First-of-its-kind Galleri

^®

Multi-Cancer Early Detection blood test can screen for multiple cancers through a single blood draw.

DETROIT

and

MENLO PARK, Calif.


,


Sept. 22, 2022


/PRNewswire/ —

Henry Ford Health

, one of the nation’s leading academic medical centers recognized for excellence in clinical care, research and education, and

GRAIL, LLC

, a healthcare company whose mission is to detect cancer early when it can be cured, today announced Henry Ford Health as the first healthcare provider in

Michigan

to offer

Galleri

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, GRAIL’s Multi-Cancer Early Detection (MCED) blood test.

Henry Ford

is among an early group of healthcare providers in the U.S. to offer this MCED test.

“We are entering an era of unprecedented ability to detect cancer at its earliest stages, which may ultimately help save many lives,” said


Adnan Munkarah

, M.D.

, Chief Clinical Officer at Henry Ford Health. “Diagnosing and treating cancer at an earlier stage often leads to more favorable outcomes. We are excited to offer this MCED blood test, which research shows can detect a cancer signal shared across more than 50 types of cancer through a single blood draw.”

The Galleri test is intended for use in those who are at an elevated risk of cancer, such as individuals ages 50 or older. Some younger people may also have an elevated risk of cancer, which is why

Henry Ford

is making the Galleri test available to patients who are 22 years or older, have no history of cancer or have been cancer-free at least three years, and are not currently pregnant.

“We believe that multi-cancer early detection tests like Galleri are the new front on the war against cancer and will enable us to dramatically increase cancer detection from screening in the population, with the goal of improving public health,” said

Bob Ragusa

, Chief Executive Officer at GRAIL. “We are excited to work with Henry Ford Health in adding Galleri as a complement to U.S. guideline-recommended cancer screenings.”

Galleri MCED test can detect many cancers that are not commonly screened for today to allow for earlier treatment, and can be incorporated into a routine healthcare visit. If a cancer signal is found, the results can point to where in the body the cancer is coming from. This can help healthcare providers guide next steps.

“Routine cancer screenings remain essential for early detection,” said


Ben Movsas

, M.D.

, Medical Director of

Henry Ford Health Cancer

. “But a MCED blood test can be used in addition to guideline-recommended cancer screenings, such as mammography, colonoscopy, prostate-specific antigen or cervical cancer screening. In a clinical study, the test also detected some cancer types, such as pancreatic, ovarian and esophageal, that currently lack routine recommended screening guidelines. This can provide a way to detect cancers earlier that are often not detected until a later stage.”

All cells in the body release DNA into the bloodstream, but DNA from cancer cells is different from the DNA of healthy cells. The Galleri test looks at the DNA in a patient’s blood to determine if any of it may have come from cancer cells. In a

clinical study

, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, more than 45 of which lack recommended screening tests today. Final results from the first

PATHFINDER study

, an interventional study that examined how well an MCED test can be integrated into clinical practice, were presented at the European Society for Medical Oncology (ESMO) Congress 2022 and demonstrated Galleri’s performance was consistent with findings from previous observational and case-controlled studies, underscoring the potential real-world ability of Galleri to find more cancers in earlier stages.

“For many people, routine cancer screenings are a part of the regular care they receive from their primary care physician,” said


Dan Passerman

, D.O.

, Chair of

Family Medicine

at Henry Ford Health. “The ability to include this test in a routine visit, and to obtain actionable health information as a result, will help people protect their health in a very meaningful and convenient way.”

Because the test is not currently covered by insurance, the Galleri MCED test is an out-of-pocket cost. Patients may be eligible to participate in the interventional

PATHFINDER 2 study

, which is evaluating the implementation and performance of Galleri in a clinical care setting. The study is currently enrolling individuals who meet the eligibility requirements, which include:

• 50 years or older and receive care at Henry Ford Health.
• Have never been diagnosed with cancer or have been cancer-free at least three years.
• Are not participants in previous or ongoing GRAIL sponsored studies.

Henry Ford

team members and their dependents who are enrolled in a Health Alliance Plan (HAP) of

Michigan

insurance plan may be eligible for a test at no cost.

Galleri is available by physician order only. Those who may be interested in the Galleri test should consult with their

Henry Ford

primary care physician to determine whether the test is appropriate for them.

To learn more about the Galleri test at Henry Ford Health, visit

henryford.com/cancerbloodtest

.

Serving communities across

Michigan

and beyond, Henry Ford Health is committed to partnering with patients and members along their entire health journey. Henry Ford Health provides a full continuum of services – from primary and preventative care, to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other healthcare retail.

It is one of the nation’s leading academic medical centers, recognized for clinical excellence in cancer care, cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, and multi-organ transplants. Consistently ranked among the top five NIH-funded institutions in

Michigan

, Henry Ford Health engages in more than 2,000 research projects annually. Equally committed to educating the next generation of health professionals, Henry Ford Health trains more than 4,000 medical students, residents and fellows every year across 50+ accredited programs.

With more than 33,000 valued team members, Henry Ford Health is also among

Michigan’s

largest and most diverse employers, including nearly 6,000 physicians and researchers from the Henry Ford Medical Group, Henry Ford Physician Network and Jackson Health Network.

The health system is led by President and CEO

Robert G. Riney

and serves a growing number of customers across 250+ locations throughout

Michigan

including five acute care hospitals, two destination facilities for complex cancer and orthopedics and sports medicine care, three behavioral health facilities, primary care and urgent care centers.

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 subsidiary of Illumina, Inc. (NASDAQ: ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated

29 October 2021

.

For more information, visit

grail.com

.

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across 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

galleri.com

.

The Galleri test 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. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal 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. Rx only.

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.

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SOURCE Henry Ford Health