GRAIL NASDAQ: GRAL said demand for its Galleri multi-cancer early detection test has continued to grow despite recent headlines related to its NHS study, according to comments made by Aaron, who identified himself during the discussion as the company’s CFO, at a Bank of America event.
Aaron said the NHS update prompted more questions from current and prospective physician customers, but he said physicians who looked beyond the headline focused on clinical utility measures including a reduction in Stage 4 cancers, an increase in Stage 1 and Stage 2 detections, decreased emergency room presentations and four times more cancers found than standard of care.
“Everybody wants to see the ASCO data,” Aaron said, referring to the upcoming presentation expected at the end of the month. He said GRAIL has expanded its field team, sales force and medical sales team so they can use updated materials and educate physicians once the data are presented.
NHS Discussions Expected Over Next 12 Months
Asked about next steps with the NHS, Aaron said GRAIL has an agreement tied to the trial and that the company has met some of the clinical utility endpoints included in that process. He said future discussions with the NHS will involve “a balance of politics, budget, and data,” and are expected to take place over the next 12 months.
He added that the NHS has “a lot going on” as it evaluates how it operates with the government, but said GRAIL continues to talk with NHS officials and looks forward to discussing “how and if this gets implemented in their population.”
Aaron said he does not expect the upcoming ASCO presentation to change those conversations, noting that key people at the NHS have already been “read in” on the data.
FDA Review Continues After January Submission
On the regulatory front, Aaron said GRAIL has been in the FDA’s breakthrough program since 2018 and submitted its review package in January. He said the FDA has accepted the package and that the review is ongoing.
He said the NHS Galleri data being included in the package were first-year performance data, not the primary endpoint of the NHS study. Aaron said GRAIL has repeated its performance results across multiple studies, including interventional and case-control studies, and said the company is confident in the package under review.
Asked whether the NHS update had changed the tone of FDA discussions, Aaron said, “No.”
He said the FDA has publicly described a 180-day review timeline if no advisory committee meeting is held, and a 320-day timeline if an advisory committee is convened. GRAIL does not yet know whether there will be an advisory committee meeting, but Aaron said the company is preparing for one.
Commercial Growth Driven by Self-Pay and Physician Adoption
Aaron said Galleri remains primarily a self-pay test, with about 70% of volume coming from self-pay customers. He said growth is being driven by brick-and-mortar physician offices, where both the number of ordering physicians and repeat ordering by existing physicians have expanded.
He pointed to integrations and partnerships with athenahealth, Quest Diagnostics and Epic Systems as tools that can support adoption. GRAIL has announced plans to implement Epic by the end of the year.
Aaron also cited digital health channels as an emerging growth opportunity, naming Function Health, Everlywell and Hims & Hers. He said these platforms reach consumers who are already engaged in managing their health and may be willing to pay out of pocket for testing.
In traditional physician channels, Aaron said GRAIL added about 1,300 physicians last quarter, if he recalled correctly. He said awareness is being driven by medical education, social media advertising and physician groups that allow doctors to share experiences with the test.
He said GRAIL’s retest rate is now above 30%, which he described as encouraging given that the test is not reimbursed. He compared that figure with other screening tests that have reached about a 30% retest rate after a decade of reimbursement.
Reimbursement, Scale and Cost Structure Remain Key Focus Areas
Aaron said GRAIL was built for broad population access and has infrastructure capable of running more than 1 million tests annually at its RTP lab, with room to expand significantly within the same building footprint.
He outlined multiple potential paths to reimbursement and broad access, including international opportunities with the NHS and other partners, as well as U.S. pathways involving the REACH study, CMS, MCED legislation and possible RAPID rules that could allow FDA and CMS to work together more quickly on reimbursement for breakthrough-approved devices.
According to Aaron, the REACH study is enrolling participants over three years, with three blood draws per participant and a final readout expected around early 2031. He said the intent is to provide interim data for CMS, alongside NHS data and real-world evidence. GRAIL has performed more than half a million commercial tests to date, he said.
On costs, Aaron said GRAIL’s current test version is designed to support margins in the 50% to 60% range at reimbursement levels of slightly above $500 per test, which he linked to MCED legislation. He said margin improvement should continue as the company grows into its fixed-cost laboratory infrastructure, and that further cost reductions could come from scale and technology changes.
Competition and Long-Term Strategy
Aaron said additional companies entering the multi-cancer early detection market have helped raise awareness among physicians. He said GRAIL remains differentiated by what he described as interventional and prospective data, as well as its FDA submission.
He also said GRAIL has capabilities in minimal residual disease, therapy selection and recurrence monitoring, but that the company remains focused on multi-cancer early detection. He said GRAIL has about $830 million on its balance sheet and may consider other product applications when the timing is right, but added that investing outside screening now would be premature.
Asked what is most misunderstood about GRAIL, Aaron said the company’s opportunity is to find cancers beyond those detected by existing standard-of-care screening. He said standard screening detects about 14% of cancers in the population, and argued that adding one test with a low false-positive rate could make cancer detection more efficient.
“It’s probably the best shot we have at finding, at bending the cancer mortality curve,” Aaron said.
About GRAIL NASDAQ: GRAL
GRAIL, Inc NASDAQ: GRAL is a biotechnology company dedicated to the early detection of cancer through a multi-cancer blood test. Leveraging advances in next-generation sequencing, cell-free DNA (cfDNA) analysis and machine learning, GRAIL has developed the Galleri™ test, which aims to identify more than 50 types of cancer at their earliest stages. The company's platform analyzes methylation patterns in circulating tumor DNA to pinpoint tumor presence and tissue of origin, enabling physicians to pursue timely diagnostic follow-up.
Founded in 2016 as a spin-out from Illumina, GRAIL established its headquarters in Menlo Park, California, with additional research and operations centers in the United Kingdom.
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