Foundation Medicine, a molecular information company, has announced the launch of its second clinical product, FoundationOne Heme, a fully informative genomic profile for hematologic cancers (leukemia, lymphoma and myeloma), as well as many sarcomas and pediatric cancers.
The test has been developed in collaboration with Memorial Sloan-Kettering Cancer Center, and is designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer.
Foundation Medicine president and CEO Dr Michael J Pellini noted by introducing the company’s second clinical product, FoundationOne Heme, in only its second year of commercialization, the company is demonstrating its commitment to ongoing product innovation to make molecular information broadly available to the hematology and oncology communities at academic medical centers and community hospitals worldwide.
"Consistent with FoundationOne, our first clinical product for solid tumors, this new test is designed to fit within routine clinical practice and provide a physician with all of the relevant genomic information needed to make an informed treatment decision, which may include a targeted therapy or clinical trial.
"Our shared goal in developing FoundationOne Heme with Memorial-Sloan Kettering is to enable precision medicine and to advance treatment options for more patients living with cancer," Dr Pellini added.
FoundationOne Heme uses comprehensive, clinical next-generation sequencing (NGS) to assess routine cancer specimens for all genes that are currently known to be somatically altered and unambiguous drivers of oncogenesis in hematologic malignancies, as well as many sarcomas and pediatric cancers.
Utilizing NGS, FoundationOne Heme simultaneously detects all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and select gene rearrangements in 405 cancer-related genes. In addition to DNA sequencing, FoundationOne Heme employs RNA sequencing across 265 genes to capture a broad range of gene fusions, a type of alteration that is a common driver of hematologic cancers, sarcomas and pediatric cancers.
FoundationOne Heme fits easily into the clinical workflow of the ordering physician, and test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature.
New data from ten studies demonstrating the utility of FoundationOne Heme in hematologic malignancies will be presented during the 2013 American Society of Hematology Annual Meeting taking place 7 December to 10 December in New Orleans.
FoundationOne Heme was developed using technology, methods and computational algorithms developed by Foundation Medicine, combined with Memorial Sloan-Kettering’s deep and vast expertise in clinical and laboratory research into hematologic malignancies.
Over the seven-month development process, researchers from Memorial Sloan-Kettering analyzed more than 400 patient samples to demonstrate the accuracy and performance of FoundationOne Heme in validation studies.
Foundation Medicine will commercialize FoundationOne Heme in the US and internationally.