Research Finds Talc Doesn’t Cause Cancer; Juries Disagree

Two lawsuits ended in jury verdicts worth $127 million. Two others were tossed out by a judge who said there wasn’t reliable evidence that the talc in Johnson & Johnson’s iconic baby powder causes ovarian cancer. So who’s right? And is baby powder safe?

Most research finds no link or a weak one between ovarian cancer and using baby powder for feminine hygiene, a practice generations of American mothers have passed on to their daughters. Most major health groups have declared talc harmless. Johnson & Johnson, whose baby powder dominates the market, says it’s perfectly safe.

Yet some 2,000 women have sued, and lawyers are reviewing thousands of other potential cases, most generated by ads touting the two big verdicts. Meanwhile, jury selection in the next trial began Monday.

A look at the issue:

WHAT IS TALC?

Talc is a mineral that is mined from deposits around the world, including the U.S. The softest of minerals, it’s crushed into a white powder. It’s been widely used in cosmetics and other personal care products to absorb moisture since at least 1894, when Johnson & Johnson’s Baby Powder was launched. But it’s mainly used in a variety of other products, including paint and plastics.

DOES IT CAUSE OVARIAN CANCER?

Like many questions in science, there’s no definitive answer. Finding the cause of cancer is difficult. It would be unethical to do the best kind of study, asking a group of women to use talcum powder on their genitals and wait to see if it causes cancer, while comparing them to a group who didn’t use it.

While ovarian cancer is often fatal, it’s relatively rare. It accounts for only about 22,000 of the 1.7 million new cases of cancer expected to be diagnosed in the United States this year.

Factors that are known to increase a women’s risk of ovarian cancer include age, obesity, use of estrogen therapy after menopause, not having any children, certain genetic mutations and personal or family history of breast or ovarian cancer.

WHAT RESEARCH CAN BE DONE

Two other kinds of research are possible. Neither of them, though, can conclusively prove something causes cancer. One looks back in time, after an illness has occurred. It compares two groups of people, one with the illness, one without, and asks about past exposures that might be factors. But people have trouble remembering details years later.

The second approach follows a large group of people. It assesses their health at the start and follows them for years, recording any illnesses while tracking possible influences such as diet and use of medication, alcohol or other substances. Scientists generally find these “prospective” studies most reliable.

WHAT RESEARCH SHOWS

The biggest prospective studies have found no link between talcum powder applied to the genitals and ovarian cancer. But about two dozen smaller, look-back studies over three decades have mostly found a modest connection – a 20 percent to 40 percent increased risk among talc users.

However, that doesn’t mean talc causes cancer. Several factors make that unlikely and there’s no proof talc, which doesn’t interact with chemicals or cells, can travel up the reproductive tract, enter the ovaries and then trigger cancer.

One large study published in June that followed 51,000 sisters of breast cancer patients found genital talc users had a reduced risk of ovarian cancer, 27 percent lower than in nonusers. An analysis of two huge, long-running U.S. studies, the Women’s Health Initiative and the Nurses’ Health Study, showed no increased risk of ovarian cancer in talc users.

WHAT EXPERTS SAY

If there were a true link, Dr. Hal C. Lawrence III says large studies that tracked women’s health for years would have verified results of the smaller look-back ones.

“Lord knows, with the amount of powder that’s been applied to babies’ bottoms, we would’ve seen something” if talc caused cancer, said Lawrence, vice president of the American College of Obstetrics and Gynecology.

The National Cancer Institute’s Dr. Nicolas Wentzensen says the federal agency’s position is that there’s not a clear connection.

“It is very hard to establish causal relationships,” he said, adding, “A lot of ovarian cancers occur in women who have never used talc, and many women have used talc and not gotten ovarian cancer.”

Research director Elizabeth Ward of the American Cancer Society says it is unusual to have so much discrepancy between studies. “The risk for any individual woman, if there is one, is probably very small,” Ward said.

WHAT LAWYERS AND COURTS SAY

Like the studies, courts have produced mixed results.

In the first trial two years ago, a South Dakota jury found Johnson & Johnson liable for one woman’s ovarian cancer but didn’t award any damages. This year, state court juries in St. Louis awarded plaintiffs $72 million and $55 million – verdicts the company is appealing.

