July 2023 Business Update
July 28, 2023

Galleri®, our novel multi-cancer early detection test, continues to see strong commercial progress in health systems, clinics and the employer and life insurance channels across the U.S.

In the second quarter of 2023, GRAIL achieved our first 100,000 commercial Galleri test milestone. Galleri has now been prescribed by more than 7,500 providers in the U.S., and ordered in more than 80 health systems. We continue to be encouraged by the enthusiasm to implement multi-cancer early detection screening as we work towards detecting cancer early, when it can be cured.

Revenue in the second quarter of 2023, comprised of Galleri test sales and biopharmaceutical business revenue, increased to $22 million. Galleri commercial volume for the year has surpassed 50,000, and we are on track to meet our revenue guidance of $90-110 million for full year 2023.

In addition, we presented groundbreaking research at the American Association for Cancer Research (AACR) Annual Meeting 2023 in April, and the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June. Highlights of recent research presented include evaluations of Galleri implementation programs in health systems and medical practices and the first data for GRAIL’s multi-cancer early detection (MCED) technology in symptomatic individuals. Research presented also included analytic validation data for GRAIL’s methylation-based post-diagnosis research solution and feasibility data for a pan-hematologic malignancy classifier. We also recently published manuscripts in renowned journals The Lancet Oncology, the AACR’s Cancer Epidemiology, Biomarkers, & Prevention, and JCO Precision Oncology.

Business highlights

    • In April, GRAIL and FirstHealth of the Carolinas, a private, not-for-profit health system serving patients in 15 counties in the mid-Carolinas, announced the availability of Galleri to eligible patients as part of its comprehensive cancer screening and care. Galleri has now been prescribed in more than 80 health systems throughout the U.S.
    • In April, GRAIL presented research at AACR, including:
      • Analytical validation for GRAIL’s methylation-based Research Use Only post-diagnosis solution. Results demonstrated strong analytical sensitivity, specificity and precision of the tissue-free research test, which was launched earlier this year.
      • In partnership with AstraZeneca, new data from a study assessing the feasibility of a pan-hematologic malignancy classifier based on GRAIL’s methylation platform as a potential tissue-agnostic, plasma-based cell free DNA (cfDNA) minimal residual disease (MRD) test. The study showed that GRAIL’s methylation technology had a cancer detection rate of 92% in patients with relapsed or refractory disease across six hematological malignancies, with 96% accuracy in determining hematologic malignancy subtype.
    • In June, GRAIL presented 10 posters and oral abstracts at ASCO, including:
      • In partnership with the University of Oxford, results from the prospective SYMPLIFY study presented during an oral session. SYMPLIFY is the first large-scale evaluation of an MCED test in individuals who presented to primary care and were referred for diagnostic follow-up for suspicion of cancer due to symptoms. The analysis showed strong performance of GRAIL’s MCED methylation-based platform in the symptomatic population of more than 6,000 patients, including test sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). In addition, many diagnosed cancers were “off-target” to those inferred by the symptoms that led to referral, demonstrating the benefit of a multi-cancer test with highly accurate cancer signal origin prediction in patients with symptoms. These results, which were subsequently published in The Lancet Oncology, demonstrate the feasibility of using an MCED test to assist clinicians with decisions regarding urgency and routes of referral from primary care.
      • A retrospective analysis of the interventional PATHFINDER study to assess whether diagnostic evaluations of individuals who received a cancer signal detected (CSD) result with the Galleri test were appropriately directed by the test’s cancer signal of origin (CSO) predictions. The findings demonstrated that in 78% of cases, the test’s CSO-directed initial diagnostic evaluation led to a diagnostic resolution.
      • A real-world analysis of the Galleri test’s ability to detect a cancer signal and predict the CSO in asymptomatic individuals. The initial findings support real-world performance of Galleri – including the CSD rate and accuracy of the CSO prediction to guide diagnostic workup – consistent with previous large-scale clinical studies such as PATHFINDER. Positive Galleri results with a CSO prediction were associated with a diagnosis of invasive cancer across multiple cancer types, including stage I and II cancers.
    • In July, we completed second year study visits for the NHS-Galleri study. 130,000 participants came back for their second appointment which, after completed blood draws, gives us an outstanding retention rate of 91.3%, well ahead of our target retention rate. Invitations for final (third year) study visits commenced in July, and the first appointments are expected in mid-September.