The Pinpoint Dx Lung Assay is a multigene expression test that was developed to identify patients with a high likelihood of death within five years following surgery to remove early-stage tumors. The assay is run on surgical specimens that undergo routine handling by pathology laboratories, making it immediately available to virtually all patients, and offered through Pinpoint's (Mountain View, CA, USA) Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory.

The 14-gene expression assay uses quantitative polymerase chain reaction (PCR) and runs on formalin-fixed paraffin-embedded (FFPE) tissue samples. It was developed using specimens from 361 patients who underwent surgery at the University of California, San Francisco (UCSF; CA, USA).

Validation of the multigene assay took place at the Kaiser Permanente Division of Research (San Francisco, CA, USA) and the China Clinical Trials Consortium. It included 433 patients from northern California and 1,006 patients from several cancer centers in China, respectively.

The frequent recurrence of early stage 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.

Development and validation of the Pinpoint Dx Lung Assay were described in an early online publication on January 27, 2012, in the Lancet. The authors wrote, "The quantitative-PCR-based assay reliably identified patients with early-stage nonsquamous NSCLC at high risk for mortality after surgical resection."

Related Links:
Pinpoint Genomics
China Clinical Trials Consortium
Kaiser Permanente Division of Research