GRAIL Announces Partnership with Alignment Health Plan as First Medicare Advantage Plan to Offer Galleri® Multi-Cancer Early Detection Blood Test

Rhea-AI Summary

GRAIL, LLC has partnered with Alignment Health Plan to provide Medicare Advantage members in California and North Carolina access to Galleri®, a multi-cancer early detection blood test. Starting January 1, 2022, new and existing members can obtain the test, which detects over 50 cancers, many of which lack standard screenings. The initiative aims to enhance cancer detection among seniors, thereby potentially reducing late-stage diagnoses.

Positive

• Partnership with Alignment Health Plan expands access to Galleri test for Medicare Advantage members.
• Galleri can detect over 50 types of cancer with a low false positive rate of less than 1%.
• Early cancer detection can improve treatment outcomes and reduce the burden of late-stage cancer diagnoses.

Negative

• The Galleri test is prescription-only, which may limit accessibility for some patients.
• Not all cancers are detectable with Galleri, which may lead to a reliance on other screening tests.

--Health Plan Adopts Groundbreaking Cancer Detection Technology for Members in California and North Carolina--

MENLO PARK, Calif.--(BUSINESS WIRE)-- GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, announced today a partnership with Alignment Health Plan, a national Medicare Advantage health plan from Alignment Healthcare (NASDAQ: ALHC), to provide its Medicare Advantage members access to Galleri®, GRAIL’s groundbreaking multi-cancer early detection blood test. Based in Orange, California, Alignment Health Plan is the first Medicare Advantage plan to offer the Galleri test as a complement to recommended single cancer screenings.

“Providing innovative benefits to support the health and care needs of our members is what we do here at Alignment,” said Dawn Maroney, markets president, Alignment Healthcare, and CEO, Alignment Health Plan (CA). “Taking preventive measures before signs and symptoms appear is key to finding cancer early when it is most treatable. We are excited to partner with GRAIL to provide seniors the tools they need to proactively manage their health.”

New and existing Alignment Health Plan members who enroll in select HMO and PPO plans in California and North Carolina¹ will have access to Galleri beginning Jan. 1, 2022. Galleri is available by prescription only.

“GRAIL is thrilled to partner with Alignment Health Plan to offer our first-of-its-kind Galleri test to a population that by age alone has an elevated risk of developing cancer,” said Dr. Josh Ofman, president and chief medical officer at GRAIL. “Providing access to a technology that can detect cancer signals in the blood, even before symptoms appear, can help us decrease the burden of late-stage cancer diagnoses. We commend Alignment for its innovative and proactive approach to early cancer detection for Medicare Advantage members.”

In a clinical study, Galleri demonstrated the ability to detect more than 50 types of cancer, over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.

More than 600,000 people died from cancer last year in the United States, according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and (in high-risk adults) lung. In fact, about seven in ten cancer deaths have no recommended early detection screening.

About Galleri

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.

For more information about Galleri, visit www.galleri.com.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

About Alignment Healthcare

Alignment Healthcare is a consumer-centric platform delivering customized health care in the United States to seniors and those who need it most, the chronically ill and frail, through its Medicare Advantage plans. Alignment Healthcare provides partners and patients with customized care and service where they need it and when they need it, including clinical coordination, risk management and technology facilitation. Alignment Healthcare offers health plan options through Alignment Health Plan and also partners with select health plans to help deliver better benefits at lower costs.

Important Galleri Safety Information

Galleri is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False positive (a cancer signal detected when cancer is not present) and false negative (a cancer signal not detected when cancer is present) test results do occur. Galleri is prescription only.

Laboratory/Test Information

GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

¹ Benefits vary by plan. In 2022, the personalized health screening benefit through GRAIL will be offered to members of AVA (HMO) 026, AVA (HMO) 027, Balance (PPO) 006, ESRD Balance (HMO C-SNP) 033, and Platinum (HMO) 008 in California; and AVA (HMO POS) 003 and NC Premier (HMO) 001 in North Carolina.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211206005194/en/

For GRAIL:

Corporate Communications

Molly Johnson

pr@grail.com

Investor Relations

Alex Dobbin

ir@grail.com

For Alignment Healthcare:

Priya Shah

mPR, Inc. for Alignment Healthcare

alignment@mpublicrelations.com

Source: GRAIL, LLC

FAQ

What is the significance of the partnership between GRAIL and Alignment Health Plan?

The partnership allows Medicare Advantage members in California and North Carolina to access the Galleri multi-cancer early detection test, enhancing cancer detection efforts.

When will members be able to use the Galleri test?

Members can start using the Galleri test beginning January 1, 2022.

How many types of cancer can Galleri detect?

Galleri can detect over 50 types of cancer, many of which currently lack recommended screening tests.

What is the false positive rate of the Galleri test?

Galleri has a low false positive rate of less than 1%.

Which states are involved in this partnership offering the Galleri test?

The Galleri test will be available to members in California and North Carolina.