Guardant DNA blood take a look at finds 83% of colorectal cancers in trial, shares fall 39% By Reuters

By Deena Beasley

(Reuters) -Guardant Well being Inc on Thursday stated a pivotal trial of its DNA blood take a look at confirmed that it detected 83% of colorectal cancers and 13% of superior adenomas, a most cancers precursor, however the outcomes fell wanting a rival stool-based take a look at, sending the corporate’s shares sharply decrease.

Wall Road analysts, together with Puneet Souda at SVB Securities, had predicted the 20,000-person trial would seemingly present sensitivity of 85%-86% for colorectal most cancers and 20%-25% for superior adenomas.

Cologuard, a stool-based DNA take a look at, identifies 92% of colorectal cancers and 42% of pre-cancerous polyps, in accordance with knowledge from Precise Sciences (NASDAQ:), which markets the take a look at.

Guardant’s shares, which closed at $41.26, have been down 39% at $25 in after hours buying and selling. Shares of Precise Sciences have been up 25% at $55.99 after hours.

“We’re exhibiting for the primary time {that a} blood take a look at can actually detect colorectal most cancers with excessive sensitivity,” AmirAli Talasaz, Guardant’s co-chief govt, stated in an interview.

Guardant stated {that a} subsequent colonoscopy dominated out colon most cancers in 10% of people that examined constructive with its DNA blood take a look at.

About 70% of adults aged 50 to 75 are up-to-date with colorectal most cancers screening primarily based on all present testing sorts, in accordance with the U.S. Facilities for Illness Management and Prevention.

“It is a big unmet scientific want,” Talasaz stated of a blood take a look at for detecting colon most cancers. “There are nonetheless 50 million folks on the market who aren’t complying with colorectal most cancers screening.”

He stated Guardant expects to complete submitting its knowledge to the U.S. Meals and Drug Administration early subsequent yr, and “hopefully we get FDA approval within the very early a part of 2024.”

Pointers from the U.S. Facilities for Medicare and Medicaid Providers say the company will reimburse for blood-based biomarker colorectal most cancers screening exams with a minimal sensitivity of 74% if they’re accepted by the FDA.

Guardant is one among a number of corporations, together with Precise Sciences and Illumina (NASDAQ:)’s Grail unit, aiming to develop DNA blood exams that may detect early-stage most cancers.

Guardant is presently enrolling sufferers in a distinct trial of its DNA blood take a look at for detecting lung most cancers, Talasaz stated.