FoundationOne CDx, from Foundation Medicine, Cambridge, Mass, has received FDA approval for use as a companion diagnostic for Vitrakvi (Larotrectinib), which is currently FDA-approved 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.

NTRKfusion-positive cancer occurs when a piece of the chromosome containing the NTRK gene breaks off and binds to another chromosome. These NTRKgene fusions produce TRK fusion proteins, which may cause cancer cells to grow.  NTRKfusions are more commonly found in rare cancer types, such as secretory carcinoma of the breast or salivary gland and infantile fibrosarcoma, but they can also occur across many more common cancer types including glioma, melanoma and carcinomas of the lung, thyroid, and colon.

“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,” says Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine. “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 is the first FDA-approved broad companion diagnostic that is clinically and analytically validated for solid tumors. The tissue-based comprehensive genomic profiling test is currently approved as a companion diagnostic for more than 20 targeted therapies.

“Many patients with rare conditions, like NTRKfusion-positive cancer have limited treatment options and poor access to targeted therapies,” says Susan Spinosa, co-chair and patient founder of the NTRKers. “This companion diagnostic approval is a critical step forward in addressing this challenge as it provides this patient population with broader access to comprehensive genomic testing and appropriate treatment options.”

For more information, visit Foundation Medicine