Foundation Medicine Announces First Genomic Profile for Patient Treatment
By Bio-IT World Staff
May 30, 2012 | Foundation Medicine has announced the commercial launch of FoundationOne, the first pan-cancer, fully informative genomic profile designed to help oncologists expand their patients’ treatment options.
“The care of oncology patients is on the verge of being
individualized,” CEO Michael Pellini told Bio-IT
World’s Kevin Davies earlier this year (see, “Laying
the Foundation for Next-Gen Cancer Diagnostics”). “The molecular make-up of
each tumor is going to drive personalized medicine. Our goal is to work with
oncologists and pathologists and do nothing short of transform cancer care. We
want to change the way cancer patients are managed, not just in academic
medical centers but in communities across the U.S. and internationally.”
FoundationOne is a laboratory-developed test performed at Foundation Medicine’s CLIA-certified facility and is currently available for all solid tumor types. The test is optimized to fit current oncology practice, making use of as little as 50ng of DNA from routine, formalin-fixed, paraffin-embedded tumor samples. Using next-generation sequencing, FoundationOne interrogates all genes somatically altered in human cancers that are validated targets for therapy or drivers of oncogenesis based on current knowledge. It reveals all classes of genomic alterations including base substitutions, insertions, deletions, copy number alterations and select rearrangements. Each patient’s genomic profile is reported to the physician matched with targeted therapies and clinical trials that may be relevant based on the molecular blueprint of their tumor.
“This first commercial product from Foundation Medicine is the result of a convergence of genomic sequencing, information technology, and clinical practice that would not have been possible at any other point in history,” said Pellini in a press release this morning. “Foundation Medicine is the first company with the ability to put these advances into everyday care, giving oncologists the molecular blueprint of each patient's cancer to help inform a more targeted treatment strategy.”
Early clinical studies with FoundationOne have demonstrated high accuracy and an ability to interrogate all classes of potentially actionable alterations to reveal clinically-relevant information. Since receiving CLIA certification in October, 2011 and beginning pre-launch operations, Foundation Medicine has shown that FoundationOne reveals, on average, approximately three reportable alterations per patient sample and three times as many actionable alterations than the most comprehensive “hot spot” panels or tests currently available.
“FoundationOne brings a best-in-class molecular diagnostic to all oncologists and pathologists, both in the community where most patients are treated and at major academic centers,” said Vincent Miller, senior vice president of clinical development. “FoundationOne gives physicians a powerful new tool to help them incorporate the latest genomic findings into treatment decisions for each patient.”
FoundationOne sequences hundreds of genes known to be clinically relevant in cancer and identifies any actionable alterations, whereas existing technologies are able to find only pre-determined alterations. Experience to-date shows that FoundationOne can identify previously undetectable, yet potentially actionable, alterations, and suggests that FoundationOne will profoundly increase the application of molecular information in clinical practice.
Further Reading:
Yelensky, R., et al. (April 2012) Massively parallel sequencing of clinical FFPE cancer specimens enables comprehensive genomic assessment of patient eligibility for targeted therapy. April 2012. Oral presentation at American Association for Cancer Research Annual Meeting.