College of American Pathologists
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  What vendors are up to in POC and
  self-testing coag





cap today



May 2007
Feature Story

Anne Ford

As physicians oh-so-cautiously edge toward the possibility of patients performing their own coagulation testing, HemoSense vice president of marketing David Phillips is reminded of the early days of at-home testing in another field. “If you look back to the late 1970s, physicians were uncomfortable with patients doing their own glucose testing,” he says. “Now every physician expects their diabetic patients to do their own testing. The doctor knows the patient will take better care of themselves if they’re testing two or three times a day.”

So why are doctors seemingly slower to give their warfarin patients the go-ahead to self-test? Because “some physicians are apprehensive of prescribing warfarin,” Phillips says. “It’s a difficult drug to manage. You don’t know how the patient’s going to react to it.”

Still, he adds, “It’s beginning to get sorted out. There’s very few physicians I talk to now who don’t have one or two patients they feel comfortable could do it [coagulation testing] themselves, whereas five years ago, physicians would list many reasons not to prescribe it and virtually no reason to prescribe it. Once they have a patient begin to self-test, and the doctor receives good feedback from the patients, they begin to say, ‘Maybe I have a couple more patients that are able to do this.’ So this is beginning to be a growth area,” particularly as “baby boomers age and begin to develop the ailments of today’s 60- and 70-year-olds with atrial fibrillation or heart valve implants, DVT, other cardiovascular diseases.”

And, of course, manufacturers of self-monitoring coagulation analyzers—which this month’s survey addresses in addition to point-of-care coagulation analyzers—are taking heed.

At Roche, the big news in point-of-care coag is the CoaguChek XS Plus, which the company just submitted to the FDA for special 510(k) approval. Randy Pritchard, director of product marketing for near-patient testing, calls it “the high-end physician office meter,” meant for larger physician offices and clinics. The XS Plus will use the same strip technology as its predecessor, the CoaguChek XS, along with enhanced features such as a bar-code reader that automatically reads the strip and identifies the strip lot and resulting calibration, operator and quality lockouts, and connectivity features that allow users to upload patient lists and download results to and from the system. “It’s a real enhanced feature set for the professional office setting that’s seeing large numbers of patients and looking for efficiencies in their practice,” Pritchard says.

Meanwhile, the CoaguChek XS has news of its own. Launched in the United States for the professional market and the patient self-testing market, it represents the third generation of Roche’s CoaguChek family. “It’s the only system on the market that performs onboard quality controls and determines patient results in a single test chamber,” Pritchard says. “It saves time by allowing that meter to do all of those quality controls and still give you results in less than one minute.” It’s also, he says, the first point-of-care system that neutralizes therapeutic levels of heparin and low-molecular-weight heparin, “which really gives our customers a lot of flexibility in the patients that they manage.” Finally, “it used to be that our strips sat on top of the meter and you had a chance for contamination if too much blood was applied. It now protrudes out of the end of the meter, much like a diabetes meter. And that also gives you some more dosing flexibility, because our strip can be dosed now not only from the top but also from the side.”

Even though HemoSense is the latest market entrant, Phillips says, work on an updated INRatio PT/INR system is ongoing. “We’re constantly looking for ways to make improvements,” he says, such as improved capillary flow or increased manufacturing capabilities. With these and other advances, he adds, HemoSense can “continue to penetrate the growing point-of-care and patient self-te

sting markets.” Last year, International Technidyne Corp. introduced a new version of its ProTime PT/INR meter. “The new ProTime has an updated look and feel to this portable and easy-to-use diagnostic device,” Paul Savuto, director of marketing, says. “In response to feedback from customers, we have added the ability to enter patient and operator ID as well as enabling clinics, physicians’ offices, or hospitals to interface the ProTime to an electronic medical records system or information system. The connectivity feature reduces transcription error and speeds up record keeping.”

Also available in a new version: ITC’s Hemochron Signature Elite microcoagulation system, which “provides users with more flexibility and improved collection of data for maintaining QC statistics,” Savuto says. In addition to the new ProTime iteration, 2006 saw ITC acquiring Avox Systems and adding to its lineup the Avoximeter system for co-oximetry and oximetry testing. Savuto calls the Avoximeter 1000E “the leader in measuring cardiac output at the point of care” and the Avoximeter 4000 “highly cost-effective for measuring methemoglobin, carboxyhemoglobin, oxygen saturation, and total hemoglobin.” Later this year, pending FDA approval, the company aims to launch Hemonox, a low-molecular-weight heparin test that it has already introduced in Europe, in the United States.

CAP TODAY’s survey of point-of-care and self-monitoring coagulation systems includes products from the abovementioned manufacturers and from Abbott Point of Care, Helena Point of Care, Instrumentation Laboratory, and Medtronic Cardiac Surgery. Vendors supplied the information listed. Readers interested in a particular product should confirm that it has the stated features and capabilities.

Anne Ford is a writer in Chicago.


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