The test differentiates between patients at high, intermediate or low risk of early death after surgery to remove a non-squamous, non-small cell lung cancer, the most common form of lung cancer.
The report in The Lancet describes the development of the assay based on specimens from 361 patients who underwent surgery at the University of California, San Francisco (UCSF), as well as the results of the two largest independent, blinded studies to evaluate the clinical validity of a multi-gene molecular diagnostic assay for early stage lung cancer. The two validation studies, conducted by the Kaiser Permanente Division of Research and the China Clinical Trials Consortium, involved 433 patients from northern California and 1,006 patients from several leading cancer centers in China, respectively.
The frequent recurrence of early stage non-small cell lung cancer (NSCLC) is generally due to metastatic disease that is undetected at the time of surgery to remove the tumor. Despite the high rate of recurrence, many early stage patients do not receive any additional therapy directed against this occult disease. The Pinpoint Dx Lung(TM) Assay is a multigene expression test that has been developed to identify those patients with a high likelihood of death within five years following surgery to remove early-stage tumors.
The Pinpoint Dx Lung(TM) assay is run on surgical specimens that undergo routine handling by pathology laboratories, making it immediately available to virtually all patients, and is offered through Pinpoint's Clinical Laboratory Improvement Amendment-certified laboratory in Mountain View, California. "It is the first step in our vision to bring powerful new tools to the oncology community," said David Berryman, Chief Executive Officer, Pinpoint Genomics.