Foundation Medicine and Novartis have entered a strategic collaboration allowing the development of companion diagnostic (CDx) tests for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics. The collaboration structure allows for multiple therapy programs and includes development, regulatory support and commercialization of CDx tests for inclusion on FoundationOne® CDx. FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics.
“It is imperative that we collaborate with all of the key stakeholders in oncology to accelerate patient access to personalized medicine,” said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. “Novartis shares this mission and we look forward to working with them to develop companion diagnostics across multiple therapies. This collaboration reaffirms our commitment to expedite biomarker-driven development and ultimately bring more personalized treatment options to patients.”
The agreement also allows for global expansion in ex-US markets including Japan, where in partnership with Chugai, Foundation Medicine has submitted FoundationOne CDx for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW). If approved in Japan, FoundationOne CDx would enable access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan.
About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling.
Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.
(Source: Foundation Medicine, Inc.)
Filed Under: Oncology