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As CRC Screening Launch Approaches, Guardant Health Plans New Comprehensive Assay


NEW YORK – Guardant Health said this week that it is gearing up for a significant milestone, with the imminent launch of its first blood-based cancer early detection assay, Guardant Shield.

During a call discussing the firm's financial results on Wednesday, Guardant co-CEO AmirAli Talasaz said that plans are "on track" for the launch of a laboratory-developed version of Guardant Shield for colorectal cancer, or CRC, screening in the first half of this year.

The firm's ECLIPSE trial, intended to support a US Food and Drug Administration submission for the assay, is also expected to read out in the middle of this year. Despite some slowdown with the recent COVID-19 resurgence, Talasaz said Guardant still anticipates submitting its premarket approval package to the FDA in the latter part of this year and to receive approval in 2023, "pending successful review by the agency."

"Our strategy this year is to engage in commercial development activities that will accelerate adoption of Guardant Shield post-FDA approval," Talasaz said. This includes engaging stakeholders and increasing awareness among primary care physicians.

"We are pleased with the early feedback we are hearing and the high interest in blood-based CRC screening. It is increasingly clear that there is a significant unmet need … [and] we believe that a successful early clinical experience with Guardant Shield and confirmation of its potential impact in improving compliance rates will be instrumental to drive long-term adoption of the test," he said.

According to Talasaz, Guardant has onboarded an approximately 100-member commercial team targeting the primary care community and is planning to gradually expand that team to over 700 members by 2026, when the firm expects the test to be included in guidelines by the US Preventive Services Task Force.

Adding to the pipeline

Guardant also said this week that it has already turned its eye to a new project — an expansion of its flagship liquid biopsy assay Guardant 360.

Guardant co-CEO Helmy Eltoukhy said during the company's call that Guardant plans to launch within the year what he called a "smart" liquid biopsy, with a genomic footprint nearly 100 times larger than the current companion diagnostic version of its 360 test including epigenomic and immune signaling information in addition to genetic alterations.

"We believe [this] will be a quantum leap forward," Eltoukhy said, "enabling a rich ecosystem of countless applications ranging from deep analysis of tumor genomics, interrogation of the tumor microenvironment, diverse immuno-oncology applications, much more sensitive therapeutic monitoring, identification of complex prognostic signatures, and many others."

The development of this broader assay stands to align Guardant with other firms in the field offering multiomic platforms for comprehensive genomic profiling, such as Caris Life Sciences and Personalis.

The company hasn't provided technical details about the test, but Eltoukhy said that as is typical for the firm, it will be launched initially for biopharma customers later this year, then for clinical use shortly thereafter.

Talasaz also discussed Guardant's evolving plans to transition Guardant Shield, currently for CRC screening only, to a multi-cancer screening assay, with lung cancer as its next planned indication. He further pointed out that like CRC, lung cancer already has a defined screening paradigm.

"Lung cancer is the leading cause of cancer-related death in the United States and symptoms typically do not appear until the disease is already at an advanced stage," Talasaz said, adding that current guidelines recommend annual lung cancer screening for high-risk individuals.

Despite this, screening compliance studies have suggested significant underutilization, with only around 14 percent of people eligible actually up to date with recommendations.

Guardant is currently validating its technology in a prospective registrational study called SHIELD lung, which, like ECLIPSE, is designed to provide evidence necessary for a regulatory submission.

The trial is recruiting a planned 10,000 individuals between the ages of 50 and 80 who undergo standard-of-care screening for lung cancer using low-dose CT. All subjects enrolled in SHIELD LUNG will be at high risk for lung cancer. Talasaz said Guardant has already enrolled its first patient in the trial and expects to complete enrollment within 36 months.

Although multi-cancer early detection firm Grail was first to the blood-based screening market with the launch of its Galleri assay last year, its multi-cancer assay faces a complex path to gaining Medicare reimbursement, which will be necessary for broad adoption.

With its ECLIPSE timeline, and the fact that the Center for Medicare and Medicaid Services' MolDx program has already issued a positive local coverage determination for colorectal cancer blood-based screening, Talasaz said he believes Guardant "can be the first to have a blood-based cancer screening test with Medicare coverage and FDA approval" on the market.

Data for additional cancer types is also slated for presentation or publication "throughout 2022," he added.

Although the Guardant Shield CRC LDT will launch this year, Talasaz cautioned that revenues from the new test have not been built into the company's guidance.

"In the early days, since we don't have any coverage policies or any payments by payors, we expect very minimal [revenue]," he said. The first major reimbursement that Guardant is expecting is Medicare coverage, but Talasaz said that growing a larger payor base will need to wait on FDA approval, which the firm currently expects in 2023.