Abcodia Announces Expanded U.S. Availability of the ROCA® Test for Early Ovarian Cancer Detection

BOSTON and CAMBRIDGE, England, January 26, 2016 /PRNewswire/ --

Abcodia, a commercial stage company focused on the development of proprietary tests for the early detection of cancer, today announced expanded U.S. availability of the ROCA® Test.

     (Logo: http://photos.prnewswire.com/prnh/20150512/743958 )

Following an initial U.S. launch in Arizona, Illinois, Massachusetts, New Jersey and Texas, the ROCA Test is now available in nine additional states (Georgia, Michigan, Missouri, North Carolina, Nevada, Ohio, Oregon, Virginia, Washington, Wisconsin) and the District of Columbia.

"We have seen strong interest in the recent data published in The Lancet, demonstrating that multi-modal screening with the ROCA Test can detect more ovarian cancers in the early stages of the disease and may reduce overall mortality by approximately 20 percent," said Nadia Altomare, CEO of Abcodia. "Over the coming year, we are committed to continued expansion in additional states and plan on further collaboration with health systems, healthcare providers, consumer advocacy groups, professional societies and industry thought leaders to educate patients and clinicians about the benefits of implementing a multimodal ovarian cancer screening strategy."

The ROCA Test fills a major unmet need in the early detection of ovarian cancer, which is the fifth leading cause of cancer-related death among women. Ovarian cancer is responsible for one death every 38 minutes and 14,000 deaths annually.^[i] Currently, however, there are no available tests with adequate combined sensitivity and specificity to reliably detect ovarian cancer at an early stage.

The ROCA Test has been evaluated as part of a multimodal screening strategy in several large-scale, prospective clinical trials in both the U.K. and U.S. Results from the UK Collaborative Trial for Ovarian Cancer Screening (UKCTOCS), a large prospective randomized controlled study of more than 200,000 women were recently published in The Lancet. These data suggested that inclusion of the ROCA Test in a multimodal screening strategy may reduce ovarian cancer mortality by an estimated 20 percent. In addition, the data demonstrated with high statistical significance that women in the ROCA Test group were detected with cancer at a much earlier stage than those who did not use the ROCA Test.^[ii]

Earlier data from the UKCTOCS study published in the Journal of Clinical Oncology showed that the ROCA Test, when used with transvaginal ultrasound (TVUS) as a follow-up test in postmenopausal women aged 50-85, had a sensitivity of 85.8 percent and a specificity of 99.8 percent, detecting twice as many ovarian cancer cases before the standard CA-125 test using a fixed threshold value.^[iii]

"The ROCA Test, used as part of a multimodal screening strategy, has been rigorously evaluated in prospective controlled trials and recent data from UKCTOCS study suggests that multimodal screening initiated by the ROCA Test can reduce mortality," noted Professor Ian Jacobs, President and Vice-Chancellor of University of New South Wales Australia, Honorary Professor at UCL and co-inventor of ROCA, who is also a Consultant and Non-Executive Director of Abcodia. "Further follow up in UKCTOCS will establish the extent of the mortality benefit achievable by screening using the ROCA Test. In the meantime, these results are valuable to women and doctors who are making an informed decision in clinical practice about whether to undergo ovarian cancer screening, and if so, which test to use."

Women living in eligible states can obtain the ROCA Test by completing an online test request form, securing their physician's approval and having a blood sample collected. All testing is conducted in Abcodia's clinical laboratory in Memphis, Tennessee, 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.

"The cumulative evidence from several peer-reviewed publications demonstrates that the ROCA Test is the test most likely to save lives. Furthermore, the ROCA Test has the highest sensitivity for detection of ovarian cancer, can detect more cancers at the early stages and, when used in conjunction with transvaginal ultrasound as the follow up test, has the lowest number of false positive results," said Julie Barnes, Ph.D., Chief Scientific Officer of Abcodia. "Women at risk for ovarian cancer, including those with established hereditary risk factors, now have an important new reason to consult with their gynecologist to make an informed decision about starting routine testing for ovarian cancer."

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. Recent data published in The Lancet suggest that annual multimodal screening for ovarian cancer using the ROCA Test may reduce mortality by approximately 20 percent.

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. Ovarian Cancer National Alliance: http://www.ovariancancer.org/about/statistics/ . Retrieved 11/4/15.

ii. Jacobs IJ, Menon U et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)01224-6/abstract . Accessed January 7, 2016

iii. Menon U, Ryan A, Kelsi J, Gentry-Maharaj A, Dawnay A, et al. (2015) A risk algorithm using serial biomarker measurements doubles the number of screen-detected cancers compared to a single threshold rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) J Clin Oncol; Epub ahead of print 10.1200/JCO.2014.59.4945

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SOURCE Abcodia Ltd