FDA to seller of ovarian-cancer test: You need permission

The marketer of a test for ovarian cancer doesn't actually have approval to sell the product, the Food and Drug Administration told the company late last month.

In a letter dated Sept. 29, the company, Laboratory Corp. of America Holdings, was told it was violating a law requiring marketing clearance for devices used in the diagnosis of diseases or other conditions before they're offered for sale.

The director of the FDA's Center for Devices and Radiological Health went on to explain the whys of the alleged violation in more detail. The letter then said in part:

"Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice."

Ovarian cancer is difficult to diagnose in its early stages -- and difficult to cure in its later stages. A recent Associated Press story explains the context for this latest action: Hope, confusion surround quest for early ovarian cancer tests.

-- Tami Dennis

Comments

[Jay Bee]

Good for LabCorp!!

I am proud of LabCorp for circumventing the FDA.

I hope more companies do the same thing. Companies are absolutely fed up with the FDA's useless efforts.

Anyone with an average or better IQ who has ever had the utter displeasure of working with the FDA on clinical submissions would agree that the FDA is blatantly and consistently preventing necessary health innovations from getting to the US market!

Most companies sell their products to other countries.

Thanks FDA. Thanks for continuing to be self perpetuating and thanks for wasting hard earned tax dollars. Time and time again, the FDA severely messes up, and never has any accountability for their consequences!

The FDA needs to employ intelligent people, and let the people of the US enjoy health innovations.

-Peace

[Q Public]

I agree that the FDA is a mess. And why should someone even need FDA approval for a diagnostic kit -- unless there's some reason to think it's dangerous. I'm sure it's not as dangerous as a cell phone, which the FDA approved with no testing... even though decades of research suggest microwave transmissions alter the brain's EEG and are a probable carcinogen (see Frey's book).

[Guy Fauks]

Get the FDA out of regulating tests.

Lets focus on safe food, and treatments and medicines that don't kill people, and not waste time on tests.

The worst that could happen is the test is worthless and gives garbage results. Nobody dies from that, even if they have cancer and it does not detect it. More than likely with the limited and artificially restrained options we have, most people will develop symptoms (illness) before long after, and they would not have a competing reliable test to take anyway.

Time to let the market go on this and just make sure there are no secrets, but anyone can choose to take a non-fda approved test any time they want without consequence and the FDA can not restrict this option.

[Samba]

The F.D.A. is not into saving people they are the opposite They let contaminated foods come into our country without proper testing They promote drugs that will have side effects without proper testing cause money talks and drug companies have plenty to spend.
Anything that will help you obviously does not qualify for their list.

[D Angel]

A test like this does indeed have potential adverse consequences for the person being tested. A seemingly simple blood test has great potential for harm. This is largely due to false positives. There is rarely a test in medicine that has 100% sensitivity and specificity (means a positive test guarantees you have said disease). A good example of this is the prostate antigen test. That test (which is approved) is fraught with false positives causing many men to undergo painful biopsies to prove they don't have cancer. The FDA is not perfect, but new tests do need due diligence and thorough evaluation such that patients can be educated / warned of the true false positive and false negative rates before they have the test. This information usually must be confirmed by independent researchers that are unbiased (have no financial ties to company who sells the test). If a woman is found to have an abnormal ovarian cancer test, she may develop anxiety problems and also may undergo unnecessary surgery or biopsy. This happens with the CA-125 test sometimes. There is definite morbidity from false positives and even chance of death if complications arise from surgery. That is why tests like this are regulated. Also it is naive to suggest FDA promotes drugs without testing. All drugs in US get tested to some degree before approval. All drugs have potential side effects. Blood tests have potential side effects as well.

[Dr. Dave]

The issue of course is that test results DO have consequences. A false positive test result may lead to chemotherapy, very expensive and dangerous when not absolutely necessary. A test sold by someone can be bought and used by any lab. FDA regulates it to ensure consistent results no matter who runs the test.

There are, however, "home brew" tests. The lab must convince the medical community - and 3rd party payers - that the test is worth ordering and paying for. FDA does not regulate these tests.

So: is this a home-brew or not? Is FDA doing this to reign in a very large testing lab for business reasons? Hmmm.....

[BenR]

As a clinical (esoteric) Lab Director and as one who is following the OvaSure saga, I want to express my sympathy with all who wrote "support" for LabCorp or dismay at the FDA. FDA needs an urgent overhaul. It is an agency that under the umbrella of consumer protection highly impedes, obliterates and unnecessarily interferes with innovations, some of which have a potential of being life saving products. We can have regulation without the hassle. The diagnostic industry in general deals with non invasive products. A result obtained using a diagnostic kit/device may lead to an intervention (invasive or drug-related), and some of such interventions have low percentage of life-threatening side effects. Hence there is a need for some regulation. However, the level of regulation imposed by CLIA is definitely sufficient if overseen correctly, since most if not all elements of the FDA requirements are covered by the CLIA oversight. There is no need to make the the diagnostic industry suffer the heavy burden of additional regulatory hassle.
Here are some, off the top... ideas on what I think should guide regulation on diagnostic products:
1) If a new test product shows a good predictive value, e.g. anything above 90% (note - many test in the market have 60-80%, or even less); or if such a pruduct was included in a scientific peer-reviewed publication showing it to be better than existing products IT SHOULD BE GIVEN MUCH MORE LENIENT TREATMENT BY REGULATORS. This will help expedite its introduction and save lives.
2) FDA has in the drug approval system a stage IV concept, which for some relevant comparisons is featured by the premise that FDA has gathered enough data to approve, but "feels" it would be in the interst of the medical society and the consumers if the manufacturer continued to gather information extending previous studies and increasing the n for better confidence in the statitical analyses. During this period, the manufacturer/service provider can sell the product for profit. I would love to see all diagnostic products that emanate from an already scrutinized (peer-reviewed) publication given this status. All products fulfilling the previous argument should definitely be given this status.
3) Whoever ends up regulating this industry should adopt the approach of running some statistics and asking the question regarding the economy of life saved vs life lost before throwing the argument of life threatening features in any statement: How many lives may be saved by a potentially life saving test, vs how many lives will be lost in the rare event that a positive results leads to a treatment, which also happens to result in an adverse event, and the adverse event is fatal. I feel certain that OvaSure would pass with flying collars.