The FoundationOne RNA test was previously only available for research and investigational use. Image Credit: ArtemisDiana / Shutterstock.

Boston-based Foundation Medicine has started the commercial launch of its RNA sequencing test FoundationOne RNA in the US.

FoundationOne RNA can be used to detect fusions in solid tumours and may also be used in other cancers such as non-small cell lung cancer (NSCLC), pancreatic cancer, cholangiocarcinoma, sarcoma, thyroid cancer, and bladder cancer.

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The RNA sequencing test can be used in conjunction with the company’s tissue-based DNA sequencing test, FoundationOne CDx, which has been approved as a companion diagnostic for all solid tumours by the US Food and Drug Administration (FDA). The company also offers a blood-based alternative for DNA sequencing, FoundationOne Liquid Dx, for use in blood cancers.

Foundation Medicine also offers the results from both the RNA and DNA sequencing tests in a single report, allowing physicians a better picture of cancer genomics and informing a targeted therapeutic selection. The report includes “detected alterations, potential therapies, and available clinical trials for physicians to consider for each unique patient”.

“In recent years, there has been an abundance of newly approved therapies to target fusions, many of which are for NSCLC,” said Foundation Medicine’s chief medical officer Mia Levy.

“By offering both DNA and RNA testing options for fusion detection and delivering fast and accurate results considering the instability of RNA, physicians and our research partners can rely on Foundation Medicine for greater confidence in fusion detection.”

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The use and development of companion diagnostics has increased in recent years. Multiple companies have developed companion diagnostics for high-profile therapies. One of the areas where companion diagnostics are gaining increased traction is oncology. The market for oncology tests is expected to grow from being worth $1.9bn in 2022 to over $3.1bn in 2030, according to GlobalData analysis.

In March, Bayer and Thermo Fisher Scientific entered a collaboration to develop next-generation sequencing-based companion diagnostic assays (CDx). The assays will be used to screen patients eligible for Bayer’s precision cancer therapies.

In November 2023, Foundation Medicine and Pierre Fabre Laboratories signed a partnership to develop companion diagnostics for NSCLC. The diagnostic will be used to detect patients who can benefit from Pierre Fabre and Pfizer’s combination regimen of Braftovi (encorafenib) and Mektovi (binimetinib).