But U.S. District Judge Nelson Johnson in Atlantic City threw out the first two of the 400 lawsuits in his court. He reviewed the research and testimony from two doctors who are the plaintiffs’ key expert witnesses and concluded the two aren’t reliable, noting they had previously written that there was no proof talc causes ovarian cancer. Other courts approved them as experts, noted the plaintiffs’ attorney, Ted Meadows of Montgomery, Alabama.

J&J attorney John Beisner says the health care giant plans to fight every lawsuit, rather than settle, “for the fundamental reason that the science on which they’re based is totally lacking.”

Most of the pending cases are in Missouri, California and New Jersey, where J&J is based.

In the case that began Monday in St. Louis, lawyers for Deborah Giannecchini of Modesto, California, say she was diagnosed with ovarian cancer in 2012 after years of talcum use. Her lawsuit accuses the company of “negligent conduct” in making and marketing its talc.

To view this entire article on AP.org, please click here.

Some Good News on Ovarian Cancer

The death rate from ovarian cancer declined in the United States by 16 percent from 2002 to 2012, among the largest reductions in the world.

The rate in the United States, 4.85 per 100,000, puts it roughly in the middle of a list of 47 countries whose rates and trends were described recently in a study in Annals of Oncology.

The countries with the lowest ovarian cancer mortality rates are Brazil, Hong Kong and South Korea, and those with the highest are Lithuania, Ireland and Latvia. Norway, Sweden, Denmark and Finland have rates higher than the United States, as does the European Union as a whole.

Still, all European countries except Bulgaria showed declines, and the rate in the European Union fell 9.9 percent over the period.

Most of the decline, the authors write, is attributable to the use of oral contraceptives, which offer long-term protection against ovarian cancer, and to the reduced use of menopausal hormone therapy after it was found to increase rates of cancer and cardiovascular disease.

Treatment of ovarian cancer has improved, too, but not significantly enough to explain these reductions. Most advances in treatment have been limited to germ cell tumors, which account for less than 10 percent of ovarian cancers.

In the United States and Britain, where oral contraceptive use began earlier and was more widespread, rates were substantially lower among women 70 to 79 — that is, those in the first generation that widely used the birth control pill. This is significant, according to the senior author, Carlo La Vecchia, a professor of epidemiology at the University of Milan.

“Women who use oral contraceptives longer than five years when they were young,” he said, “have a substantially reduced risk of ovarian cancer even when they are in middle age and older.”

To read this full article on The New York Times, please click here.

New Ovarian Cancer Test Promises More Accurate Survival Prognosis

A new computerised test originally designed to study plants is being used to accurately predict how long women suffering from ovarian cancer are likely to survive.

The fully automated system, which can analyse thousands of cells in only a few seconds, measures the diversity of different types of cell in areas of the body where the cancer has spread.

Scientists at the Institute of Cancer Research found a “staggering” difference in survival rates between women with high and low levels of diversity at these secondary sites.

Survival was far poorer among women with high diversity than those with low scores, with just nine per cent of women with diverse metastases surviving five years from diagnosis, compared with 42 per cent of those whose metastases were dominated by one cell type.

The test promises a far more sophisticated prognosis for women with the disease than is currently available, allowing those at high risk to be fast-tracked for aggressive treatment.

Currently doctors rely heavily on the overall size of cancerous tumours to indicate the how treatable the disease might be in a given patient.

The new test, however, will give clinicians a greater chance of recognising tumours which, while physically small, are located in areas of the body with a higher cell diversity, thereby making them more dangerous.

Dr Yinyin Yuan, who led the research, said: “We used to think of tumours as simply a collection of cancer cells, but we now know that they are often complex ecosystems made up of different types of healthy cell too.

“More work is needed to refine our test and move it into the clinic, but in future it could be used to identify women with especially aggressive ovarian cancers, so they can be treated with the best possible therapies available on the NHS or through clinical trials.”

Around 7,100 women are diagnosed with ovarian cancer each year in the UK.

Professor Paul Workman, chief executive of the Institute of Cancer Research said the deal was more likely to spread than many other cancers because there is no barrier between the ovaries and many of the bodies organs.

“Finding ways of treating highly aggressive ovarian cancers is a huge challenge,” he said.

“But by knowing that a woman has an especially lethal form of the disease, we can look to explore aggressive combination treatments, and give women choices about the kinds of care they want to receive.”

