Subject: FDA
Exact Sciences Presents Data On Blood-Based Test For Detection Of Hepatocellular Carcinoma, Earns FDA Breakthrough Device Designation
BOSTON, Nov. 8, 2019 /PRNewswire/ -- (NASDAQ: EXAS) ? A new study of 443 patients by Exact Sciences Corp. and its collaborators demonstrated 80% sensitivity at 90% specificity with a novel combination of six blood-based biomarkers for the most common type of liver cancer, hepatocellular carcinoma (HCC)i. The study also showed 71% sensitivity for early stage HCC at 90% specificity. The study compared performance to the alpha-fetoprotein (AFP) test, which demonstrated 45% sensitivity at 90% specificity for early stage HCC. Lead author Naga Chalasani, M.D., Associate Dean for Clinical Research at Indiana University School of Medicine and Director, Division of Gastroenterology and Hepatology, will present the findings Sunday, November 10th at the 2019 annual meeting for the American Association for the Study of Liver Diseases (AASLD) in Boston.
The data are included by AASLD's Scientific Program Committee in The Best of The Liver Meeting, a distinction that recognizes abstracts for their rigorous scientific methodology and key insights for patient care and ongoing research. Exact Sciences' HCC test has also been granted Breakthrough Device designation by the U.S. Food and Drug Administration. The agency's Breakthrough Devices program expedites development, assessment, and review processes to provide patients and health care providers with timely access to new technologies.
Liver cancer is the number four cancer killer globally, and more than 42,000 Americansii and 780,000 people worldwide are diagnosed with the disease each yeariii. HCC alone accounts for approximately 90% of primary liver cancersiv. Clinicians and patients need more accurate, convenient testing options to help combat rising incidence rates, which have more than tripled since 1980i.
Current guidelines recommend at-risk patients undergo testing every six months using ultrasound (US) with or without the AFP blood testv. Combined, US and AFP have demonstrated 63% sensitivity for early stage cancersvi. Nearly half of Medicare patients tested for HCC receive only the AFP testvii, which in Exact Sciences' Study was less sensitive for HCC detection than US and AFP combined. Three-year survival rates nearly double for patients who undergo regular testing compared to those who do not, yet fewer than one-third of patients adhere to current guidelinesv.
"A growing number of patients around the world are considered high risk for developing HCC," said Kevin Conroy, chairman and CEO of Exact Sciences. "A more sensitive and convenient blood-based test could help catch the disease earlier, which may lead to better outcomes. We are encouraged by the data presented at The Liver Meeting, as it shows an important advancement over the options currently available."
Exact Sciences' multi-center, case-control study analyzed 443 blood samples, including 135 HCC cases and 308 age- and liver disease etiology-matched controls. The accuracies of both Exact Sciences' HCC test and the AFP blood test were analyzed for all Barcelona Clinic Liver Cancer (BCLC) stages and for early stage HCC (stages 0 and A). With specificity set at 90%, Exact Sciences' four methylated DNA markers and two protein markers detected 80% of HCC cases across all stages. The test demonstrated 71% sensitivity for early stage HCC, outperforming the AFP test, which detected 45% of early stage cancers and 62% of cancers across all stages in Exact Sciences' study.
"There is a significant, worldwide unmet need for a blood-based, early detection diagnostic test for liver cancer in persons with elevated risk for the disease," said Dr. Chalasani. "The DNA methylation based liquid biopsy developed by Exact Sciences is timely and very promising for addressing this unmet demand."
Exact Sciences is finalizing its HCC test development and plans to make the test available in the second half of 2020. This will help generate real-world evidence to support guideline inclusion, broad reimbursement, and adoption of the test over time.
Note to editors: The full abstract (#109) can be found in the October 2019 supplement of Hepatology.
Media Contact:
Cara Connelly, [email protected], 614-302-5622
Investor Contact:
Megan Jones, [email protected], 608-535-8815
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Fueled by the success of Cologuard and Oncotype DX, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Alongside its visionary collaborators and in partnership with communities, Exact Sciences unites the best resources to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.
About the HCC test
The Exact Sciences HCC test is in development and not commercially available. The HCC test performance claims have not been established.
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i ACS. Cancer Facts & Figures 2019. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf. Accessed September 19, 2019.
ii National Institute of Health. NCI SEER Cancer Stat Facts: Liver and intrahepatic bile duct cancer. 2019. https://seer.cancer.gov/statfacts/html/livibd.html. Accessed October 30, 2019.
iii World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. 2018. Accessed October 30, 2019.
iv Llovet JM, et al. Nat Rev Dis Primers. 2016;2:16018
v Harris PS, Hansen RM, Gray ME, et al. Hepatocellular carcinoma surveillance: An evidence-based approach. World J Gastroenterol. 2019:25(13):1550-1559.
vi Tzartzeva, Kristina et al.?Gastroenterology. Volume 154, Issue 6, 1706 - 1718.e1
vii Davila, JA et al. Hepatology. 2010 July ; 52(1).
SOURCE EXACT SCIENCES CORP
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