BOSTON and CAMBRIDGE, England, December 2, 2015 /PRNewswire/ --
Evaluated prospectively in a 15-year, 200,000-subject clinical trial, the test addresses a high unmet need in women's health
Abcodia Ltd, a clinical stage company engaged in the commercial development of novel tests for the early detection of cancer, announced today the availability of the ROCA® Test for use by physicians in five U.S. states: Arizona, Illinois, Massachusetts, New Jersey and Texas. The test is already being used in the U.K. by private clinics and will become available in additional U.S. states throughout 2016.
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The ROCA Test, available as a service from Abcodia's testing laboratory, uses a number of clinical variables such as age, menopausal status and serial blood measurements of biomarker protein, CA-125 to assess the likelihood that a woman has ovarian cancer. The ROCA Test is the first step in a multimodal assessment for ovarian cancer and is to be used to help physicians assess whether a woman should undergo additional testing, including transvaginal ultrasound scan of the ovaries.
The ROCA Test is intended for post-menopausal women aged between 50 and 85, with no known ovarian cancer risk factors, or for women between 35 and 85, who are considered to be at high risk of ovarian cancer due to a family history of ovarian or breast cancer, or a mutation in specific genes such as the BRCA1 or BRCA2 or Lynch Syndrome genes.
An established body of evidence demonstrates the need for earlier diagnosis to improve outcomes in ovarian cancer. Studies show that 92% of women diagnosed at Stage 1 survive for five or more years, compared to only 18% of women diagnosed with Stage 4 disease.[i], [ii] Because ovarian cancer frequently has either vague or no symptoms, women are most commonly diagnosed with advanced Stage 3/4 disease. In the United States, three out of 10 women learn that they have ovarian cancer in an emergency care setting while being evaluated for an unrelated condition.
"Despite advances in treatment, ovarian cancer remains the fifth leading cause of cancer-related death among women in the U.S. There is a significant need for additional approaches to improve the way physicians detect ovarian cancer," said Nadia Altomare, president of Abcodia Inc. "We believe that a simple blood test like the ROCA Test fills a major unmet need in improving the early detection of ovarian cancer."
The ROCA Test, developed in Abcodia's CLIA-registered laboratory, is equivalent to the Risk of Ovarian Cancer Algorithm (ROCA) invented by Steven J. Skates, Ph.D., Associate Professor, Medicine, Harvard Medical School and Professor Ian Jacobs, President and Vice-Chancellor, University of New South Wales, Australia. ROCA has been evaluated in several prospective studies, the largest being the UK Collaborative Trial for Ovarian Cancer Screening (UKCTOCS) involving more than 200,000 women over 15 years. The latest results from this study, published in Journal of Clinical Oncology in May 2015 revealed that multimodal screening using ROCA as the first line test, triggering a transvaginal ultrasound scan as required, reported a sensitivity of 85.8% and specificity of 99.8% for detection of ovarian cancer.[iii] The sensitivity of ROCA compared favorably to the use of CA-125 alone, which would have identified only 41.3% to 66.5% of ovarian cancers (depending on the threshold value used). Further results from UKCTOCS, expected in December 2015, will determine whether multimodal screening initiated by ROCA reduces ovarian cancer mortality.
"Making the ROCA Test available in the U.S. through our CLIA-registered laboratory is a key milestone for us, and follows a successful launch and adoption by a number of leading clinicians in the U.K." said Julie Barnes, CEO of Abcodia. "After evaluation in the largest prospective trial ever conducted in this area, and amidst some encouraging results, Abcodia is proud to offer the ROCA test in the U.S."
Women living in Arizona, Illinois, Massachusetts, New Jersey and Texas can obtain the ROCA Test by downloading and completing an online request form, securing their physician's approval and having a blood sample collected by a healthcare professional. All testing is conducted in Abcodia's clinical laboratory in Memphis, Tenn. and final results are sent to a woman's physician. Initially, the ROCA Test will be available only on a self-pay basis while Abcodia establishes its reimbursement strategy through public and private payers.
About Abcodia
Abcodia Ltd is a clinical stage company engaged in the commercial development of novel tests for the early detection of cancer. The Company's first product is the ROCA Test for the early detection of ovarian cancer, and it is expanding its pipeline of early detection technologies for lung, colorectal and pancreatic cancer. Abcodia's offerings are based on expertise in measuring and modelling dynamic changes over time of clinical variables including test results from serum-based markers before cancer is clinically diagnosed, and it maintains exclusive commercial access to a biobank of five million serum samples donated from more than 200,000 individuals over a 10-year period. Abcodia holds strategic collaborations with leading global organizations including Cancer Research UK, University College London and other academic and industry partners.
Abcodia is a privately held company funded through investments from Albion Ventures, Cambridge Innovation Capital, Scottish Equity Partners and UCL Business. Headquartered in Cambridge, U.K., the Company has operations in Boston, Mass. and a clinical laboratory in Memphis, Tenn. For more information, visit http://www.abcodia.com/.
About the ROCA® Test
Abcodia's first product, the ROCA Test indicates a woman's likelihood of having ovarian cancer. The ROCA Test is intended for postmenopausal women aged between 50 and 85, or for certain women between 35 and 85 years of age who are considered to have a higher risk due to family history of ovarian or breast cancer or genetic mutations in, for example, the BRCA1 or BRCA2 genes. The ROCA test has been evaluated as part of a multimodal screening strategy in several prospective clinical trials in both the U.K. and U.S. involving more than 215,000 women over the past 15 years. The results of those studies show that the ROCA Test, when used with appropriate transvaginal ultrasound as the follow up test, has a higher performance than other currently available methods that have been evaluated prospectively in healthy women. In the clinical studies, the ROCA Test detects the majority of ovarian cancer cases before the first signs or symptoms of ovarian cancer appear.
The ROCA Test is CE marked and is currently available in the private healthcare market in the U.K. The ROCA Test became available as a service from Abcodia's testing laboratory, in select U.S. markets in December 2015, and it will become available in additional U.S. states throughout 2016. For more information, visit http://www.therocatest.co.uk or http://www.rocatest.com.
i. American Cancer Society. http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-survival-rates . Retrieved 11/5/15.
ii. Ovarian Cancer Research Fund: http://www.ocrf.org/about-ovarian-cancer/treatment-of-ovarian-cancer/staging-and-grading/stage-iv . Retrieved 11/5/15.
iii. Menon U, Ryan A, Kalsi J, et al. Risk Algorithm Using Serial Biomarker Measurements Doubles the Number of Screen-Detected Cancers Compared With a Single-Threshold Rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening. J Clin Oncol. 2015;33(18):2062-71
US MEDIA CONTACT: Danielle Lewis, Lazar Partners, T: +1-(212)843-0211, dlewis@lazarpartners.com
UK MEDIA CONTACT: Rozi Morris/Gemma Howe, Instinctif Partners, T: +44-(0)20-7457-2020, abcodia@instinctif.com
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