Abcodia announces initial US availability of ROCA® test to aid early detection of ovarian cancer
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 US states: Arizona, Illinois, Massachusetts, New Jersey and Texas. The test is already being used in the UK by private clinics and will become available in additional US states throughout 2016.
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. 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 US. 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.”
“Making the ROCA Test available in the US 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 UK” 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 US.”