Novartis tasks Foundation with companion diagnostic development for cancer treatments

test tubes
The latest agreement follows development deals with Merck, Pfizer and Roche's Chugai, which aims to secure Japanese approval for Foundation's pan-cancer assay. (Pixabay)

Novartis has tapped Foundation Medicine to develop companion diagnostic tests for its cancer treatment portfolio, including multiple precision drugs and immunotherapies.

The collaboration includes development and regulatory support, as well as the commercialization of tests on the company’s FoundationOne CDx genomic profiling assay, which incorporates several companion diagnostics to cover all solid tumors.

It’s another trophy on the mantle for Foundation, which has inked companion diagnostic development partnerships with Big Pharma companies including Merck and Pfizer.


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“It is imperative that we collaborate with all of the key stakeholders in oncology to accelerate patient access to personalized medicine,” said Melanie Nallicheri, Foundation’s chief business officer and head of biopharma.

Novartis and Foundation have worked together since 2011, profiling the genes of clinical trial participants and later using Foundation’s databases in the development of oncology drugs and targets.

“This collaboration reaffirms our commitment to expedite biomarker-driven development and ultimately bring more personalized treatment options to patients,” Nallicheri added.

The latest agreement also allows for global coverage, such as in Japan, where Foundation has submitted the FoundationOne CDx assay for regulatory approval through a partnership with Chugai, which is majority-owned by Roche. If approved, the assay would be used to screen and select Japanese cancer patients for the use of targeted drugs and immunotherapies, as well as for inclusion in clinical trials.

Earlier this summer, Roche agreed to put down $2.4 billion to purchase the remainder of Foundation, following a $1 billion investment for a 56% company stake three years before. Roche plans to maintain an arm’s-length relationship with Foundation, giving it the autonomy to continue and pursue precision medicine work with other biopharma companies.

Pfizer, for example, has placed Foundation and its pan-cancer FoundationOne test, which can examine 324 genetic changes linked to cancer growth, at the center of its companion diagnostic strategy.

Meanwhile, Merck will use the test as a diagnostic for its Keytruda immunotherapy—approved for certain tumors regardless of organ site—to measure microsatellite instability as well as tumor mutational burden and treatment response biomarkers.

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