To read this full article on The Telegraph, please click here.

Trial Shows Personalised Medicine Benefit In Cancer Patients

A clinical trial involving patients with advanced cancers is the first of its kind to show the benefit precision medicine can have on delaying tumour recurrence.

Data from the Paris-based MOSCATO-01 study, presented at the Molecular Analysis for Personalised Therapy (MAP) conference, show that patients with advanced cancer who had their treatment tailored to their genetic makeup had around 30 percent longer before their cancer started growing again compared to the progression-free survival observed with previous treatments.

Patients taking part in the trial had a wide range of solid tumours (lung, breast, head and neck, genito-urinary, gastro-intestinal, and a variety of rare cancers), and all had already tried at least three cancer therapies. The researchers identified 411 patients with an actionable target, and 199 were treated with an ad hoc targeted therapy.

“The primary objective of the MOSCATO trial was to demonstrate that incorporating high-throughput gene sequencing and using it to make therapeutic decisions could improve the clinical outcome for at least 25 percent of advanced/metastatic cancer patients. Final results showed that 33 percent of patients had an improved survival,” said Professor Jean Charles Soria, principal investigator of the trial from the Gustave Roussy Cancer Campus.

“This is the first demonstration that comprehensive genomic analysis could improve the clinical outcome for cancer patients,” he noted.

“This positive result is particularly remarkable because the MOSCATO trial specifically excluded patients with well-established actionable targets for which approved and marketed targeted drugs are available (i.e. lung cancer with EGFR mutation, or ALK translocation, B-RAF mutant melanoma, GIST with KIT mutations or breast cancer with HER2 amplification),” added Professor Fabrice André, Head of the INSERM U981 research laboratory, and co-designer of the trial.

The MAP conference is a joint initiative between Cancer Research UK, UNICANCER and ESM.

“This is an exciting time for precision medicine and personalised treatment,” said Dr Rowena Sharpe, head of precision medicine at Cancer Research UK. “It’s fantastic to see continued effort going into this area and it’s important that we make the most of the data that we already have.”

To read the full article on PharmaTimes.com, click here.

FDA Grants Fast Track Designation To Niraparib For Ovarian Cancer

The FDA granted fast track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer, according to the drug’s manufacturer.

Niraparib is an oral, once-daily PARP inhibitor that is being evaluated in four ongoing clinical trials.

Data from the phase 3 NOVA trial — designed to evaluate niraparib (MK-4827, Tesaro) in more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy — will be presented in October at the European Society for Medical Oncology Congress in Copenhagen, Denmark.

The agent also is under evaluation as a first-line treatment for ovarian cancer, as well as for the treatment of patients with BRCA–positive breast cancer. Other trials are evaluating niraparib in combination with pembrolizumab (Keytruda, Merck) and bevacizumab (Avastin, Genentech).

Tesaro initiated a rolling submission of a new drug application for niraparib to the FDA, and the submission should be complete by the fourth quarter of this year, according to a company-issued press release.

“The initiation of this rolling NDA submission is a significant milestone for Tesaro, and we are committed to working collaboratively with the FDA to advance the review of the niraparib application,” Mary Lynne Hedley, PhD, president and chief operation officer of TESARO, said in the press release.

To read this article on Healio.com, please click here.

BET Inhibitor Tamps Down PD-L1 Activity In Ovarian Cancer Cells

Wistar Institute scientists have found a class of drugs that effectively dampened PD-L1 activity in ovarian cancer, even though it does not directly target PD-L1. Called bromodomain and extraterminal domain (BET) inhibitors, multiple candidates are in clinical trials for other cancers.

The interaction between the PD-1 protein and its ligand, PD-L1, blocks T cells from fighting tumor growth. But antibody-based drugs that disrupt this interaction can cause immune-related side effects, the scientists said in a statement.

“We wanted to explore anti-PD-L1 therapies specifically for ovarian cancer, but we also wanted to determine if other drugs that did not cause these negative anti-PD-L1 antibody-related side effects could be used to target this cancer-promoting pathway,” said Rugang Zhang, lead author of the study and a professor at the Wistar Institute.

They came upon BET inhibitors in their search for small molecule inhibitors, which inhibit cancer progression by targeting cells with cancer-associated mutations or proteins without harming healthy cells. They tested the BET inhibitor JQ1 in epithelial ovarian cancer cell lines and found it effectively suppressed PD-L1 activity and tamped down inflammatory responses, according to the statement.

