Talking with S. Wayne Kay: Quidel Corp.'s CEO shares his views - Expert Opinion - Interview

Medical Laboratory Observer, Feb, 2003

Interview by Celia Stevens

Celia Stevens: As the leader of a fast-growing company, what in your view are the key trends that will most affect the future of the clinical diagnostics industry?

S. Wayne Kay: There are several trends we watch closely as we strategically plan for the future. First, it is clear that the clinical diagnostics industry is moving from centralized laboratory diagnostics to more at-patient care or near-patient care venues. This makes our product focus--rapid point-of-care (POC) testing at the physician's office--a very dynamic place to be. Increasingly, patients are becoming more knowledgeable and concerned about their healthcare and are becoming self-reliant in dealing with common health problems. Physicians are utilizing rapid POC tests as an aid in the diagnosis of diseases and conditions, while the patient is in the office as a "test-and-treat" model.

Another key trend is the aging population and its own desire to manage chronic illnesses. This aging group wants to know and more fully understand its health challenges. This profile, coupled with the medical information so readily available electronically, forces marketers to pay special attention to education strategies. We aim to develop education programs to increase awareness of our diagnostic tests to the three critical decision makers regarding family healthcare: providers, payers and patients.

Stevens: What impact will genomics and proteomics have on your future product offerings?

Kay: Quidel expects rapidly evolving genomic and proteomic discoveries to significantly expand the spectrum of diagnostic and monitoring opportunities that address important chronic and acute disease states.

Stevens: When Quidel began operations in 1979, its first product launches were in the area of reproductive and women's health, such as dipstick-based pregnancy tests. Quidel's product introductions in 2002 included a urine chemistry analyzer and a point-of-care ultrasonometer to aid in the diagnosis of osteoporosis. Judging from that, Quidel appears to be moving away from its original focus of reproductive and women's health. Why is that, and if so, in which direction is Quidel now heading?

Kay: I don't think we are moving away from women's health at all--we have just expanded our portfolio to include offerings that can serve women and those she cares about--older parents and children. Did you know that women make the majority of the healthcare decisions for these groups?

The Quidel Mission statement remains, "Helping women and their families live healthy lives." As we strategically expanded our portfolio, we wanted to further support this mission.

Urinalysis is the number one test performed in physicians' offices, including the OB/GYN, and offered Quidel a product that served all patient populations and a variety of clinical settings. The ultrasonometer, called QUS-2, is an instrument that measures bone density in the heel, and is a natural line extension to serve the osteoporosis area. In fact, placements of this lightweight and portable instrument are most prevalent in the OB/GYN clinics and wellness centers. Finally, our QuickVue Influenza test has achieved 50.5 percent market share, based on unit sales, number one m the first three seasons, and provides fast and easy-to-read results for patients visiting the family practice or pediatric offices.

The physician can look to Quidel as a leader in providing a complete wellness and disease management program that serves the entire family.

Stevens: Do you believe demand will heighten for point-of-care testing products in the next five years? Why?

Kay: Yes, I do. The movement towards decentralization of the laboratory and the need for more accessible diagnostic testing where the physician can test and treat will contribute to this demand curve. This speed of service--fast turnaround times--combined with a medically important need to diagnose and treat as quickly as possible, makes our mission exciting. Another important patient example is POC testing, which enables motivated patients to manage their own health status, to take back control many thought was lost upon diagnosis of a chronic disease. Diabetes management is a good example of this trend. Diagnostic tests provide information, so in a way Quidel is in the information business. As such, we have a responsibility to respond quickly and accurately. That's why our investment in new platforms like our LTF technology is so important.

Stevens: 'What is LTF?

Kay: LTF or Layered Thin Film is a proprietary platform only available from Quidel. It is as small and thin as a credit card, yet extremely precise with fast results--some within two minutes. LTF is not only very sensitive, it is also simple to use and offers the healthcare professional a tool to rapidly test patients without the complicated steps found even in some current lateral flow technology. Our QuickVue Advance tests for infectious vaginitis, introduced in late 2002, are the first available on LTF.

Stevens: How has the threat of bioterrorism affected Quidel's strategic planning in infectious disease testing?