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Guardant Health Announces Plans for Prospective Colorectal Cancer Screening Study

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NEW YORK (GenomeWeb) – Guardant Health said this week that it is planning a large prospective clinical trial to test the ability of its Lunar liquid biopsy assay to detect colorectal cancer in asymptomatic individuals.

During a conference call yesterday to discuss the firm's first quarter earnings, President and Chief Operating Officer AmirAli Talasaz noted that Guardant shared data on the use of the Lunar assay for detecting cancer in patients recently diagnosed with colorectal cancer (CRC) at the American Association for Cancer Research annual meeting in Atlanta last month. The data showed the test had "80 percent sensitivity with specificity in the mid-90s for detection of colorectal cancer in early stages in a cohort of 225," he said.

"We believe this initial data represents some of the most compelling performance shared to date for a blood-based approach for early colorectal cancer detection and shows the potential of using this test for screening average-risk, asymptomatic individuals," Talasaz said.

Though several analysts pressed the company for more detail, Guardant officials provided little additional information on the study design, performance metrics, and costs of the trial during the call. The firm is planning for a cohort of more than 10,000 patients and expects to start the trial in the second half of 2019. Guardant CEO Helmy Eltoukhy said the company would try to provide more details after the release of its second quarter results.

Guardant's Lunar assay, a commercial research-use-only assay for early cancer detection, combines both genomics and epigenomic analyses.

Analysts differed in their assessment of the planned trial, with some suggesting it might be too early for such a study.

"This appears in-line with [Guardant management's] ambitions and the confidence it obtained from Lunar CRC data at AACR, but [is] still ahead of our expectations on timing and trial size," SVB Leerink analyst Puneet Souda wrote in a note to investors.

William Blair analyst Brian Weinstein wrote in a note that he "did not believe [the AACR data] was good enough to support anything other than other validation work to try to drive sensitivity higher. The more typical pathway here would be to do validation work on an ever increasingly challenging patient population to have confidence before moving ahead with such a large, expensive, and time-consuming initiative."

He added that in a post-call discussion, "management was clear this was a calculated risk and success was far from certain, but the team felt some of the data it has generated (and not shared entirely) and the opportunity to bring a blood-based screening test to the market made this the right time to go forward."

Guardant officials declined to say whether they were trying to follow the path to market laid out by Exact Sciences and its Cologuard test, an FDA-approved noninvasive molecular test for CRC screening that uses fecal DNA. Other companies developing molecular tests for colon cancer screening include Epigenomics and its Epi proColon test and companies pursuing pan-cancer blood-based tests, such as Grail, which would include CRC detection.

Souda said that the announcement "is likely to put pressure on [Exact Sciences] and raise questions around [Exact Sciences] own CRC blood data - which it has not shown yet. Still, we believe investor reaction is likely to be skewed in favor of [Exact Sciences] for now given that Cologuard is approved, reimbursed and on the market vs. [Guardant's] assay that still has to prove itself with the US Food and Drug Administration, guidelines, and reimbursement."

Weinstein said the announcement "does not impact our view on Exact Sciences as there is no new data here and any program is years away from being on the market, if it is even successful in trials."