Getlabs to Add GRAIL's GalleriⓇ Multi-Cancer Early Detection Test to Suite of At-Home Diagnostic Services

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Feb 15, 2024, 09:00 ET

MIAMI, Feb. 15, 2024 /PRNewswire/ -- Getlabs, the nationwide leader for at-home diagnostics, today announced that it will be adding GRAIL's Galleri^Ⓡ multi-cancer early detection test to its list of test offerings. Getlabs will facilitate the sample collection process for the Galleri test by bringing the convenience of at-home blood draws to patients, eliminating the need for visits to clinics and reducing barriers to testing.

The Galleri test is a significant advancement in multi-cancer early detection screening. By analyzing fragments of cell-free DNA (cfDNA) in a simple blood draw, the Galleri test can help you screen for many of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver and others. In fact, the 5-year survival rate across all cancers is 89% when cancer is found while it is still localized, but drops to 21% once it's spread.The current screening paradigm screens for one cancer at a time and only covers five cancers types in the U.S.: breast, colon, cervical, prostate, and, in high-risk adults, lung. This approach is insufficient in substantially reducing cancer-related deaths since it fails to cover the majority of cancers.

This collaboration aims to make early cancer detection more accessible to all, including those with limited access to healthcare facilities or facing logistical challenges, thereby addressing the shortcomings of the current screening paradigm.

"Partnering with GRAIL allows us to extend the reach of early cancer detection and make it even more convenient for patients to prioritize their health," said Kyle Michelson, CEO, Getlabs. "By leveraging our expertise in at-home diagnostic collections, we can greatly expand access to critical cancer screening services. Our partnership with GRAIL represents a step forward in saving lives through early cancer detection."

About Getlabs:
Getlabs is the nationwide leader for at-home diagnostics. Healthcare organizations use our technology platform to dispatch skilled medical specialists to their patients and collect labs, vitals, biometrics, and more. By partnering with Getlabs, providers can expand access to care, improve adherence, and make informed medical decisions remotely. Learn more

About Galleri®:
The Galleri multi-cancer early detection test is a proactive tool in finding cancer early. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells (unique "fingerprints") to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. 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 recommended for people over the age of 50, or those with an elevated risk for cancer due to genetics, family history, environmental exposure, or other risk factors.

For more information about Galleri, visit galleri.com.

*Editor's note: Sensitivity in study participants with –

Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).
Esophagus cancer 85.0% overall (12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV).
Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV).
Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV).

Important Galleri Safety Information
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 "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. Rx 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.

SOURCE Getlabs