Pinpoint Genomics has published key data relating to its Pinpoint Dx Lung assay in the journal The Lancet, and has made the assay available to clinicians and patients exclusively through the company's laboratory in Mountain View, Calif.
The Pinpoint Dx Lung assay is a molecular diagnostic assay that 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, in patients with early-stage disease.
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). The assay was also based on results from the two largest independent, blinded studies to evaluate the clinical validity of a multi-gene molecular diagnostic assay for early-stage lung cancer, conducted by the Kaiser Permanente division of research—involving 433 patients—and the China Clinical Trials Consortium—a total of 1,006 patients from several leading cancer centers in China.
The Pinpoint Dx Lung 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.