US Department of Veterans Affairs (District of Columbia)

Study Participants from Veteran Affairs Sites Include a Diverse Population With Toxic Exposure MENLO PARK, Calif., Oct. 23, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri® multi-cancer early detection (MCED) test in routine clinical settings. The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC). Overall, the cancer signal detection rate in this veteran cohort was 1.30% (37/2854 participants; 95% CI: 0.94% - 1.78%), which is consistent with other populations that have received the MCED test (0.88%1 and 0.95%2). Among the 37 participants with a Cancer Signal Detected (CSD) at the time of analysis, 28 completed 180 days of follow-up, and of these, 12 cancer diagnoses were confirmed. More than half of the cases were identified at early stages (I-III) and the most common cancer signal of origin prediction was lung cancer (7). A positive predictive value (PPV), meaning that the test accurately detects a signal for cancer in someone that has cancer, was 42.9%, which is consistent with PPVs from previous Galleri testing datasets.1,3 Additional cancers could be diagnosed during the remainder of the one-year follow-up period. "While today doctors screen individually for five specific cancers, nearly 70% of cancers have no recommended screening tests. With 50,000 veterans diagnosed with cancer every year, these initial findings from REFLECTION showing a consistent cancer signal detection rate among the veteran cohort suggest that when added to recommended screenings, MCED tests like Galleri may address an unmet medical need," said Charles Atwood, M.D., pulmonologist and lead researcher on the REFLECTION study at VA Pittsburgh. "We look forward to longer-term data that will provide veteran-reported experience with MCED testing and cancer outcomes that may provide additional insights for veterans with service-related toxic exposures." The REFLECTION study (NCT05205967) is a multi-center, prospective, non-interventional, cohort study designed to understand the real-world experience of Galleri in clinical settings. This initial analysis included data from seven VA sites with 180 days of post-test follow-up. A total of 2,924 veterans were enrolled in the study at the time of the analysis and 2,854 are analyzable in these initial study data. Within the veteran cohort with data, 70% of participants had been exposed to one or more toxic environmental or occupational hazards during their service, including open burn pits/airborne hazards, Gulf War-related exposures, Agent Orange, radiation and others. The study included recruitment of veterans aged ≥22 years. The mean age of the cohort was 60 years old and the cohort was 79% male. "With many veterans at elevated risk of developing cancer, the initial results from the REFLECTION study provide important insights into the impact of MCED testing to help transform early cancer detection in a real-world setting," said Josh Ofman, MD, MSHS, President at GRAIL. "We're honored to be working with the VA, the largest national integrated health system in the U.S., to evaluate how Galleri can screen for many of the deadliest cancers before they become symptomatic, when there may be more treatment options." About the REFLECTION Study REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 17,000 individuals who have opted to be screened with the Galleri, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri in clinical settings. Patients who have been prescribed the Galleri test as part of medical care by their healthcare provider will have the opportunity to consent for participation into this data collection study and will be actively followed for 12 months from the time of enrollment through data capture from electronic health records and periodic self-report questionnaires. About GRAIL, Inc. GRAIL, Inc. 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 using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. For more information, visit grail.com. 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 Laboratory/Test Information The GRAIL 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. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes. Forward Looking Statements This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of test performance , clinical study results, regulatory compliance, potential market opportunity, anticipated growth strategies, and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors discussed under the section entitled "Risk Factors" in the Quarterly Report on Form 10-Q for the period ended June 30, 2024 and in GRAIL's other filings with the U.S. Securities and Exchange Commission (the "SEC") . Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make. Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events. Footnotes: Schrag D et al. Lancet. 2023;402(10409):1251-1260. Westgate C et al. Poster presented at American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023, Chicago, IL. Klein et al. Ann Oncol. 2021;32(9):1167-1177. SOURCE GRAIL, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 18, 2024 /PRNewswire/ -- Legacy, the country's leading sperm testing and freezing company, and Posterity Health, the only virtual-first center of excellence for male reproductive health, today announced an industry-changing partnership to provide end-to-end male fertility and hormone health care. The partnership is designed to help men test, improve, and preserve their fertility, making personalized, holistic reproductive healthcare accessible across the United States. The hybrid care model offers easy at-home testing from Legacy and treatment through Posterity Health. The program is designed to provide one-stop-shopping for all male reproductive care: Through Legacy, patients can complete a baseline semen analysis to understand their sperm health and potential fertility outcomes. This can include advanced analyses such as DNA fragmentation testing. Posterity Health's male fertility specialists provide comprehensive male reproductive health care, including fertility work-ups, low-T management and sexual health care. These services are available via telehealth or in-person at one of the Posterity Health treatment hubs. Posterity Health can also provide vasectomies, vasectomy reversals, sperm