The FDA has approved DNA sequencing giant Illumina’s cancer test that checks more than 500 genes in a tumor to potentially match patients with targeted therapies from Bayer or Eli Lilly.
Illumina has sought to aid drugmakers and their search for patients who qualify for their drugs.
The company’s TruSight Oncology Comprehensive test kit is approved to find patients who might benefit from Bayer’s Vitrakvi, aimed at neurotrophic tropomyosin receptor kinase gene fusions, and Eli Lilly’s Retevmo, which targets lung cancers driven by gene mutations known as RET, or rearranged during transfection.
Foundation Medicine markets a similar test, which is also FDA-approved as a companion diagnostic for a range of treatments, including Vitrakvi and Retevmo.
Illumina’s test was already on the US market as a research product. But the agency’s decision allows for commercialization and sets up Medicare and Medicaid reimbursement under a government provision, Illumina said in a news release.
In 2022, the test was cleared for use in Europe.
Shawn Baker, who runs the genomics consulting firm SanDiegOmics, told Endpoints News that the approval marks a step forward for Illumina’s expansion into the clinical arena. Much of the company’s current business is derived from researchers.
“Illumina has been trying to expand into the clinical space for a long time,” Baker said.
The approval also shows that Illumina hasn’t given up on cancer detection after the company divested Grail in June. Increasingly, diagnostics companies are moving toward tests that screen for a narrower set of cancers than Grail’s broad offering.