Guardant Health has its sights set on redefining how people get checked for colorectal cancer, and its blood test for catching stray tumor DNA soon has a date with the FDA.
The agency has scheduled an advisory panel meeting May 23 to help evaluate the company’s Shield test, which is seeking an in vitro diagnostic approval for screening people ages 45 and up that have an average risk of developing the malignant disease.
The FDA’s committees of independent experts typically offer an outside perspective either for or against the approval of a product after discussing its risks, benefits and potential impact. The agency’s reviewing staff take their recommendations into consideration, but they are not obligated to follow them.
“The interesting thing is that there have not been many of these specific advisory committee meetings, especially in our specific field,” Guardant co-CEO AmirAli Talasaz said in an interview during the Milken Institute’s Global Conference in Los Angeles.
“The last time that this adcomm had some kind of review of a device under consideration for approval was about 10 years ago,” Talasaz said. “So there's not a lot of precedent to look into, but we are very excited to maybe pave a path for other kinds of applications in cancer screening down the road, by us or by others.”
Though the FDA has not yet posted a full agenda, discussion questions or documents—which typically appear in the days just before the meeting—what is expected to play a central role is the company’s ECLIPSE study, which had its results published earlier this year in The New England Journal of Medicine.
That clinical trial, which evaluated more than 7,800 people, found that among patients who had colorectal cancer confirmed by a colonoscopy exam, 83.1% could also be correctly identified by Guardant’s cell-free tumor DNA blood test. At the same time, people that had no signs of colorectal cancers or advanced precancerous lesions were labeled as such at a rate of 89.6%.
The Shield test is not being pitched as a complete replacement for colonoscopy but as an early screening option that will help funnel the people who need to be checked the soonest toward scheduling a full exam.
Guardant estimates that—with colorectal cancer being the second-leading cause of cancer-related deaths in the U.S., and more than 150,000 new diagnoses annually—about 75% of the people who die from the disease have not been up to date with current screening guidelines. In addition, colorectal cancer can be very treatable if it is caught early.
“There are many patient stories that we hear where they've never done colonoscopy, for many different kinds of reasons,” Talasaz told Fierce Medtech. “When the Shield test finds an abnormal signal, a very good fraction of them—people who have avoided colonoscopy all their lives—are, in fact, doing it. That’s the beauty of what we’re offering.”
Technically, Shield has been available to the public since mid-2022, reaching the market as a prescribed, lab-developed test; Guardant said it has since been used to screen more than 20,000 people. The test was submitted for FDA review in March 2023.
And when it comes to leveraging the real-world data gathered from that usage and putting the information toward a full approval, Talasaz said that has been the subject of conversations with agency staff—as the company seeks a full diagnostic approval to help it get a leg up toward reimbursement coverage.
But that’s a window that may be slowly closing for test developers: Late last month, the FDA finalized its regulatory rule to phase in increasing oversight of lab-developed tests, or LDTs, to bring them more in line over the coming years with how the agency currently addresses other medical devices and in vitro diagnostics.
“From our perspective, LDTs have some kind of value in terms of the cycle of innovation—getting some feedback from the market and optimizing the offering based on the customer needs,” Talasaz said. “Over time, that can lead to better products.”
Still, the company has said it largely expects to continue to operate as it does now.
“If the regulation happens the right way, I think that could be a net-net win for Guardant—we’re an in vitro diagnostics company,” he said. “In terms of population safety and product quality, it could be good if it's implemented properly. And, actually, we are supportive of some of these changes—but the landscape will evolve.”
Guardant will also need to work to court the blessing of the U.S. Preventive Services Task Force (USPSTF), which evaluates different types of screening tests and makes recommendations that can lead to insurance coverage.
The USPSTF last updated its colorectal cancer screening guidelines in 2021, saying all adults between the ages of 45 and 75 should get checked out, including with a stool test each year or a colonoscopy every 10 years. At the time, the task force said it did not include serum or blood tests because of the limited evidence available.
Since then, Guardant has said its Shield test has demonstrated performance “on par” with other noninvasive screening methods, which have historically put forward sensitivity rates between 74% and 92%.
“One thing that’s noted by the task force is the value of choices for patients,” Talasaz said. “They're recommending five to six different modalities … But they’re not ranking them, or saying do this first, do this second. They are noting that the power of choice is very important.”
“So we are expecting that when blood-based testing goes through the review process, that the same kind of mentality can be applied—because we really need to give patients and providers the power of choice in the end, in order to really improve the overall compliance rate.”
Last week, Guardant also released its first-quarter earnings report, posting a 31% gain for $168.5 million in revenue.
That haul came in following a 20% gain in clinical test volume over the same period the year prior, for 46,900 results delivered. Cancer biopsy tests sold to biopharma companies for use in clinical studies, meanwhile, grew 37% to 8,450.
“We also saw continued progress in our EMR integration efforts which streamlines orders and workflows for physicians,” Guardant’s other co-CEO, Helmy Eltoukhy, said on a call with investors. “Notably, more than one-third of our orders in the first quarter were digital, showing the effectiveness of the integration process.”
The company bumped up its revenue projections for the remainder of the calendar year, forecasting about 20% growth to between $675 million and $685 million—though those figures do not include any potential gains from its Shield screening test, pending the completion of the FDA’s review.