While BET inhibitors do not specifically target PD-1/PD-L1, they work because the BET protein BRD4 regulates the expression of PD-L1, the researchers said. In ovarian cancer, cells tend to express higher levels of the BRD4 gene, so it could also be used as a biomarker to select patients who could benefit from treatment with BET inhibitors.

Merck markets the PD-1 drug Keytruda, while Bristol-Myers Squibb markets Opdivo. In July, Pfizer and Merck KGaA kicked off a Phase III trial combining a PD-L1 drug and platinum-based chemotherapy in epithelial ovarian cancer. Meanwhile, BET inhibitors are in clinical trials for various cancers, including hematologic malignancies and NUT midline carcinoma.

To view this entire article on FierceBiotech.com, please click here.

Want A BRCA Test? Some Insurers Require Genetic Counseling First

Health care providers and insurers agree that it’s in everyone’s best interest to refer women for genetic testing if their family history of breast or ovarian cancer puts them at higher risk. What they don’t agree on is what should happen before testing — whether women need to be advised by a certified genetic counselor or someone with similar training before the test is ordered.

On one hand, obstetrician-gynecologists say that counseling patients about hereditary cancers of the breast, ovaries, uterus and other reproductive organs is part of their normal routine, as is counseling pregnant patients about prenatal genetic testing. As licensed physicians, OB-GYNs are considered competent to provide this type of care.

“This is what we do,” said Dr. Mark DeFrancesco, the immediate past president of the American Congress of Obstetricians and Gynecologists, noting that most physicians have been taking family histories since medical school. “There are simple-to-understand criteria for who should be considered for genetic testing, and it usually has to do with whether you or someone in your family has had cancer.”

DeFrancesco recalled a patient whose mother, grandmother and maternal aunt all had breast cancer — but the insurer required she see a genetic counselor before testing would be approved.

In such cases, “it will take a few extra weeks to get tested, and she might decide not to bother,” he said.

DeFrancesco said genetic counselors have an important role to play after testing has been done to help patients who test positive for a genetic mutation understand the results.

In a statement released last December, the physicians group said it opposed such restrictions by insurers and warned that the requirement limits some patients’ access to care.

But insurers sometimes take a different view, although their rules vary. Two national insurers, UnitedHealthcare and Cigna, for example, require women to receive counseling by a certified genetic counselor or other professional trained in cancer genetics before they will approve coverage for tests that look for harmful irregularities in BRCA1 and BRCA2, the two genes most commonly linked to an increased risk for cancers of the breast, ovaries and some other organs.

UnitedHealthcare began requiring genetic counseling for BRCA tests in January. The insurer allows physicians to do the counseling themselves if they attest to being qualified to do so, said Dr. Lee Newcomer, senior vice president for oncology and genetics.

In 2013, Cigna made independent counseling by counselors unaffiliated with the testing lab a requirement for any patient getting a genetic test for BRCA mutations or for inherited mutations linked to colorectal cancers or a heart condition called Long-QT. Last July, the company expanded the list to include all hereditary cancers.

Cigna generally requires physicians to get additional training in cancer genetics to meet its counseling requirement, said Dr. Jeffrey Hankoff, Cigna’s medical officer for clinical performance and quality.

BRCA mutations increase a woman’s risk of developing breast cancer by age 70 by between 45 and 65 percent, the evidence suggests. Mutations in these two genes are thought to account for about 5 to 10 percent of all breast cancers and raise a woman’s risk of develping ovarian and other cancers, as well.

There are other particular genetic mutations known to increase the risk for breast and ovarian cancers, but they are less commonly tested for.

The U.S. Preventive Services Task Force, an independent panel of medical experts, recommends that women with a family history of breast, ovarian, fallopian tube or peritoneal cancer be screened to determine whether they are at increased risk for BRCA mutations and be referred for genetic counseling and testing, if that’s indicated.

Under the Affordable Care Act, women with insurance aren’t responsible for paying anything out of pocket for the testing and counseling recommended by the task force if it is performed by in-network providers.

The health law coverage requirement didn’t drive Cigna’s BRCA genetic counseling decision, said Hankoff.

“We had concerns that people were having testing ordered that didn’t appear to need it and probably didn’t understand it,” Hankoff said. In addition, “Too often the wrong tests were being ordered.”

