FoundationOne CDx Wins Approval as Companion Diagnostic to Vitrakvi

The test’s approval adds one more compelling layer to the liquid biopsy story in 2020.

Omar Ford

October 26, 2020

2 Min Read

Foundation Medicine won approval for its FoundationOne CDx to be used as a companion diagnostic to Vitrakvi.

The pharma solution is developed by Loxo Oncology, an Eli Lily company, and was awarded accelerated approval from FDA in November of 2018. Vitakvi is used for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

The Cambridge, MA-based company said FoundationOne CDx, is the only FDA-approved tissue-based comprehensive genomic profiling (CGP) test, now approved to detect NTRK1/2/3 fusions across all solid tumor types and identify patients who may be appropriate for treatment with Vitrakvi.

“Taking a comprehensive and validated approach to genomic testing is critical for all advanced cancer patients, but especially for those harboring rare mutations that can be missed with alternative testing methods,” Brian Alexander, M.D., M.P.H., CMO at Foundation Medicine, said in a release. “Not only will this approval improve access to genomic testing and reinforce the role it plays in rare cancers, but it also confirms the incredible progress made toward tumor-agnostic cancer care. We’re proud of the impact this will have on NTRK fusion-positive cancer patients.”

FoundationOne CDx has been approved to be a companion diagnostic of more than 20 different therapies.

2020 has been a huge year for liquid biopsy.

On the approval side, Foundation won a nod from FDA for a pan tumor test in late August. Foundation’s pan tumor test analyzes more than 300 cancer-related genes for alterations.

The pan tumor test’s approval followed closely behind Guardant Health securing FDA approval for a liquid biopsy solution for comprehensive tumor mutation profiling across all solid cancers.

On the business side, Grail made some moves that paved the way for it to end up exactly where it started. The company filed for an initial public offering with a placeholder amount of $100 million last month. However, gene sequencing specialist Illumina, the company Grail was spun-out from, made an offer to acquire the liquid biopsy firm for $8 billion.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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