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Guardant Health Laying Path for Future in Cancer Screening, Updates Launch Plans for CRC Assay

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NEW YORK – As it prepares to launch its first test for the cancer screening market next year, Guardant Health is taking steps to reorganize its corporate structure to support what it hopes will be a leadership role in early detection.

The Redwood City, California-based company provided an update on its evolving plans this week during a call discussing its Q2 financial results, announcing that current CEO Helmy Eltoukhy and AmirAli Talasaz, president and chief operating officer, will adopt co-CEO roles moving forward, with Eltoukhy leading the firm's established cancer genomics business and Talasaz shepherding activities in the screening space, where Guardant has developed a DNA methylation-based blood test initially targeted at colorectal cancer.

Talasaz estimated that the blood-based screening market for colorectal cancer, Guardant's first target, represents a $20 billion opportunity, and said that the company's plans to expand to other cancer types would pave the way toward a total addressable screening market of more than $50 billion.

According to Eltoukhy, the move to split its business and separate screening as a standalone arm is a testament to the confidence Guardant has "and the scalability of the future that we want to set up." He also suggested that this scalability could reach beyond areas the firm is currently targeting, hinting at the potential of non-cancer targets.

"We're not making any announcements around those areas, but we do know that our platform, has … I think, the capabilities of addressing other areas of healthcare," Eltoukhy said.

Among its newly crystalized plans for cancer screening, Guardant said that it expects to launch its colorectal cancer screening assay within the first half of next year, initially as an LDT, but with an expectation of gaining FDA clearance in 2023.

The company has been validating the assay in a prospective trial called ECLIPSE, which it said this week has recruited 10,000 patients. Based on the incidence of CRC in the trial so far, the company said it needs to add 3,000 more subjects to appropriately power the study, but it can do this within its previously stated timeline.

The decision to launch initially as an LDT mirrors the strategy that other companies in the blood-based cancer screening space have recently adopted, including Grail, which debuted its multi-cancer assay Galleri as an LDT in June.

"We're still expecting … that this goes on to FDA review … and that would be the major commercial push for us," Talasaz said. But in the meantime, Guardant believes it will be important to start "shaping the market" and laying groundwork.

"We want to generate experience for the field, integrating our test with the right health networks … [and establishing] blood-based screening into PCP workflows," he added.

Talasaz said that Guardant has already begun building leadership for a screening-specific commercial channel, and the company is confident it will have the operational infrastructure needed to support the planned LDT launch.

He added that the company still plans to target the same average-risk population with this pre-FDA launch. Having said that, "we don't expect major adoption before FDA approval," he said.

The rationale for providing an LDT more reflects Guardant's perception of a desire for immediate access among early adopters. "They really want to use our test sooner [rather] than later," Talasaz said.

As the firm awaits completion of the ECLIPSE trial, it has continued to add other evidence for the performance of its methylation-based screening technology, including in additional tumor types.

Among presentations at the annual meeting of the American Society of Clinical Oncology earlier this summer, Guardant shared data from an analysis of CRC patients and aged-matched controls tested with its assay. Investigators reported 88 percent sensitivity in stage I-II patients and 93 percent sensitivity in stage III patients with an overall specificity of 94 percent.

The company also highlighted ASCO data showing that its technology could detect the presence of ctDNA in early-stage non-small cell lung cancer and bladder cancer patients, reporting sensitivity for a non-small cell lung cancer assay between 48 percent and 90 percent depending on stage. Sensitivity for bladder cancer was up to 67 percent.

In addition to building data in a larger group of cancer types, Talasaz said Guardant is also working now on linking its technology to synergistic or adjacent platforms, including a new partnership with a company called Lunit, which is developing an AI-powered radiology and pathology solution.

According to Talasaz, the goal is to better streamline the "screening journey" for patients. "We believe that the multimodal and integrated screening paradigm can offer tremendous value … [so[ this is an important aspect of our overall strategy, and we will continue looking for strategic opportunities over the coming quarters," he said.

"When you think about the future of screening, we believe blood-based assays are very important, but cannot be the only [thing] there," he added. "We need to put some kind of additional solution on the front end and back end to [ensure] a good experience and workflow for patients and providers."

Guardant's CRC screening test will be the second launch featuring a DNA methylation-based approach. The firm has already released a separate test using the same technology called Guardant Reveal, intended for the detection of minimal residual disease in patients who already have cancer but are being treated with curative intent.

Guardant's entry into the molecular MRD market has invigorated debate over the relative merits of tissue-agnostic approaches like the Reveal assay versus patient-specific, tissue-informed tests from companies like Natera. Guardant and Natera recently became involved in a legal dispute over their respective marketing claims.

On the call this week, Eltoukhy said that despite this heated competitive background, Guardant has not seen much pushback in its marketing of Reveal, "regardless of whether physicians are existing or new users" of this new class of tests.

The company didn't break down adoption and earnings associated with the new test, but Eltoukhy said that Guardant is seeing "good traction."

"It's just logistically a very straightforward test that fits in to how physicians currently order tests like CEA and how they practice medicine," he said.

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