, such as KRAS, BRAF, EGFR, HER2,ALK, and p53.
A research study published in The Lancet in March 2012 demonstrated the test's clinical validity as a better predictor of mortality than other known risk factors such as sex, smoking history and cell morphology.
It was also validated through two independent, blinded retrospective studies involving approximately 1,500 patients.
Independent validation was conducted by the Kaiser Permanente Division of Research in a masked cohort of 433 patients with Stage I disease, and on a cohort of 1,006 patients with Stage I-III disease from several leading Chinese cancer centers that are part of the China Clinical Trials Consortium (CCTC).
Test Service Offered Through CLIA Laboratory
Life Technologies' CLIA laboratory, obtained through the acquisition of Navigenics in July, is licensed in all 50 states and has currently validated the test in most states.
The 10,000-square-foot lab, located in Sacramento, Calif., will be utilized to develop additional proprietary laboratory-developed tests - initially focusing on oncology with plans to expand to assays that address additional disease areas.
The CLIA lab also offers a curated physician portal to help doctors interpret results of genomic tests. Additional plans include making Pervenio™ Lung RS available outside of the United States so the test can be broadly deployed on Life Technologies' regulated platforms, including the 7500 Fast Dx for qPCR.
"The speed with which our new laboratory organization was able to bring this test to market is a testimony to the organizational agility that will differentiate Life Technologies in the diagnostic space," said Ronnie Andrews, president of Medical Sciences at Life Technologies.
Andrews continued, "We are committed to providing multiple pathways for offering a menu of unique tests where we see unmet need and potential to significantly improve the management of complex diseases."