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The Difference Cancer Screening Can Make

(BPT) - When her husband of 30 years was diagnosed with cancer, Cindy wanted to learn as much as she could about new approaches to cancer screenings and care. During his treatments, Cindy spent time researching and decided to be proactive to take care of her health for her family. As a Cuban American, family means everything to Cindy, who has three children and two grandchildren.

There are currently only five recommended cancer screenings in the United States, including mammograms and colonoscopies.[1] Cancers without widespread screening recommendations represent 71% of all cancer diagnoses in the U.S. among individuals aged 50-79.[2] While early detection has been proven to significantly improve cancer survival rates and reduce the cost and complexity of cancer treatment,[3,4] most cancers are detected too late.

'After my husband's treatment, I wanted to be proactive, so we went to the doctor. And while we were there, he mentioned to us about the Galleri test. Even though I felt fine, my husband said 'just do the test.''

During her appointment Cindy's doctor ordered the Galleri® test which screens for a signal shared by multiple types of cancers through a single blood draw and can detect this signal even before symptoms appear. If a cancer signal is detected, the test can predict the tissue type or organ associated with the cancer signal with high accuracy to help guide diagnostic evaluation.

Early Detection is Key

Cindy was surprised when she received a cancer signal detected result since she had no symptoms. She saw a hematologist for diagnostic evaluation, and it was confirmed, via biopsy, that she had lymphoma. Lymphoma, a group of blood cancers that develops in the lymphatic system, is often aggressive and not detected until advanced stages.[5]

'I went to a hematologist, and he told me that I was one of the earliest stage patients that he's treated,' recalled Cindy. 'It's very rare to catch this type of cancer in the beginning, because there often aren't any symptoms.'

'I'm so happy that I'm able to still be with my family, still be strong, still be able to be around for my grandkids,' said Cindy.

Spreading the Word

After navigating their cancer journeys, Cindy and her husband want to help educate others on the importance of proactively taking care of your health, especially for those with increased risk of cancer.

'You know, this whole journey, it's not about us, it's about sharing this with others, so that others can benefit from it,' Cindy's husband emphasized.

Learn More

The Galleri test must be prescribed by a healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate ­specific antigen (PSA) test and/or cervical cancer screening. It is intended for use in adults with an elevated risk for cancer, such as those aged 50 or older.

The Galleri test does not detect a signal for all cancers, and not all cancers can be detected in the blood. False-positive and false-negative results do occur.

Based on a clinical study of people ages 50 to 79, around 1% are expected to receive a Cancer Signal Detected result, which includes predicted Cancer Signal Origin(s). After diagnostic evaluation, around 40% of people are expected to have a confirmed cancer diagnosis. The overall sensitivity in study participants with lymphoma cancer was 56.3% (27.3% for Stage I, 58.3% for Stage II, 71.7% for Stage III and 60.9% for Stage IV).

Learn more at Galleri.com.

Important 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.

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[1] US Preventive Services Task Force (USPSTF) recommended cancer screening tests, Grade A,B,C. cestaskforce.org/uspstf/topic_search_results.

[2] SEER Stat Database: Incidence -SEER 18 Regs Research Data, Nov 2017 Sub. Includes persons aged 50+ diagnosed 2006-2015. GRAIL, LLC. Data on File GA-2021-0065.

[3] Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

[4] Reddy SR, Broder MS, Chang E, et al. Cost of cancer management by stage at diagnosis among Medicare beneficiaries. Curr Med Res Opin. 2022;38(8):1285-1294. doi: 10.1080/03007995.2022.204 7536.

[5] National Cancer Institute. Cancer Types: Lymphoma. https://www.cancer.gov/types/lymphoma.

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