Saga Diagnostics expanded the use of its ultrasensitive blood test to include detection of tiny amounts of colorectal cancer that may remain in the body after treatment and can signal a higher risk of recurrence.
The Pathlight MRD test debuted for use in molecular residual detection last May and received Medicare coverage for breast cancer in July. The test looks for small fragments of circulating tumor DNA (ctDNA) that are introduced into the bloodstream by the cancer and serve as biomarkers for detection. Such detection can then drive personalized treatment decisions.
Saga’s move to expand into colorectal cancer is supported by a study the company touts as one of the largest real-world ctDNA studies focused on colorectal cancer. The study included 377 patients, of which about 150 had rectal cancer.
Slightly more than 42% of the ctDNA-positive patients had MRD that was detectable only at ultrasensitive levels, underscoring the strength of the Pathlight test, the company said in a Jan. 12 press release.
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“The colorectal data from CITCCA (the study) builds on the strong foundation Pathlight has established in breast cancer,” Vicki Fish, a Saga senior vice president, said in a statement. “Pathlight detects molecular residual disease at extremely low levels—months ahead of clinical recurrence—opening new opportunities for earlier intervention. Bringing ultrasensitivity and high prognostic value to colorectal cancer represents a major step forward in our mission to enable more precise, personalized care.”
Saga spun out of Lund University in Sweden in 2016 with the goal of quantifying aberrations in DNA, RNA and strands of ctDNA in the bloodstream by using massive parallel sequencing and digital PCR.
Its sequencing tech can detect mutant allele fractions as low as 0.001%—representing the number of mutant or variant reads compared to the total amount—making it more accurate than other PCR and next-generation sequencing methods.
