Life Technologies Corp, Carlsbad, Calif, announced publication in the Journal of the American Medical Association (JAMA) of a study that underscores the clinical utility of the company’s early stage lung cancer test, Pervenio Lung RS.

car-LT-campusIntroduced in September 2012, the genetic test identifies patients who are at high risk for mortality following surgery, even for the earliest stage of lung cancer.

The test was initially validated through two independent, blinded retrospective studies published in the March 2012 issue of The Lancet that involved approximately 1,500 patients. The new study reports data from a subset of patients included in the larger validation studies. Specifically, it looks at those patients with “T1a, node-negative” tumors, cancers that are smaller than two centimeters in diameter and that have no detectable spread of the disease.

“We know that roughly a quarter of patients with T1a, node negative tumors will die within five years, most often with recurrent lung cancer,” said Michael Mann, MD, senior author of the study. “And yet these patients do not receive any chemotherapy following surgery because there are no guidelines for identifying which T1a patients are at high risk for mortality.”

Dr. Mann is associate professor of cardiothoracic surgery at the University of California, San Francisco and was involved in the development of the PervenioTM Lung RS test along with co-author David Jablons, MD, chief of general thoracic surgery at the University of California, San Francisco.

“By the time the disease recurrence can be detected, it is too late for therapies to be curative,” said Jablons. “We know from previous clinical trials that chemotherapy can cure metastatic lung cancer when it is treated even before it can be detected. Therefore, we need to identify the high-risk patients earlier, immediately after surgery if possible. Current published guidelines already recommend consideration of chemotherapy at that time even for stage I patients who are believed to be at the highest risk.”

Pervenio Lung RS is a genetic test that examines activity of 14 genes in tumor tissue. The current JAMA study demonstrates that the test accurately predicted mortality risk among 269 T1a, node-negative patients. The test categorized 92 patients as high risk; survival among these patients was just over 50%. In contrast, survival among patients classified by the test as low risk was nearly 85%. Further, when patients with tumors smaller than one centimeter were examined, 100% of the low-risk patients survived, as compared to just over 30% of the patients determined to be at high risk by the test.

The study, “Ability of a Prognostic Assay to Identify Patients at High Risk of Mortality Despite Small, Node-Negative Lung Tumors,” was supported by private endowments to the UCSF Thoracic Oncology Laboratory and by Pinpoint Genomics, which Life Technologies acquired in July 2012.

[Source: Life Technologies]