NEW IWTD800 Dinner Workshop – Recent Advances in Prognostic Risk-of-Recurrence for Early Stage NSCLC – New Pinpoint Assay
6:00 pm
Life Technologies will discuss clinical evidence to support the launch of its Pinpoint Early-Stage NSCLC Risk of Recurrence Assay. As the leading cause of cancer deaths worldwide, lung cancer claims close to 1.5 million lives every year. Although medical research has realized impressive gains against many forms of cancer, the survival rate for lung cancer has not changed in 30 years, with nearly half of the early-stage patients not surviving beyond five years. This situation could benefit from better differential diagnosis and more efficient treatment protocols. The Pinpoint lung cancer test was validated in a CLIA-certified environment using two independent, blinded retrospective studies of approximately 1,500 patients, a significantly powered study compared to studies used to launch other proprietary diagnostic tests available in other cancer areas today. Using formalin-fixed, paraffin-embedded tumor specimens, this quantitative PCR test screens for expression using a proprietary 14-gene panel. The blinded studies demonstrated that the test reliably identifies early stage non-small cell lung cancer (NSCLC) patients at high risk for mortality following surgery. By utilizing the Pinpoint test, pathologists will be able to identify which patients have a high chance of recurrence and assist their clinical colleagues to direct more aggressive patient management. The Pinpoint gene panel was developed on a Life qPCR platform and can be transitioned from a CLIA LDT to an IVD/CE Marked kit.
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