Biotech Values

[DewDiligence]

FMI’s methods questioned by Johns Hopkins:

http://www.wsj.com/articles/study-sparks-debate-on-accuracy-of-genome-tests-for-cancer-patients-1429120941

A new study has triggered a dispute over the accuracy of genomic tests that are increasingly used to match cancer patients with drugs that attack their tumors. The study, published today by researchers at Johns Hopkins Kimmel Cancer Center, suggests that such tests could lead doctors to prescribe an ineffective drug in up to half of cases. The reason: The tests, which analyze tumor DNA, typically don’t also analyze normal DNA from the same patient, a step the researchers said could eliminate false positive results.

But Foundation Medicine Inc., the most prominent provider of such tests, strongly disputes the finding, saying it has high confidence in the accuracy of the analyses it provides doctors and patients without sequencing normal DNA. …“At best, it’s naive,” [said] Philip Stephens, chief medical officer of the Cambridge, Mass.-based company. “At worst, it’s completely misleading.” He agreed that mutations present in both the tumor and germline DNA generally aren’t driving the cancer. But he said “no responsible diagnostic company would ever report out” most of the mutations the Hopkins study considers as false positives.

Dr. Stephens said Foundation Medicine uses the entire medical literature on cancer-related genetic mutations to evaluate tumor DNA results. “We fundamentally believe we can find 100% of the druggable alterations that should be reported to physicians,” he said.