News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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LabCorp Stops Selling OvaSure Ovarian Cancer Test after FDA Letter

Facing pressure by the Food and Drug Administration over its OvaSure test for ovarian cancer, Laboratory Corporation of America announced last Friday in a Securities and Exchange Commission filing that it had stopped sales of the test. The dispute between the FDA  and the nation’s second largest laboratory company will be closely watched for insights into how the FDA regulates “home brew” assays.

In the October 20, 2008 issue of The Dark Report, an intelligence briefing provides an assessment on the issues of concern to the FDA about the OvaSure test for detection of ovarian cancer. It was these concerns which led the federal agency to send an initial letter and then a warning letter to LabCorp in recent months.

The current troubles swirling around the OvaSure assay represent two unfolding trends in laboratory medicine-and healthcare in general. One is the trend for new healthcare technology to have a demonstrated clinical benefit, along with a reasonable cost to achieve the improvement in clinical outcomes. Two is the repeated statements by the FDA that it sees the need for tighter oversight of diagnostic assays which incorporate molecular technologies.

The first trend came into play shortly after LabCorp, last June, began selling the OvaSure test as one method to detect cervical cancer. A number of physicians quickly criticized this decision. They argued that data from the clinical trials used to evaluate the OvaSure technology was not comprehensive enough to appropriately support how LabCorp recommended that physicians use the OvaSure test to detect cervical cancer. It didn’t take long before certain women’s health advocates also chimed in with criticism of LabCorp’s marketing of the OvaSure test. These criticisms were similarly rooted in a belief that the data from the clinical studies did not fully support the marketing claims for the test.

As to the second trend, the FDA seems to have noticed these public criticisms. It sent a letter to LabCorp late in the summer describing its concerns. Apparently, the FDA was not satisfied by whatever response was provided by LabCorp, because the agency then sent a warning letter to LabCorp earlier this month. In this correspondence, the FDA again questioned the adequacy of the clinical data used to support the manner in how the OvaSure test is marketed. The federal agency also, in its letters, noted that LabCorp was purchasing components of the test from Yale University and was thus not compliant with aspects of the home brew requirements.

By its actions, LabCorp has obviously decided that the best response to the FDA’s stop letter is to cease sale of the OvaSure test. This story has several chapters yet to come, depending on whether LabCorp wants to pursue its case with vigor and whether the FDA takes additional steps to rein in other home brew assays that many laboratories currently offer in today’s clinical marketplace.

For medical laboratories, there are two useful lessons to draw from the flow of events to date. First, a new laboratory test coming to market will have a much easier time gaining acceptance by physicians and payers if that test has strong clinical data to support its clinical efficacy, as well as its cost effectiveness.

Second, the FDA has once again served notice that it is concerned about home brew assays. This is not auspicious for the nation’s molecular testing laboratories, since any additional regulations will make it tougher for these laboratories to offer “home brew” assays to clinicians. It would also make it tougher for labs to gain additional knowledge about how home brew assays perform in clinical use.

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Shrinking Computer Chips Expand Market for Point-of-Care Handheld Devices

Siemens AG has introduced a PDA-sized portable ultrasound machine dubbed the P10 that allows emergency room doctors to assess patients quickly and easily. Devices like the P10 are possible largely because analog chip makers are racing to develop electronics that allow portability. Like cell phones before them, these portable ultrasound machines will become increasingly smaller, faster, and cheaper over time. They will also consume far less power than their full-sized counterparts.

Technology advances like these will also trigger new, smaller analyzers for in vitro diagnostics. The explosive growth in this market is demonstrated by a simple fact: semiconductor sales associated with medical equipment totaled $3.02 billion in 2007, up 65% from 5 years ago! Sales of portable systems-those weighing less than 11 lbs-climbed 42% to $565 million last year and are forecasted to reach $1.2 billion in 5 years, according to Klein Biomedical Consultants, Inc., General Electric Co’s GE Healthcare, SonoSite Inc., and Zonare Medical Systems, Inc. together accounted for 85% of the market in 2007.

These portable devices are expected to make ultrasound, which has traditionally been limited to radiologists, cardiologists, obstetricians, and gynecologists, available to new classes of specialists, including anesthesiologists and emergency care physicians. The expanded use of ultrasound could help cut healthcare costs through earlier and more accurate diagnoses.

Technology incorporated in the P10 and other portable ultrasound devices does need improvement. For example, the P10 currently does no show color, so doctors won’t see some problems. Its battery life is limited to four hours of normal use. Refinements to improve image quality and reduce power usage in the pipeline and will soon reach clinical use.

The refinement of computing chips for use in portable ultrasound devices is of note to laboratory staff because this technology has easy applications in creating more and better portable laboratory testing devices. That will expand the types of near patient and point-of-care (POC) testing systems available for diagnostic purposes. It will also enable a new generation of patient self test systems to find ready acceptance by patients. In fact, the development of blood glucose monitoring systems for diabetic patients provides one good example of how manufacturers are regularly adding new features and capabilities to these consumer self-test products.

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