Interview with Hank Nordhoff, Chairman, President, and CEO

 Hank Nordhoff

Gen-Probe is a global leader in the development, manufacture, and marketing of rapid, accurate, and cost-effective nucleic acid testing products used to diagnose human diseases and to screen donated human blood. Clinical Lab Products recently spoke with Hank Nordhoff, Gen-Probe’s chairman, president, and CEO.

CLP: Please tell us about Gen-Probe’s history.

HANK NORDHOFF: Gen-Probe has a more than 20-year history of innovation in molecular diagnostics. We put the first FDA-approved DNA probe test on the market in 1985. We also developed the first amplified nucleic acid test, or NAT, for blood screening, which was approved for marketing in 2002. We were part of Chugai Pharmaceuticals until September 2002, when Chugai merged with one of our major competitors and spun us off to avoid US antitrust conflicts. So we are a young, independent public company, but a very experienced one.

CLP: What are the key technologies you have developed over those two decades?

 HN: Gen-Probe is built around four synergistic technologies. First, many of our assays target ribosomal RNA, which can be as much as 10,000 times more abundant in cells than DNA. Targeting ribosomal RNA dramatically increases the sensitivity of these tests. Second, our target capture technology uses magnetic beads to concentrate these highly specific nucleic acid targets from patient samples. This eliminates the need for labor-intensive purification steps and increases test sensitivity, which helps prevent false-negative results. Third, we use transcription-mediated amplification, or TMA, to produce more than 10 billion copies of a target in less than an hour. TMA is more robust, faster, and easier to use than PCR, and reduces the potential for laboratory contamination. Fourth, our DNA probes are labeled with chemicals called acridinium esters, a chemiluminescent detection technology that is simpler and more sensitive than those used in most competing assays. Together, we believe these proprietary technologies represent the most exciting platform in the diagnostics industry.

Based on these technologies, for example, our amplified APTIMA Combo 2® assay can simultaneously detect chlamydial infections and gonorrhea in urine with the same sensitivity as from cervical and urethral swabs. Men obviously prefer a urine test to a urethral swab. And for women, ours is the only FDA-approved test to detect sexually transmitted diseases from a vaginal swab, which can be self-collected in a doctor’s office or clinic. The self-collection indication should help us increase testing in public health and university settings.

CLP: What are the key products Gen-Probe has developed with its technologies?

HN: Clinical diagnostics has been our historical base, and we market NATs for sexually transmitted diseases, tuberculosis, strep throat, pneumonia, and fungal infections. The APTIMA Combo 2 assay, which was approved for marketing in 2001, is gaining share rapidly among amplified STD tests. We also market PACE 2C®, an easy-to-use, nonamplified assay for the same two STDs. PACE continues to be the only product in the nonamplified portion of the market, given the added sensitivity that can be achieved only through our ribosomal RNA technology.

In blood screening, our Procleix® HIV-1/HCV assay, marketed by our blood-screening partner, Chiron, is used to safeguard more than 80% of the US blood supply. Although the Procleix assay already has a dominant position in the United States, its use is growing rapidly worldwide as more countries adopt highly sensitive NAT testing. In addition, US customers are using our new test for West Nile virus to protect the blood supply under an investigational protocol.

CLP: And how does your new TIGRIS® instrument [shown at right] fit into the product portfolio?

HN: The TIGRIS instrument, which was approved by the FDA in December to run our APTIMA Combo 2 assay, is the first to offer lab technicians what we call “absolute automation,” which is true, walk-away freedom in all phases of the test procedure. There’s absolutely no hands-on processing needed to prepare samples, to amplify and detect the nucleic acid targets, or to analyze the results. For example, there is no need for manual pipetting, since the robotic system samples directly from primary sample tubes through a nifty penetrable cap we developed. Similarly, there is no need to concentrate and isolate organisms using a centrifuge or filtration. With our target capture technology, all purification steps are done in the assay tube by the TIGRIS instrument, eliminating the need for expensive, often manual sample preparation steps required in many of our competitors’ systems.

The TIGRIS instrument is fast and very easy to use, so it will play an important role in helping our customers do more with less, despite the persistent labor shortages they face. One trained technician can operate two or three TIGRIS instruments simultaneously, so a lab tech using the system could be many times more productive than someone using semiautomated instrumentation, and could even have time for other high-value activities. So the TIGRIS platform offers an integrated package for customers: reduced labor costs, fewer ergonomic injuries, less lab space, fewer human errors, and of course, much higher productivity. As a result, high-volume screening tests for infectious diseases, the blood supply, and cancer are ideal applications for the TIGRIS platform.

CLP: What new tests is Gen-Probe working on?

HN: In blood screening, we plan to file a biologics license application this year for our Procleix Ultrio™ assay, which adds a test for hepatitis B to our approved assay for HIV-1 and HCV. And we expect to file for regulatory approval of our West Nile virus assay in the first quarter of 2005. Through the end of last year, the test had detected nearly 900 West Nile–infected units out of about 6 million blood donations. Since one unit of blood can be transfused into as many as three people, our test may have prevented thousands of transfusion recipients from receiving contaminated blood.

In clinical diagnostics, we’ve acquired from Canadian-based DiagnoCure the exclusive worldwide diagnostic rights to a gene called PCA3. Early clinical data indicate PCA3 is a new, highly specific genetic marker that is overexpressed in prostate cancer cells. We’re very excited about developing a urine test for PCA3, given the well-known limitations of prostate specific antigen (PSA) testing. Because PSA is specific for prostate tissue, not prostate cancer, only about 25% of patients found to be positive (>4.0 ng/mL) by PSA screening are confirmed by a first biopsy to have cancer. This translates into a lot of uncomfortable, expensive, and ultimately unnecessary biopsies. In contrast, clinical studies of a first-generation PCA3 test in more than 400 men with elevated PSA levels showed that the test had a positive predictive value of 75%. Reducing the number of “false-positive” results compared to PSA testing could drastically reduce the number of unnecessary biopsies, eliminating strain on patients and on health care payors.

CLP: What is the most challenging aspect of your job at Gen-Probe?

HN: We have a wealth of growth opportunities, especially in R&D, and the hardest part of my job is deciding which ones to develop by investing people and funds. We’re still a small company relative to many of our competitors, and we don’t have unlimited resources, so we have to choose wisely. We use a very sophisticated portfolio management process to help us think through which projects provide the highest returns for customers and shareholders. And we try to balance Wall Street’s appetite for short-term earnings with our desire to fuel long-term, sustainable growth.

CLP: Along those lines, where do you see your company in 5 years? Which growth opportunities do you plan to pursue?

HN: We will continue to be a leader in STD testing, and we will strengthen our position even further based on the automation offered by the TIGRIS instrument. We intend to leverage our TIGRIS platform to become a leader in cancer diagnostics, starting with our prostate cancer test. We also are moving toward a test for human papillomavirus, or HPV. We are not currently a player in HPV, but intend to announce our strategy for entering that market this year. Working with partners, we will expand our core NAT technologies into large markets, such as industrial testing. And we will continue to evolve into a much more international company, both in blood screening and clinical diagnostics.