For example, a woman whose sister has been diagnosed with breast cancer and tested positive for a specific mutation doesn’t need a genetic test that looks for all hereditary breast cancer mutations, Hankoff said. She only needs to be tested for the specific mutation that her sister has.

Genetic counselors, meanwhile, try to walk a middle line in the debate. To become certified, people complete a master’s degree program that encompasses both classroom study and clinical training in, among other things, genetics, ethics and the psychosocial aspects of helping families through diagnosis and the decision-making process. Certification by the American Board of Genetic Counseling is typically required to practice.

“There are a lot of complexities with genetic testing,” said Mary Freivogel, president-elect of the National Society of Genetic Counselors, who practices in the Denver area. “A lot of [OB-GYNs] don’t have the time or interest to do this well.”

With the number of genetic tests growing by leaps and bounds, meeting the demand for counseling can be a challenge, many in the cancer field agree.

And physicians don’t necessarily get it right. For one thing, said Robert Smith, a cancer epidemiologist who is vice president for cancer screening at the American Cancer Society, they often aren’t great at taking family histories, neglecting to gather information about male relatives, for example. Or they don’t factor in close relatives who died at a young age.

“Not everybody has a set of family members that allow for the elevated risk to be obvious,” Smith said. “There’s a lot to be said for having a specialist do it.”

To read this full article on NPR.org, please click here.

The Pill Health Benefits: Oral Contraceptive Use Has Driven Down Ovarian Cancer Death Rates Around The World

The birth control pill has not only granted women greater reproductive freedom, it may have also protected them against dying from ovarian cancer, suggests a new study published Tuesday in the Annals of Oncology.

Researchers analyzed trends in ovarian cancer death rates across more than 30 different countries, including the United States, between 1970 to 2012. Reaffirming previous research, they found a consistent decline in death rates throughout the decades, one still evident into the new century. For instance, the age-standardized death rate in the U.S. was 5.76 deaths per every 100,000 women in 2002, which fell 16 percent to 4.85 deaths per every 100,000 women by 2012, making it the biggest relative decline during that time period. The researchers concluded that the increase in oral contraceptive use worldwide was the main reason for this decline, especially since the largest declines were seen in particular groups of women.

“The falls were greater in young and middle-aged women than in the elderly, and earlier and larger in the USA, the UK and northern Europe,” the authors wrote. “These are the countries where oral contraceptives — which have a long-term protective effect on ovarian cancer risk — were introduced earlier and used more frequently.”

Other contributing factors for the decline included the decreased use of hormone replacement therapy (HRT), as well as medical advances in diagnosing and treating cases of ovarian cancer, particularly in wealthier countries.

“Women in countries such as Germany, the UK and the USA were also more likely to use hormone replacement therapy to manage menopausal symptoms than in some other countries,” said study co-author Dr. Eva Negri, Head of Epidemiologic Methods at the IRCCS Istituto di Ricerche Farmacologiche Mario Negri in Milan, Italy, in a statement. “The use of HRT declined after the report from the Women’s Health Initiative in 2002 highlighted the increased risk of cardiovascular disease, as well as breast and ovarian cancer, and so this may also help to explain the fall in death rates among middle-aged and older women in these countries.”

Although Japan and other Asian countries had the lowest overall death rates from ovarian cancer, largely because of their healthier diets, they also saw the smallest declines.

“Japan, where deaths from ovarian cancer have traditionally been low, now has higher rates in the young than the USA or the EU — again, reflecting infrequent oral contraceptive use,” explained lead author Professor Carlo La Vecchia of the University of Milan in Italy.

The researchers also used their collected data to predict death rates in these countries up until 2020, estimating that the U.S. will see a further decline of 15 percent whereas countries in the European Union and Japan will see a 10 percent decline.

Encouraging as this news is, the researchers are cautious to note that keeping cancer death rates down will require more than one strategy. In other words, while Japanese women could undoubtedly benefit from wider adoption of the pill, American women could follow in their example and adopt healthier diets.

To view the full article on Medical Daily, please click here.

Anti-Tumor Immunity Identified With New Ovarian Cancer Treatment Strategy

Few effective treatments have been approved to treat ovarian cancer, the deadliest of all cancers affecting the female reproductive system. Now, new research from The Wistar Institute demonstrates how a drug already in clinical trials could be used to boost anti-tumor immunity and cause T-cells to target the cancer directly while minimizing side effects. The results were published in the journal Cell Reports.

