FDA Clears a Test for Ovarian Cancer

Sometimes, I like to republish press releases. Here's a recent one from the FDA regarding a test called OVA1 for ovarian cancer. The key statement in this press release is this: "OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures."

FDA Clears a Test for Ovarian Cancer
Test can help identify potential malignancies, guide surgical decisions

The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

“Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications,” said Jeffrey Shuren, M.D., J.D., acting director of the FDA’s Center for Devices and Radiological Health.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

FDA NEWS RELEASE
For Immediate Release: Sept. 11, 2009
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Click here to read this on the FDA page.

Increasing ovarian cancer awareness

It's great to see how some states are making some significant efforts to increase ovarian cancer awareness. So many people are unaware of ovarian cancer risk factors. Take a look at this CNN video clip showing state efforts to raise money and public awareness for ovarian cancer:

Is Breast Cancer a Different Disease in Young Women?

We often think of breast cancer as primarily being a disease that affects older individuals. However, there are many cases of young, healthy women developing breast cancer and most of them have positive genetic markers to genes like BRCA1 and BRCA2. These genes are currently implicated in the majority of inherited breast (and even ovarian) cancers.

When breast cancer hits a really young woman (say in her early 30's), is it an entirely different disease? This seems to be an area that causes confusion in the oncology community. In a recent CME-certified activity titled, "Breast Cancer in Women Under 40," Jeffrey Peppercorn, MD, MPH discusses this issue. He remarks how breast cancer in women under 40 are more likely to be:

• estrogen receptor-negative (or ER negative)
  
• higher grade
• HER2-positive

Plus, he indicates that "young African-American women are more likely to have triple-negative breast cancer (estrogen receptor–negative, progesterone receptor–negative, and HER2-negative)."

Advances in medical science are helping us understand the disease process of cancer as researchers explore different treatment options including chemotherapy, hormone therapy, radiation, and other modalities. With all these advances in medicine and technology, will we ever find a cure for breast cancer?

Speaking of breast cancer, one topic I don't think anyone really understands is the spontaneous regression of tumors (when tumors disappear by themselves). It's very rare, but it does occur. Miracle healings! One minute you're told you have a tumor, the next minute it's gone! Do modern day miracles still happen? I believe they do. Scientists have postulated various mechanisms by which tumors may disappear by themselves. One researcher lists these possible explanations: "immune mediation, tumor inhibition by growth factors and/or cytokines, induction of differentiation, hormonal mediation, elimination of a carcinogen, tumor necrosis and/or angiogenesis inhibition, psychologic factors, apoptosis and epigenetic mechanisms." The list doesn't include supernatural healings, but psychologic factors? I'm not so sure about that.

If we can gain a better understanding of why certain tumors may disappear by themselves, then this information may someday lead to a cure for cancer. I'd like to see more research on the topic of spontaneous regression.

The ACLU Sues Over Patents on Cancer Genes

CNN: "Patents on two human genes linked to breast and ovarian cancers are being challenged in court by the American Civil Liberties Union (ACLU), which argues that patenting pure genes is unconstitutional and hinders research for a cancer cure." According to the ACLU, "Myriad's patents give it exclusive right to perform diagnostic tests on the genes -- forcing other researchers to request permission from the company before they can take a look at BRCA1 and BRCA2."

What do you think about this?

Scientists are identifying more cancer genes all the time. We already know that several forms of breast and ovarian cancers are linked to specific genes (like BRCA1 and BRCA2) that can be detected through special genetic tests. Oncologists and geneticists often struggle with the ethical dilemmas that frequently complicate genetic testing. Image source: CNN