On October 16, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the company will present validation data for FoundationOne CDx, its comprehensive genomic profiling assay, at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC). Data demonstrated high concordance with multiple companion diagnostics and other single marker assays currently used to match targeted therapies to people with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer (Press release, Foundation Medicine, OCT 16, 2017, View Source [SID1234520940]). The availability of a comprehensive genomic profiling assay that is concordant with multiple companion diagnostics has the potential to advance personalized healthcare for all constituents by providing biopharma companies a platform for accelerated drug development and by improving efficient access to targeted therapies for patients.

FoundationOne CDx is a comprehensive genomic profiling (CGP) assay that incorporates multiple companion diagnostics in a single platform with molecular profiling of the 320+ genes known to drive cancer growth. These validation data are also included in the Premarket Approval Application (PMA) for FoundationOne CDx which is currently under review by the U.S. Food and Drug Administration (FDA) and also by the Centers for Medicare & Medicaid Services (CMS) as part of their Parallel Review program for breakthrough devices. FoundationOne CDx is not commercially available at this time.

“The landscape of targeted cancer treatments and associated companion diagnostics has grown tremendously in recent years. However, the ability to match tumor-specific molecular information to appropriate treatments is limited by single gene and hot spot panel tests that can exhaust valuable time and tissue,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “We are excited by our data that demonstrate high concordance between FoundationOne CDx and seven FDA-approved companion diagnostics. The biomarkers confirmed through clinical concordance studies collectively are indicated for use for up to 15 targeted therapies across multiple tumor types, including lung cancer. A single, comprehensive, pan-cancer profiling assay that is concordant with multiple companion diagnostic assays, has the potential to provide significant benefits to patients and physicians, and to accelerate the development of new personalized treatments.”

Results showed that FoundationOne CDx detected alterations in the EGFR, ALK, BRAF, ERBB2, KRAS and BRCA1/2 genes and demonstrated concordance with FDA-approved companion diagnostics currently used to match targeted therapies to patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer. In each of the separate studies, concordance was measured as positive percent agreement (PPA) with other FDA-approved tests.

The presentations will take place at the following times:

P2.02-052 — A clinically-validated universal companion diagnostic platform for cancer patient care, Oct 17, 9:30am-4:00pm JST, Exhibit Hall (Poster Presentation)

P3.02-061 — An ALK follow-on companion diagnostic using CGP for clinical care of patients with NSCLC, Oct 18, 9:30am-4:00pm JST, Exhibit Hall (Poster Presentation)

P3.02-062 — An EGFR follow-on companion diagnostic for clinical care of patients with NSCLC, Oct 18, 9:30am-4:00pm JST, Exhibit Hall (Poster Presentation)

Foundation Medicine and its collaborators will make a total of nine presentations at the meeting, including two oral presentations, three mini-oral presentations and four posters which support the ability of CGP to guide more informed and personalized care in lung cancer. In addition to the FoundationOne CDx concordance data, new data will also include characterization of genomic alterations which may be associated with response or resistance to certain targeted treatments or immunotherapy, such as MET amplifications or alterations in PTCH1 or STK11 genes. Together these findings provide new insights into the genomic drivers of lung cancer to guide more precise treatment and support the use of CGP in clinical care.

The IASLC 18th WCLC is being held October 15-18 in Yokohama, Japan.