FDA approves ovarian cancer diagnostic

The FDA has approved Fujirebio Diagnostics’ combination blood test to detect ovarian cancer in women with ovarian cysts.

The test combines measures of two biomarker proteins, HE4 and CA125, using an algorithm called ROMA, aiming to improve physicians’ ability to identify ovarian cancer in women suffering from an ovarian cyst or mass.

The combined method shows the highest accuracy in determining ovarian cancer risk in premenopausal and postmenopausal women and “will change the way doctors diagnose and treat ovarian cancer”, claims Dr Richard G Moore, lead developer of the test and ROMA, gynaecologic oncologist at the Women & Infants Hospital of Rhode Island and Director of the Center for Biomarkers and Emerging Technology.

The new equipment enables physicians to be specific in choosing how the patient should be treated.

Dr Moore said: “Having women triaged to the right surgeons is very important. It gives them a survival advantage.”

“Patients who have ovarian cancer have better outcomes when their surgery is performed by a gynaecologic oncologist at centres experienced in the management of this disease,” he added.

Until now, the CA125 test has been the best method for monitoring patients with ovarian cancer. But the test is limited in its sensitivity and accuracy as well as its ability to detect every type of ovarian cancer. The HE4 protein has been shown to be higher in epithelial ovarian cancers, which is the most common type of ovarian cancer.

Combining these techniques with the ROMA algorithm enables the physician to differentiate between benign diseases and ovarian cancer in women who experience a pelvic mass.

Paul Touhey, President and CEO of Fujirebio Diagnostics, commented: “The ROMA test, by improving the sensitivity and specificity of methods to stratify patients with ovarian cancer, is expected to help thousands of women determine their risk for ovarian cancer and enable those who are at risk to be referred to a gynaecologic oncologist – a benefit that may improve treatment outcomes.”

“With this increased ability to improve referral patterns, as well as a price that is comparable to CA125 testing, the health care costs involved with cancer diagnosis and treatment should decrease significantly.”