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Cdx for 324 genes

By Katie Pfaff

Staff Writer

Foundation Medicine Inc. has struck up a partnership with Pfizer Inc. to develop and eventually market companion diagnostics (Cdx) for its comprehensive genomic profiling (CGP) assay, Foundationone Cdx. FDA-approved Foundationone Cdx provides genomic profiles and incorporates additional diagnostic information on solid tumors. The test detects alterations to EGFR, ALK, BRAF, ERBB2, KRAS, NRAS and BRCA1/2 genes.

The agreement will take effect in the first quarter of 2018, Melanie Nallicheri, chief business officer and head of biopharma, Foundation Medicine, told BioWorld MedTech. Broadly structured, the deal is expected to leverage both companies' strengths in the breadth of assays or therapeutics in order to "meet the goal to effect change in how we treat cancer." Foundation's Cdx and CGP assays as well as their analytics can assist oncologists in demystifying whether a medication regimen will be successful, identifying additional treatments that may have been missed, and suggesting clinical trials when possible.

Partners to advance cancer treatment

Partnerships also ultimately aim to lead to additional discoveries for either firm.

"The reason these partnerships are so important is because we came out of the gates covering all solid tumors, 324 genes, but adding additional companion diagnostic claims to the platform over time is very important," said Nallicheri.

Partnerships with pharmaceutical companies are intended to lead to further diagnostic tests and advancement in cancer treatment. Foundation also partners with Roche, Astrazeneca, and others, some of which have not been formally announced. Last year, Foundation also launched collaborations with the National Cancer Institute and the ECOG-ACRIN Cancer Research Group for a therapy matching study, and collaborated with the American Cancer Society of Clinical Oncology for its Targeted Agent and Profiling Utilization Registry study.

"[We are excited] about the fact that we are identifying more and more partners that are truly committed to taking an approach to developing new options for cancer patients that is really biomarker driven and includes levering the richness of the molecular and genomic information insights that we can provide that make the development so much better – to de-risk it, to accelerate it, and ultimately, hopefully to create a whole new set of highly potent options for cancer patients to combat the disease," said Nallicheri.

Foundationone Cdx won FDA approval last month and was considered one of the most wide-ranging genomic assays on the market, with its capability to detect across all four classes of mutations and alterations in the 324 genes tied to malignant solid tumors. (See BioWorld MedTech, Dec. 4, 2017.) Approval of the test platform prompted the Centers for Medicare and Medicaid Services to issue a preliminary National Coverage Determination at the time, potentially leading to claims coverage for the diagnostic test. A final decision on coverage is expected in the first quarter of the year. CMS coverage will open up to Foundation's testing that patient population as a covered care option, creating greater access to the test, said Nallicheri.

Gene markers and characteristics

Cambridge, Mass.-based Foundation Medical's Foundationone Cdx can evaluate alterations in genes known to increase cancer growth as well as illuminate biomarkers such as tumor mutational burden, microsatellite instability, and related information to help guide treatment decisions, choice of therapy, and aid in development of targeted medications. Foundationone Cdx won approval as both a CGP assay and companion diagnostic for some patients with breast, colorectal, melanoma, non-small-cell lung, and ovarian cancers who may receive treatment from 17 medications aimed at respective malignancies.

"These tumor types account for approximately 50 percent of today's Foundationone volume," said Troy Cox, CEO of Foundation Medicine, during a December conference call on CMS implication. "Medicare and Medicare Advantage patients represent approximately 40 percent of our total volume."

Analytics for clinical trials, physician guidance

Pfizer also will have access to Foundation's data analytics platform, Foundationinsights, to aid in pinpointing biomarkers and to inform design of subsequent clinical trials for targeted oncology therapies. Pfizer markets 10 oncology therapies for solid tumors or hematology cancers, as well as 17 items in development and 19 being evaluated in phase three research. Seven years of data and nearly 200,000 de-identified molecular tumor profiles are accessible in the company's analytics tool, allowing oncologists to drill down and conduct specific searches on tissue types in a particular patient group, for example.

Last June, Thermo Fischer Scientific Corp. was awarded FDA approval for its tumor screening and genetic test, Oncomine Dx target test. Oncomine Dx evaluates 23 genes tied to non-small-cell lung cancer, and helps to guide treatment with three approved therapies for the disease. Prior to that, Exact Sciences Corp. won FDA nod and CMS approval for its Cologuard stool DNA test to detect colorectal cancer. (See BioWorld MedTech, Aug. 13, 2014.)

Earlier this month, Foundation released its 2017 unaudited financial results for the fourth quarter. Total revenue at Dec. 31, 2017, was approximately $152.9 million, which represents a 31 percent increase from the previous year's period. Additionally, Foundation reported 67,375 clinical tests in 2017, an increase of 54 percent year over year. Revenue from biopharmaceuticals reached $99.7 million for the year, a jump of 27 percent compared to full year in 2016.

Published  January 18, 2018

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