Caris launches whole tumor RNA transcriptome profiling test

Illustration of three DNA helices
Caris plans to submit the test to the FDA for premarket approval for companion diagnostic biomarkers and claims. (Darwin Laganzon)

Caris Life Sciences has launched a new whole transcriptome sequencing test for tumor RNA analysis, building upon its genomic and proteomic approaches to precision cancer treatment guidance.

The MI Transcriptome profiling test uses high-throughput RNA sequencing to detect fusion mutations, mRNA variants and expression, while ensuring that clinically relevant alterations have been transcribed from DNA to RNA.

"Our new offering covers all genes, with an average of 60 million reads per patient, to deliver extremely broad coverage and high resolution into the dynamic nature of the transcriptome,” said Caris President and Chief Scientific Officer David Spetzler. MI Transcriptome uses the same tissue requirements as the company’s DNA tumor profiling test, and delivers results in the same turnaround time.

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“Assessing the whole transcriptome allows us to dig deeper into the RNA universe to uncover and detect fusions, splice variants, and expression changes that provide oncologists with more insight and actionable information when determining treatment plans for patients,” Spetzler added.

According to Caris, the test identifies rare and novel fusions independent of the breakpoints in DNA, and covers all exons to capture possible fusion partners. It also distinguishes between different fusion types and other rearrangements, including previously uncharacterized events.

Caris plans to submit the test to the FDA for premarket approval in the first half of this year, for companion diagnostic biomarkers and claims.

The launch comes after the company raised $150 million in capital last October, its first external funding raised since 2011, in senior secured debt and convertible notes from TPG Sixth Street Partners.

In addition to supporting transcriptome test development, Caris said it would use the proceeds to continue development of other whole genome and cancer proteome profilers for treatment guidance.

Editor's note: A previous version of this article misstated David Spetzler's title, and has been corrected.

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