There has been considerable interest in the programmed cell death-1 (PD-1) protein and its ligand (PD-L1) because the interaction between the two inhibits important T-cell activity aimed at stopping tumor growth. PD-L1 is expressed on the surface of both cancer cells and immune cells across many different cancer types. Antibody-based drugs that specifically halt this interaction have shown promising results, though patients have experienced immune-related side effects as a result.

“We wanted to explore anti-PD-L1 therapies specifically for ovarian cancer, but we also wanted to determine if other drugs that did not cause these negative anti-PD-L1 antibody-related side effects could be used to target this cancer-promoting pathway,” said Rugang Zhang, Ph.D., professor and co-program leader in the Gene Expression and Regulation program at The Wistar Institute and lead author of the study.

Zhang and his team decided to screen for small molecule inhibitors that could be used as a treatment option. Small molecule inhibitors are a preferable form of cancer treatment because they block cancer progression by targeting cells that have proteins or mutations associated with cancer while sparing normal, healthy cells.

The researchers found that a class of drugs known as bromodomain and extraterminal domain (BET) inhibitors were particularly effective at suppressing PD-L1 activity when they studied the drug in epithelial ovarian cancer cell lines. Multiple BET inhibitors are in various stages of clinical trials for different types of cancer. They are able to suppress inflammatory responses, and they may be able to do so without affecting the anti-tumor immune response. In this study, they used an experimental BET inhibitor called JQ1.

Even though BET inhibitors do not specifically target PD-L1, the researchers were able to determine why this class of drugs is so effective. They showed that bromodomain-containing protein 4 (BRD4), one of the members of the BET family that is inhibited by these drugs, is a critical regulator of PD-L1 expression. The BRD4 gene is often amplified in ovarian cancer and may serve as a valuable biomarker to determine which ovarian cancer patients could benefit the most from receiving treatment with BET inhibitors.

“Targeting PD-L1 appears to be an effective strategy for combating a variety of human cancers,” said Hengrui Zhu, Ph.D., a postdoctoral fellow in the Zhang lab and first author of the study. “With BET inhibitors, we believe we have found a powerful new addition to available therapeutic strategies for ovarian cancer.”

To read the full article on MedicalXpress.com, please click here.

 

How Can A Company Market An Ovarian Cancer Screening Test If The FDA Says Women Shouldn’t Use It?

It is fitting that a Food and Drug Administration alert this week about tests marketed for ovarian cancer screening came out in September, which President Bill Clinton declared in 1998 to be National Ovarian Cancer Awareness Month.

The FDA’s “safety communication” warned that no currently available test is accurate and reliable for screening women who don’t have symptoms of ovarian cancer. That helps explain why, according to the American Cancer Society, ovarian cancer represents  only 3% of all malignancies in U.S. women but causes more deaths than any other cancer of the female reproductive tract. In the United States this year, 22,280 women will receive an ovarian cancer diagnosis and 14,240 women will die of it, the cancer society estimates.

The ovaries present a screening challenge because, situated in the pelvis, they’re not as accessible as, say, the breast or the cervix, both of which, of course, have cancer screening tests, and ovarian cancer symptoms usually don’t occur until the disease has metastasized. Even when symptoms do crop up–bloating, discomfort in the pelvis, quickly feeling full when eating, frequent urination–ovarian cancer typically isn’t the first thing that comes to women’s and doctor’s minds.

Only about 15% of ovarian cancers are detected early, before they have spread beyond the ovary. When the disease is found at that stage, about 94% of patients live at least five years after their diagnosis, according to the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program, or SEER.

Overall, though, fewer than half–only about 46%–of women with ovarian cancer live that long after diagnosis, according to SEER. That’s because 60% of ovarian cancers have already spread to distant parts of the body by the time they’re diagnosed. Women diagnosed at that stage have a five-year survival rate of only about 29%.

So you can see why the need for ovarian cancer screening tests has attracted biotech companies in search of the next big thing. Unfortunately, no test has yet been shown to reduce the risk of dying from ovarian cancer in women who are thought to be at average risk for the disease.

