An Interview with Douglas Bryant, CEO

Douglas Bryant, CEO

Quidel Corp, San Diego, launched its first product—a dipstick-based pregnancy test—in 1984, and since then it has made continuous strides in infectious disease, women’s health, and oncology testing through product-line acquisitions and cutting-edge technological developments. Best known for manufacturing the QuickVue line of influenza tests, the company is also branching out into molecular diagnostics. As labs across the country begin diving into a challenging new flu season, Quidel’s new CEO, Douglas Bryant, spoke with CLP about advances in respiratory virus testing, when labs should start ordering tests, and his long-term strategies for taking the company to the next level.

CLP: Tell us a little about your background. What brought you to Quidel?

Bryant: I became president and CEO on March 1 of this year. I was attracted to the quality of Quidel’s brand and the company’s presence in physician’s office laboratories and hospitals. I also understood that I would have a strong mandate to take the organization to the next level and look at new opportunities, including in the molecular diagnostic space.

Prior to joining Quidel I was executive vice president and CEO at Luminex, based in Austin, Tex, and previously I held a number of worldwide commercial operations positions with Abbott Laboratories. Overall, I spent just over 24 years with Abbott.

CLP: What directions do you plan to take the company in to fill existing needs in the marketplace?

Bryant: The first thing is we intend to expand the portfolio of products we have, and we’ve committed to introducing two to three new products per year using our existing lateral flow technology.

In addition, we’ve used distributors exclusively for both the physician’s office and the hospital laboratory segment—and have done so successfully—but we would like to take steps to understand our customer base a little better. We’re looking at adjacent markets that our current distributors have not emphasized. In other words, additional locations where our tests can be distributed.

CLP: What are some of the latest advances in respiratory virus testing?

Bryant: Internally, we’re working on two ideas: One is an interim step to improve the sensitivity of our assays for flu and strep. Longer term, we intend to develop a molecular-based application. In terms of the number of the latest advances in respiratory virus testing, a number of companies already have PCR-based assays for respiratory viruses. And while the assays do take more skill and time to perform, they’ve been very helpful to government agencies and public health and surveillance. We see a need for something significantly less costly, easier to perform, and faster—that’s what we’re aimed at.

CLP: Flu season is fast approaching. What is Quidel’s strategy for effectively dealing with it this year?

Bryant: Since late April, we’ve been running two 10-hour shifts per day, 7 days a week. We’re continuing to manufacture at this level as there has continued to be a strong demand for Quidel’s rapid influenza test.

Furthermore, the company instituted a program about 2 years ago to develop correlation test panels that can help acute care labs correlate, perhaps substitute, with Quidel’s rapid flu test. This may help labs avoid some of the shortages they experienced this past May when flu cases spiked after the end of the usual season.

The most important thing we can do is make sure that we have the product available for the physicians’ offices and labs that need it.

CLP: Are you anticipating a surge in demand?

Bryant: Well, I would say right now, we’re seeing increased demand in the Southeast of the US. It’s very clear now that school is back in session that we’re in the very beginning of the flu season in some parts of the US.

CLP: Do you expect this flu season to be any different or more challenging for labs than past ones?

Bryant: Well, given the data we’ve seen so far, we believe millions more people are likely to be infected with the influenza virus this coming season than in the past. Although we’ve heard quite often that symptoms are on average expected to be milder than previous flu seasons, we expect to see greatly increased numbers of individuals infected. It potentially could be a tremendous strain on labs.

We’ve instituted measures such as just-in-time manufacturing for this eventuality. We’re actually not asking labs to order product until they need it. So we are manufacturing to the pouched stage and then shipping when the orders come in.

CLP: Do you usually sell flu testing products mainly during the traditional flu season?

Bryant: That’s right. Typically, the flu season runs between October and the end of March. This year we had a very mild season the first quarter of 2009, then at the very end of April, beginning with the outbreak in Mexico and when this swine flu became an epidemic, we began manufacturing product at a time when we don’t usually manufacture it.

CLP: Was the increased demand challenging for distributors?

Bryant: I think that in May we saw here in the US that there were a number of instances where supply was quite tight. And we didn’t actually have a situation where we stocked out, but I can imagine there were shortages depending on location.

CLP: Let’s talk about your recent flu season Webinar. What prompted you to host it?

Bryant: We host Webinars from time to time as part of the company’s initiative to educate and inform the health care community regarding methodologies procedures. The recent Webinar, hosted by John Tamerius, PhD, our senior vice president of clinical regulatory affairs, was prompted by our desire to reinforce the appropriate use of the company’s QuickVue Influenza A+B test, and to encourage clinicians and other practitioners to follow instructions provided in the diagnostic package insert.

We view this important given recent external studies for which researchers generated results for their tests using influenza specimens that were not tested immediately, but instead were shipped and stored in a manner that might not result in optimal performance. So the Webinar allowed the company to detail methods for achieving the best results possible for using the test. Our studies have shown that the company’s influenza test, when used according to established procedures, actually has demonstrated a 94% clinical sensitivity and a 90% specificity compared with culture in detecting seasonal influenza type A with a nasal swab.

CLP: Can readers access an archived version of the Webinar online?

Bryant: A multimedia version of Quidel’s recent Webinar is available on the company’s Web site through the end of 2009, at www.quidel.com/webinars.

CLP: Specifically, what should labs look for when determining if a particular diagnostic test is right for them?

Bryant: I think it’s common for labs to look at performance first—the clinical sensitivity and specificity of the assay. I think it’s clear that labs today also look at costs and at time to results.

CLP: Have there been recent developments in the Quidel oncology testing products?

Bryant: Yes. We previously announced that we are set to launch by the end of 2009 a second-generation fecal immunochemistry test. We can now get a result now in 5 to 10 minutes in a one-step procedure with room-temperature storage of the product and 24-month dating. There’s a built-in internal control and now there are no dietary or medical restrictions.

CLP: Tell us about your strategy for moving into the molecular space. What tests are you working to develop, and what strategies are you taking?

Bryant: We started about 3 years ago on an internal development program in molecular diagnostics, and we’re now at the stage where we have one prototype assay.

In addition, we’re looking to acquire various constituents important to a molecular diagnostic platform from extraction to amplification and detection. In the longer term, this may result in us acquiring companies with assets that are of interest to us. In some cases we may seek to acquire products when they are of interest to our portfolio. We’re clearly interested in things that are consistent with where we do well and where we have strong brands. Clearly, respiratory and other infectious diseases would be of interest to us, particularly where good molecular solutions don’t currently exist.

Stephen Noonoo is associate editor of CLP.