FDA clears biomarker test for ovarian cancer

September 6, 2011 in Cancer

Approval last week by U.S. Food and Drug Administration (FDA) clears the path for nationwide use of tools that show the greatest specificity in estimating the risk of ovarian cancer in women with a pelvic mass.

The granted 510(k) clearance for marketing and use of a combination of blood tests for proteins HE4 and with the Risk of Ovarian Malignancy (ROMA). Research demonstrates that examining levels of HE4 and CA125 using the ROMA algorithm shows the highest in determining ovarian cancer risk in pre- and post-menopausal women.

The combination of blood tests and the ROMA algorithm were developed through the research of a team led by Richard G. Moore, MD, a gynecologic oncologist with the Program in Women's at Women & Infants Hospital of Rhode Island and director of the Center for Biomarkers and Emerging Technology. Dr. Moore is the lead author of a multi-center study investigating the use of HE4 and CA125 to determine ovarian .

"Using ROMA with HE4 and CA125 significantly improves our ability to identify women who are at high or low likelihood of ovarian cancer when they present with an ovarian cyst or mass," explained Dr. Moore, who is also an assistant professor of obstetrics and gynecology at The Warren Alpert Medical School of Brown University.

The CA125 test has been the gold standard for monitoring patients diagnosed with ovarian cancer. The test, however, is limited in its sensitivity and specificity as well as its ability to detect all types of ovarian cancer. HE4 has been shown to be elevated in epithelial ovarian cancers, the most common type of ovarian cancer, but not elevated in many benign gynecologic diseases. Combining physician assessment with the independently validated ROMA algorithm more accurately stratifies benign disease from ovarian cancer in women who present with a pelvic mass. It also enables physicians to identify those patients at high likelihood of who should have their surgery performed by a gynecologic oncologist.

"Patients who have ovarian cancer have better outcomes when their surgery is performed by a gynecologic oncologist at centers experienced in the management of this disease," Dr. Moore said. "This combination test will change the way doctors diagnose and treat ovarian cancer."

Ovarian cancer is called a "silent killer" because it is difficult to diagnose with symptoms that are easily confused with other non-cancerous conditions. Three quarters of ovarian cancer cases are diagnosed at an advanced state, when the disease is more difficult to treat. Of patients who are diagnosed early (Stage I-II), more than 90 percent will live past five years. However, only one quarter of cases are diagnosed in the early stages.

"Any test that can help to identify women at high risk of ovarian cancer so that they can receive the right care by the right physician has real-world clinical impact today," said Cornelius "Skip" Granai, MD, director of the Program in Women's Oncology. "It is especially exciting that this was developed as a result of research spearheaded by one of our doctors. Dr. Moore has spent years probing answers for women with ovarian cancer and it is a medical breakthrough to be able to help detect ovarian cancer during its early stages."

Clearance of ROMA as a risk-stratification tool is based on results of a prospective, double-blind, multicenter trial involving 472 women with pelvic mass who were scheduled for surgical intervention. Blood samples were obtained from these women to measure for levels of HE4 and CA125. Two separate algorithms for premenopausal and postmenopausal women stratified patients into low- and high-risk groups. All patients then underwent surgical removal of the pelvic mass, and if a patient was diagnosed with an epithelial ovarian cancer, surgical staging was required by protocol. All tissue specimens were examined to verify the diagnoses made by study site pathologists.

This research was presented at this year's annual meeting of the Society of Gynecologic Oncologists and published in the August 2011 issue of Obstetrics and Gynecology, the journal of the American Congress of Obstetricians and Gynecologists.

The combined HE4 and CA125 algorithm was found to be highly accurate in assigning patients to risk groups, with 95 percent of epithelial ovarian cancers correctly classified as high-risk.

"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 and enable those who are at risk to be referred to a gynecologic oncologist – a benefit that may improve treatment outcomes," said Paul Touhey, president and chief executive officer of Fujirebio Diagnostics, which manufactures the algorithm. "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."

Provided by Women & Infants Hospital

not rated yet  

Rank not rated yet
Relevant PhysicsForums posts

More news stories

Team finds mechanism linking key inflammatory marker to cancer

In a new study described in the journal Oncogene, researchers reveal how a key player in cell growth, immunity and the inflammatory response can be transformed into a primary contributor to tumor growth.

Cancer created 3 hours ago | popularity not rated yet | comments 0 | with audio podcast

Study of young Israelis emphasizes need for avoidance of sun exposure for the very young

A new study conducted using extensive medical records of over one million Israeli adolescents before military service shows clearly how exposure to the Israeli sun of young, light-skinned children increases substantially ...

Cancer created 5 hours ago | popularity not rated yet | comments 0

Genetic diversity within tumors predicts outcome in head and neck cancer

A new measure of the heterogeneity – the variety of genetic mutations – of cells within a tumor appears to predict treatment outcomes of patients with the most common type of head and neck cancer. In the May 20 issue ...

Cancer created 9 hours ago | popularity not rated yet | comments 0

Molecular marker from pancreatic 'juices' helps identify pancreatic cancer

Researchers at Mayo Clinic have developed a promising method to distinguish between pancreatic cancer and chronic pancreatitis—two disorders that are difficult to tell apart. A molecular marker obtained from pancreatic ...

Cancer created 9 hours ago | popularity not rated yet | comments 0

New smartphone application improves colonoscopy preparation

The use of a smartphone application significantly improves patients' preparation for a colonoscopy, according to new research presented today at Digestive Disease Week (DDW). The preparation process, which begins days in ...

Cancer created May 19, 2013 | popularity not rated yet | comments 0


First long-term study reveals link between childhood ADHD and obesity

A new study conducted by researchers at the Child Study Center at NYU Langone Medical Center found men diagnosed as children with attention-deficit/hyperactivity disorder (ADHD) were twice as likely to be obese in a 33-year ...

New study finds blind people have the potential to use their 'inner bat' to locate objects

New research from the University of Southampton has shown that blind and visually impaired people have the potential to use echolocation, similar to that used by bats and dolphins, to determine the location of an object.

Germ-fighting vaccine system makes great strides in delivery

A novel vaccine study from South Dakota State University (SDSU) will headline the groundbreaking research that will be unveiled at the American Association of Pharmaceutical Scientists' (AAPS) National Biotechnology Conference ...

Diabetes drug tested in Parkinson's disease patients

Parkinson's disease (PD) is a degenerative neurological disorder marked by a progressive loss of motor control. Despite intensive research, there are currently no approved therapies that have been demonstrated to alter the ...

Women with severe injuries are less likely than men to be treated in a trauma center

Women are less likely than men to receive care in a trauma center after severe injury, according to a new study of almost 100,000 Canadian patients.

Neurons that can multitask greatly enhance the brain's computational power, study finds

Over the past few decades, neuroscientists have made much progress in mapping the brain by deciphering the functions of individual neurons that perform very specific tasks, such as recognizing the location ...