For that reason, the U.S. Preventive Services Task Force has recommended since 2012 against the use of ovarian cancer screening tests for women who have no symptoms of the disease (the task force is working on an update of that recommendation).

The task force reviewed the research on two screening methods, the CA-125 blood test and transvaginal ultrasound. CA-125 (“CA” stands for “cancer antigen”) is a protein found in high levels in people with certain cancers, including ovarian cancer.

The problem is that not all women with ovarian cancer have high levels of CA-125 in their blood, while some women who don’t have cancer do have high CA-125 levels. Those so-called false positives could lead to unnecessary tests and even surgery. While the CA-125 test is used to monitor patients being treated for ovarian cancer, the task force found no evidence that it, with or without transvaginal ultrasound, saved lives when used for screening women with no symptoms.

The FDA’s safety communication cited a test marketed by Abcodia Inc.–a privately held company based in London that also has a Boston office–called the Risk of Ovarian Cancer Algorithm (ROCA) test. The ROCA test, launched in December in the United States and also available in the U.K.’s private healthcare market. It uses a woman’s CA-125 levels over time as well as whether she’s postmenopausal or has ovarian cancer risk factors to estimate her odds of being diagnosed with the disease.

The test is marketed for all postmenopausal women aged 50 to 85 and for high-risk women 35 to 85. It costs $295–not covered by Medicare or private insurance, Abcodia notes in small print–and is designed to be performed once a year or more frequently, depending on a woman’s risk. According to the Abcodia website, the ROCA test is available in the District of Columbia and every state except Alaska, Florida, Hawaii and New York.

A randomized U.K. trial involving more than 200,000 women, published online by the Lancet in December, found that women assigned to get the ROCA test had a lower risk of dying of ovarian cancer than other women in the study, but the difference was so small that it could have been due to chance. The study followed some of the women for nearly 14 years but concluded that it needs to track them longer to see if ROCA might further reduce the risk of dying from ovarian cancer as more years pass. Some of the authors of the study reported having financial ties to Abcodia as investors or consultants.

In an editorial published in May in the journal Gynecologic Oncology, three University of Toronto researchers concluded that the results of the large U.K. trial do not yet justify screening for ovarian cancer. “Before a screening program is widely implemented, the potential impact of screening on ovarian cancer mortality rates must be confirmed,” they wrote. “To date, no study has documented a reduction in mortality from ovarian cancer as a result of screening.”

I asked an Abcodia spokeswoman for a comment for this story, but she has not yet provided one.

I searched online for other tests being marketed for ovarian cancer screening but couldn’t find any. FDA spokeswoman Tara Goodin told me that the agency knows of two others, but they’re not on the market. The FDA hasn’t approved any, Goodin said.

“It is possible that other tests that are cleared or approved for other uses are being used to screen for ovarian cancer,” which would be an off-label use, she said. However, “the FDA is not aware of any valid scientific data to support the use of any test…as a screening tool for ovarian cancer.”

If that’s the case, how can Abcodia market the ROCA test? The FDA does regulate medical devices, including diagnostic tests, but historically it hasn’t paid attention to “laboratory-developed tests,” or LDTs, Goodin said. As the FDA website puts it, LDTs are diagnostic tests designed, manufactured and used in a single laboratory.

When the FDA first began regulating medical devices in the 1970s, “we chose not to enforce applicable regulatory requirements for LDTs because they were relatively simple tests generally confined to local labs and often used for rare conditions,” Dr. Peter Lurie, the agency’s associate commissioner for public health strategy and analysis, wrote in a blog post last November.

“But times have changed,” Lurie continued. “LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients.”

And yet, the FDA still has a policy of not regulating them, he noted. “That means they have rarely undergone FDA review to determine whether they are accurate, reliable and provide clinically meaningful results.”

Lurie’s post was pegged, as journalists like to say, to an FDA report that featured 20 case studies of questionable LDTs. While the ROCA test was not among them (I assume because it wasn’t yet on the U.S. market), the report does discuss two other ovarian cancer screening tests. One, OvaCheck, never made it to market. A second, OvaSure, one was pulled from the market in 2008 after the FDA issued a warning letter to its manufacturer.

“The FDA would quickly approve an ovarian cancer screening test that is shown to be safe and effective,” Goodin said. “At present, there is no evidence that such a test exists.”

To view this entire article on Forbes.com, please click here.