Foundation Medicine and Memorial Sloan-Kettering Cancer Center this month announced a partnership that aims to bring genomics further into the clinic and help to translate molecular information into personalized cancer treatment.
Foundation Medicine, a molecular information company on the forefront of bringing comprehensive cancer genomic analysis to routine clinical care, has provided its first product, the FoundationOne™ assay, to clinicians since June 2012. It uses next-generation sequencing (NGS) to interrogate hundreds of cancer related genes from routine tumor samples. Test results are provided in a report that aligns detected mutations with potentially relevant treatment options and clinical trials.
The company says its test, which is priced at $5,800, offers a fully informative genomic profile for solid tumors and provides a concise report to assist physicians in matching patients with the targeted drugs or clinical trials best suited for their unique cancer. The assay is currently used by more than 1,000 doctors, as well as by 15 companies developing cancer drugs.
The company has sparked considerable enthusiasm among investors. In January, Bill Gates joined a $13.5 million expansion of its Series B venture financing, along with Yuri Milner, the Russian billionaire who invested in Facebook and Zynga. Evan Jones, co-founder and former CEO of Digene, also invested, and has taken a seat on Foundation’s board.
That $13.5 million investment added onto the $42.5 million Foundation raised in its Series B round in September, bringing the total for the round to $56 million and about $100 million of total investment in the company since its 2009 founding. The investor syndicate also included Third Rock Ventures, Google Ventures, Kleiner Perkins Caufield & Byers, Roche Venture Fund, and LabCorp.
What investors see in the company’s approach to cancer genomics may be a giant step forward, one that bridges the gap between genomic information and its clinical utility by presenting in it a useful context.
“It is increasingly challenging for physicians to incorporate the latest molecular diagnostic tests to help guide treatment of cancer patients due to the growing number of molecular subtypes that are understood across tumor types,” the company says. It adds that as more targeted therapies are approved for new molecular subtypes, the number of tests that need to be performed on each patient to determine their subtype increases and very quickly exhausts the very small amount of tumor tissue that is available in routine, clinical samples.
While oncologists can access the My Cancer Genome website to try to match patient mutations with drug therapies, the barrage of information, and its interpretation can prove daunting. The site, which started two years ago and includes 51 contributors from 20 institutions, operates free of charge, and is managed by Vanderbilt-Ingram Cancer Center. It lists mutations in different types of cancer, as well as drug therapies that may or may not be of benefit. Most of the drugs are in clinical trials; a few have been approved by the Food and Drug Administration.
Oncologists agree. As William Pao, M.D., Ph.D., director of personalized cancer medicine at Vanderbilt University Medical Center, Nashville, said in an interview with The New York Times, “There are so many genes and so many mutations. The human brain can’t memorize all those permutations.”
Several tests are available that analyze tumors for single or several genetic anomalies. One test, developed by Abbott Laboratories in collaboration with Pfizer, identifies patients with a rare form of lung cancer linked to the anaplastic lymphoma kinase (ALK) gene.
Pfizer’s anticancer drug Xalkori (crizotinib) acts as an ALK and ROS1 (c-ros oncogene 1) inhibitor, and was approved for treatment of some non-small cell lung carcinomas by the FDA in just four years and based on studies in 255 patients, largely because the company could use the test to select patients most likely to benefit from the drug.
Growing information about genetics and cancer suggests that patients do not all respond to the same drugs. Still, testing patients for each and every genetic anomaly one at a time would be “very onerous, expensive, and time-consuming,” says Dr. Pao. “The nice thing about platforms like the one Foundation has is that it detects all of them at the same time.”