extractions and other male reproductive procedures. Legacy makes it easy for vasectomy patients to access rapid sperm freezing via Legacy's mail-in kit. Similarly, patients completing a vasectomy reversal can complete post-procedure semen analyses from home. Legacy's multi-site sperm storage ensures that individuals can have their sperm safely preserved for the future. Meanwhile, Posterity's integrated Couple's Care model enables a digital connection to a female partner's healthcare provider, accelerating care. Patients with employer-provided fertility benefits can access these services through leading fertility benefits providers, and may receive full coverage. "Through this program, folks across the country will get access to more affordable, more convenient, and higher quality care," said Khaled Kteily, Legacy CEO. "Legacy's vision of making male fertility care a natural, routine part of every man's health journey aligns perfectly with Posterity Health's mission of making specialized male reproductive care accessible. More than 25,000 people have tested and frozen their sperm with Legacy, and we're proud to provide our personalized services to Posterity's clients, expanding the male fertility offering in the employer space. We can't wait to help even more people build their families." "Our vision is to provide every male with the knowledge, resources and support to optimize their reproductive health," says Dr. Barrett Cowan, Co-Founder and Chief Medical Officer of Posterity Health. "This partnership will extend our reach and allow males who obtain a Legacy test to have immediate access to male fertility specialists. This combined solution creates a unique, private and personalized experience for males and couples struggling to conceive. Working together we can help every couple find their best path to pregnancy, improve the overall health status of males and dramatically reduce the cost of care." About Legacy Founded at Harvard University in 2018, Legacy pioneered direct access to male fertility information as the only company that allows customers to complete semen analysis, DNA fragmentation analysis, STI testing, and sperm cryopreservation without leaving their homes. Legacy is the only digital fertility clinic to offer post-thaw analysis to ensure a client's sperm is viable for freezing, and multi-site storage to maximize the security of all samples. Currently available across the United States, Legacy's fertility solutions are trusted by leading health plans, employee benefits providers, and the US Department of Veterans Affairs. Through the Legacy website, consumers can access educational content, personalized fertility consultations, and other services that promote lifelong sperm health and wellness. To learn more about Legacy, visit givelegacy.com. About Posterity Health Posterity Health is the only virtual-first center of excellence for male reproductive health. We provide a hybrid care delivery model, allowing for telehealth appointments, ongoing treatment plans and in-person care powered by Posterity Health's Male Management Platform. Through innovative technologies, personalized care and expert guidance, Posterity Health empowers males to take control of their reproductive health. Learn more at posterityhealth.com. SOURCE Legacy WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Oct. 10, 2024 /PRNewswire/ -- Legacy, the leading provider of at-home sperm testing and freezing in the United States, is proud to announce the appointment of its newest strategic advisor: Dr. Brian Levine, an award-winning board-certified reproductive endocrinologist and the founding partner and Practice Director of CCRM Fertility New York and the founder of Nodal, the online surrogacy platform. Widely recognized as one the country's leading fertility experts, Dr. Levine has been named a Castle Connolly Top Doctor since 2019 and has been interviewed by The New Yorker and CNN on the latest fertility science. He was awarded the highest prize by the American Society of Reproductive Medicine for an assisted reproductive technology (ART) video on three-dimensional sperm imaging techniques. Dr. Levine attended New York University School of Medicine, where he recently completed a term on NYU's Board of Trustees. CCRM Fertility is a global pioneer in reproductive medicine, research and treatment, offering access to a network of award-winning fertility doctors, a full suite of reproductive services, innovative technologies and cutting-edge labs. Nodal is an innovative technology platform committed to revolutionizing the surrogacy and assisted reproduction sector. By offering secure, efficient, and transparent solutions, Nodal enables intended parents and surrogates to manage their surrogacy journeys with ease and confidence. "I am excited to join forces with Legacy as a strategic advisor," said Dr. Levine. "Over the last 15+ years, I have been devoted to normalizing an open dialogue about infertility, a disease that affects both men and women equally. Legacy's mission — to raise awareness about the global sperm decline and the importance of proactive sperm testing and freezing — aligns perfectly with mine." In his role as a strategic advisor, Dr. Levine will help guide Legacy in revolutionizing male fertility care. His expertise will be instrumental to the company's continued innovation and expansion. "We are delighted to welcome Dr. Brian Levine to the Legacy board of advisors, which includes some of the world's top fertility experts," said Khaled Kteily, CEO and founder of Legacy. "His dedication to advancing male reproductive health will make him a valuable partner as Legacy brings at-home sperm testing and freezing to the mainstream." The largest male fertility clinic in America, Legacy allows customers to test and cryopreserve their sperm without leaving home, serving over 25,0000 clients to date. Available across the United States, Legacy is trusted by leading health plans, employee benefits providers, and the U.S. Department of Veterans Affairs. In spring 2024, Legacy was named to the Financial Times' list of The Americas' Fastest-Growing Companies. To learn more about Legacy and its innovative at-home sperm testing and freezing, visit givelegacy.com. SOURCE Legacy WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED