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HEADLINES:
Quidel New Product Launches
Prothrombin self-testing: where the lab comes in

Quidel New Product Launches

Quidel announced that, as part of an on-going integration of the urinalysis product line acquired from Dade Behring, it has received CLIA-waived classification of the QuickVueT UrinChek urinalysis product from the FDA, under the Clinical Laboratory Improvement Amendment of 1988 (CLIA). The CLIA-waived status allows a broad base of physicians to perform the test at the point-of-care setting, further complementing Quidel's existing point-of-care business.



The QuickVue UrinChek urinalysis product is an important tool available to the physician for overall assessment of patient health. The test is simple to use and provides results in an easy-to-read dipstick format. The Company will launch the QuickVue product line in the United States in the third quarter, rather than the second quarter as originally planned.

Q.A. Point-of-Care Services division of Q.A. Services, Inc. Establishes Internet Presence
See the press release for more details.

Recent Media Coverage of Q.A. Point-of-Care Services division of Q.A. Services,Inc.


Q.A. Services, Inc., Home Test Medical Division, Repertoire Magazine, June 1999

You can take Mike Visnich out of the distributor, but you can’t take the distributor out of Mike Visnich.

Visnich, a 22-year veteran of medical products distribution, is taking advantage of four huge trends - miniaturization of technology, consumer activism, disease management and the Internet - to build a distribution company that bears little resemblance to distributors of the past.

Visnich is building his company - Quality Assured Services, Orlando, FL - to be the most complete home testing resource on the Internet. Already, the suburban Orlando company is the only anticoagulation specialty distributor in the United States, distributing International Technidyne Corp.’s ProTime® Microcoagulation System throughout the country. And he’s always looking for the next new product.

For Visnich, looking ahead is nothing new. When he was at General Medical, he was an alternate site crusader and created the company’s VIP program, the first national affinity program for physicians. His last title there was vice president of alternate site marketing.

Today, the patient home testing market is as full of potential as the alternate site was 10 or 20 years ago, he says. Technology has made it possible for patients to buy devices they can use easily in their own homes. In addition, the continuing push to lower health care expenses and improve disease management - perhaps best accomplished by prevention of disease - leads straight to home testing.

ProTime® is a perfect example. Patients on blood-thinners, such as Coumadin (warfarin), need to be tested for prothrombin time. Traditionally, that has meant monthly (or more frequent) trips to an anticoagulation clinic or doctor’s office and a venous draw. But products such as ProTime® allow them to do it in the home, with a doctor’s prescription.

New territory

To get the product to the point of use, Visnich acts as a traditional distributor: Quality Assured Services receives products, stores the cuvettes in a refrigerator, then ships them out to patients via air freight.

But beyond that, the company is treading territory seldom seen by traditional distributors. For example, Office Manager Nancy Clubb spends most of her day compiling letters of medical necessity and talking to insurance companies to try to get reimbursement for the device and disposables.

It’s complicated work, she says, because each state has different regulations, each employer offers different plans, and in many cases, more than one insurance company is involved in the claims. In the end, QA is batting about .700 with insurance—that is to say, 70% of the private insurance claims filed actually are reimbursed. (Medicare does not cover the device.)

"Not everyone is a candidate for home anticoagulation testing," says Visnich. Patients who frequently miss their checkups, or who have had prior health problems, or who simply are too busy for regular checkups are best suited for the procedure. But that’s a case that the company must make to insurers.

Quality Assured Services is developing a network of nurse trainers to help new patients learn how to use the ProTime® device. Moreover, the company keeps detailed information on its patients and products, tracking lot numbers, fielding complaints on the phone, and handling and reporting problems quickly. "We do a lot more record-keeping and tracking than most distributors," says Visnich. "We’re on call 24 hours a day."

In addition to supplying tests to patients’ homes, the company also sells CLIA-waived devices and tests to clinics and doctors. (The name of its physician sales division is Q.A. Point-of-Care Services, and it can be accessed on the Internet at qapoint-of-care.com.) The company also distributes the LXN Duet Glucose Management System to consumers and physicians.

Says Visnich, the physician market creates a referral base of patients who are candidates for self-testing. In addition, the company pays finders feeds to distributors (reps or companies) who refer patients through their doctor customers, and pledges not to market for direct physician office sales to the referring distributor’s physician customers.

Dr. Sheila Dunn, a shareholder in Quality Assured Services, will host the physician website with advice on CLIA and OSHA matters, and she will produce an e-mail newsletter on the subject.

Internet

Quality Assured Services is building an infrastructure of product support that can put new products - particularly home testing ones - on the map, says Visnich. "We want to help new manufacturers gain entry into the patient self-testing and physician markets by offering them help with regulations,reimbursement, marketing and distribution," he adds.

The Internet figures to play a key role in its future. "Our strategy is to build an audience, so that when a new product comes out, we will get traffic to our site, which will be known for home testing," he says. (The company created a Home Test Medical division for consumer sales on the Internet. It can be accessed at hometestmed.com.) Visnich’s goal is to become nothing less than the most complete resource for home testing and CLIA-waived testing on the Internet. Always the distributor, he intends to distribute home testing devices and supplies that are featured on other websites as well as his own.

The explosion of health-care-related sites on the Web offers a golden opportunity for distributors such as Home Test Medical, he says. "Manufacturers [of home testing equipment] don’t want to deal with every company that has a website. After all, these companies aren’t distributors, they’re information brokers." So, consumer requests for home testing devices would be funneled directly to QA, not to the webmaster of the site.

"We think the home testing category can be plugged into many Internet sites," Visnich says. Given his nature as a distributor, he’s bound to find them.

(Editor’s Note: Mike Visnich and Dr. Sheila Dunn are co-authors of the chapter on home testing in the soon-to-be published book Point-of-Care:

Principles, Management and Practice, edited by Gerald J. Kost, M.D., Ph.D., University of California at Davis, McGraw-Hill. They also are working on a book that will list home test diagnostic products and information. They will publish excerpts of the book as well as product reviews on their Internet sites.)