Pathologists will want to understand how this innovative company is doing multi-gene analysis of patient tumors that includes information about therapeutics and clinical trials
CAMBRIDGE, MASSACHUSETTS—Next-generation gene sequencing is already changing how cancer is diagnosed and treated for a growing number of patients. Because it moves healthcare closer toward personalized medicine, this development has major implications for anatomic pathology groups and clinical laboratories.
One company in the forefront of personalized medicine is Foundation Medicine, based here in the Boston’s Route 128 biotech corridor. Last week, your Dark Daily Editor, Robert L. Michel, met with the executive team and toured the company’s CLIA-licensed medical laboratory to learn more about this company’s unique approach to clinical diagnostics.
Is Foundation Medicine More Than Just a Medical Laboratory Company?
In one important respect, Foundation Medicine is different than all the clinical laboratories that came before it, because it does not simply accept a specimen, perform a lab test, and report the results to the referring physician. Rather, its flagship products are intentionally designed to deliver ordering physicians what it calls a “pan-cancer” assessment of a patient’s tumor, such that, as the company notes: “each patient’s treatment is informed by a deep understanding of the molecular changes that contribute to their disease.”
On that point, Foundation Medicine (FM) describes itself as “a molecular information company dedicated to a transformation in cancer care, in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer.” It says it is the “first to analyze all relevant genomic alterations in cancer.”
Foundation Medicine currently offers two products. Its flagship service, launched in June 2012, is FoundationOne. The company describes this as a single “comprehensive genomic profile for all solid tumors to simultaneously detect all clinically relevant classes of genomic alterations [of the patient’s tumor] in a single assay.” The service looks at the 236 genes known to be clinically and biologically relevant in various types of cancers.
Michael Pellini, M.D. (above), is the President and CEO of Foundation Medicine of Cambridge, Massachusetts. His company is one of the nation’s first companies to offer an enriched diagnostic service to oncologists and physicians to help them better understand the genetic mutations in cancer and identify the most appropriate therapies for their individual patients. Pellini will be speaking about the pathology testing, genetic medicine, and the changing needs of oncologists at the 19th annual Executive War College on Lab and Pathology Medicine, which will take place in New Orleans on April 29-30, 2014. (Photo copyright by Foundation Medicine.)
Its newest service. FoundationOneHeme, was launched in December 2013 . This service is for human hematologic malignancies, sarcomas and pediatric cancers. It uses DNA sequencing to interrogate 405 genes and RNA sequencing to detect fusions in 265 genes.
Provides More than Just Diagnostic Information
The retail prices for FoundationOne and FoundationOneHeme are $5,800 and $7,200, respectively. Along with providing the referring physician with information about the genetic mutations found in the patient’s tissue, each service goes further. To guide the physician, each service identifies the therapies associated with those gene mutations known to have therapeutic benefit. In addition, clinical trials for which the patient would be a candidate are identified. The goal of this diagnostic service is provide useful guidance to the patient’s physician, based on the latest accepted developments in genomics, therapeutics, and clinical trials.
Since founded in 2009, Foundation Medical has posted steady growth in specimen volume and revenue. It successfully closed an initial public offering (IPO) in September 2013 and raised $106 million. Its stock symbol is FMI and trades on NASDAQ. Revenue for 2013 was $29 million and the company says that 2,100 physicians in 25 countries have ordered FoundationOne since its introduction in June 2012.
Time of Change for Anatomic Pathology Profession
At a time when the anatomic pathology profession must respond to the changes in the American healthcare system, companies like Foundation Medicine provide examples of how innovators believe they can deliver a different type of diagnostic service that has value for physicians, payers, and patients. This is particularly true of any type of diagnostic testing services that utilize gene sequencing and molecular diagnostics. The explosion of knowledge in genetic medicine will challenge pathologists to stay current themselves in order to better serve their client physicians.
For these reasons, pathologists, medical laboratory executives, and Wall Street investors focused on genetic medicine and clinical diagnostics will be interested to learn that they can hear Foundation Medicine’s President and CEO, Michael Pellini, M.D., speak at the upcoming 19th annual Executive War College, to take place on April 29-30, 2014 at the Sheraton Hotel in New Orleans. See the full agenda and register with this link: www.executivewarcollege.com/register.
Your Dark Daily Editor,
Robert L. Michel
Related Information:
Greenville Launches Rare Tumor Center, Nabs $1M and Partnership with Foundation Medicine
Foundation Medicine CEO sees no competition in cancer gene test market
