Together, Illumina and Grail Will Usher in A New Era of Cancer Detection
Illumina’s acquisition of GRAIL will accelerate the global adoption of Galleri, the only blood test capable of detecting more than 50 different types of cancer with >99% specificity. But GRAIL currently faces a number of hurdles to widespread distribution and adoption. The longer it takes to bring Galleri to market, the more lives will be lost.
Illumina is uniquely positioned to bring Galleri to as many patients as possible, as quickly as possible. In Europe, for example, Illumina successfully launched a clinical NGS-based blood test at scale, with the roll-out of our NIPT test following the acquisition of Verinata in 2013. Illumina also has significant experience obtaining regulatory approvals for NGS systems and tests in more than 50 countries worldwide and has helped to obtain reimbursement for over one billion people globally for tests across NIPT, cancer therapy selection, and genetic diseases.
GRAIL on its own does not have this experience. Illumina will use our valuable expertise, as well as our relationships with European healthcare systems, laboratories and KOLs to help GRAIL overcome the significant hurdles it currently faces, such as obtaining regulatory approval under the stringent IVDR, securing payor reimbursement across the diverse EEA landscape, and achieving production and distribution of its test at scale. With these capabilities, Illumina will accelerate GRAIL’s commercial entry into the EEA at scale by at least five years.
This is a transformative moment for early cancer detection. While COVID rightly continues to dominate the world’s headlines, cancer remains one of the biggest health threats globally. The disease kills around 10 million people annually worldwide, including 1.9 million people in Europe1 and nearly 600,000 people in the United States2. But, if we diagnose cancer early, about 90% of patients are expected to survive beyond five years. GRAIL’s Galleri test can detect more than 50 cancers across all stages.
The merger of Illumina and GRAIL will save tens of thousands of people from cancer by making Galleri widely available and affordable.
In 2021, Illumina made available a 12-year supply contract to any U.S. oncology customer. Among other commitments, this open offer guarantees the continued supply of Illumina’s products and support to oncology customers at the same price GRAIL pays and guarantees to make our latest technologies available on the same terms that GRAIL receives, along with a guaranteed significant price reduction over the coming years.
The merger of Illumina and GRAIL is still facing pending legal challenges on antitrust grounds in both the US and EU. In the US, the FTC’s Chief Administrative Law Judge found no harm to competition and dismissed FTC’s complaint. FTC has appealed that decision. Fourteen diverse organizations filed briefs in support of our appeal, which can be found here. We continue to believe that this merger is pro-competitive, and we look forward to resolving these challenges to accelerate the availability and affordability of the Galleri test to save lives.
To learn more, read recent news coverage, as well as our briefing paper. Click here for more information.
1 https://canceratlas.cancer.org/the-burden/europe
2https://www.cdc.gov/cancer/dcpc/data/index.htm
Accelerates Adoption of NGS-Based Early Multi-Cancer Detection Test to Reach More Patients Faster
Illumina will leverage its global scale, manufacturing and clinical capabilities to lead GRAIL’s commercialization efforts, realize the total addressable market potential and drive significant growth in the clinical value chain
Enhances Illumina’s Position in Clinical Genomics
NGS is poised to revolutionize oncology care, and this acquisition allows Illumina to participate more fully in the high value clinical solutions that are enabled by its NGS sequencing technology. With GRAIL, Illumina will continue as a leading sequencing innovator and partner, while also becoming a proprietary test provider.
Detecting Cancer Early, When it Can be Cured
71% of cancer-related deaths are in cancers with no recommended screening
Source: SEER Program (www.seer.cancer.gov) *Stat Database: Incidence – SEER 18 Regs Research Data, Nov 2018 Sub. Includes persons aged 50-79 diagnosed 2006-2015 “Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin, “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body. Noone AM, Howlader N, Krapcho M, et al. (eds). SEER Cancer Statistics Review, 1975-2015, National Cancer Institute, Bethesda, MD, http://seer.cancer.gov/csr/1975_2015/, based on November 2017 SEER data submission, posted to the SEER website April 2018.
Beating Cancer Starts with Finding It
Introducing GalleriTM
LDT Launched 2021
1
Required Blood Draws
43.1%
Positive Predictive Value (modeled)
51.5%
Sensitivity for All Cancers (Stages 1-3)1
50+
Cancers Detected
88.7%
Tissue of Origin Accuracy
99.5%
Specificity
1 Based on current trial status
In 2021, GRAIL published positive results from its Circulating Cell-free Genome Atlas (CCGA) study that enrolled more than 15,000 participants. The study found that Galleri reported sensitivity of 16.8%, 40.4% and 77.0% for stage I-III tumors, respectively, and 67.6% stage I-III sensitivity for the 12 deadliest cancers that account for approximately two-thirds of annual USA cancer deaths and 40.7% stage I-III sensitivity in all cancers. Further, Galleri was able to detect over 50 types of cancers across all stages, more than 45 of which do not have recommended screening in the US. And in 88.7% of the positive results, the test correctly identified the cancer signal of origin, or where the cancer originated from in the body – all with a low false positivity rate of less than 1%.
Galleri was introduced in 2021 as a laboratory developed test for early cancer detection. Galleri, which requires a prescription, is available initially through partner health systems, medical practices, and self-insured employers.
Meets Patient, Physician & Payor Needs
Screens for 50+ Cancers
Galleri can detect more than 50 cancers across all stages, of which 45 do not have recommended screening in the U.S. This 10x increase in the types of cancers that can be screened could help avert nearly 40% of the 5-year cancer mortality, or nearly 100,000 annual deaths in the U.S.1
Identifies More Early Stage Cancers
Without the use of blood-based testing, it is estimated only 31% of cancers are identified in stages 1 and 2, when they are most treatable. Based on analysis of GRAIL’s studies to date, this could increase to 82% with broad adoption of Galleri in addition to recommended single-cancer screening.2
Identifies Cancer Location to
Inform Next Steps
With 88.7% accuracy in identifying tissue of origin, this allows physicians to simplify their diagnostic workup and more rapidly determine the appropriate cancer treatment.
Improves Outcomes
Today, 71% of cancer-related deaths are in cancers with no recommended screening. With limited screening, cancer is more likely to be detected in late stages but when we diagnose cancer too late, less than 20% of patients will survive more than 5 years. In contrast, if we diagnose cancer early, approximately 90% of patients are expected to survive beyond five years.3
Up to 65% Reduction in Cost
Galleri has the potential to more efficiently identify cancers and reduce overall diagnostic workup costs.4 We estimate that ~44% of patients who are tested positive will have cancer. This represents a very significant step forward compared to today’s most commonly used screening tests, which often have a positive predictive value in the 3 to 5% range.
1 Clarke et al. Cancer Epidemiology, Biomarkers, & Prevention 2020
2 Modeled based on GRAIL’s recent data from ESMO 2019 and SEER cancer registry
3 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov)
4 Diagnostic workup cost estimates include downstream costs + initial screening test