Foundation Medicine Releases New Data It Says Validates Its Genomic Cancer Test

Genomic cancer laboratory company Foundation Medicine said it has further validated the accuracy and practicality of its assays in conjunction with Memorial Sloan Kettering Cancer Center.

The company’s FoundationOne Heme assay analyzes DNA alterations in 405 cancer-related genes and sequences RNA in 265 genes to capture gene fusions that may be indicative of how a specific cancer should be treated.

The study, which will be published later this year in the journal Blood, compared the DNA/RNA testing against FoundationOne’s prior DNA test, which the company said had been widely validated. The results concordance between the two on 76 specimens was 99.4 percent. It was also compared against FISH, PCR and a test distributed by Sequenom. It achieved 99 percent concordance.

Additionally, the Heme assay detected 126 somatic alterations that could not be spotted using other assays, including changes in the KRAS, TET2, EZH2, and DNMT3A genes.

The test also detected in more than three-quarters of the specimens at least one alteration linked to a commercially available cancer therapy or one that is under development. And more than 60 percent of the cases harbored at least one alteration with a known prognostic relevance.

“Foundation Medicine has an established track record of developing genomic profiling assays with the highest standards of analytical and clinical validation,” said Vincent Miller, M.D., Foundation’s chief medical officer, in a statement. “Publication of our validation data in this highly regarded, peer-reviewed journal supports the clinical significance of the FoundationOne Heme assay ... for its ability to identify specific therapeutic targets, to help refine underlying diagnosis, and to improve prognostic and risk stratification of hematologic cancers.”

The company’s stock, which had been trading at nearly $50 a share in the spring of 2015, is now in the $17 range. Foundation said it would release its first quarter earnings report early next month.

Takeaway: Foundation Medicine has released data strongly suggesting that its genomic profiling could find avenues of care currently unknown for some cancer patients.