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San Diego: Perfecting Paradise, Copyright 1999 by Heritage Media Corporation


The health care environment is changing rapidly - escalating costs, the emergence of managed care, and declining government funding have resulted in a price-sensitive market demanding simpler, more automated diagnostic methods. New infectious diseases and microorganisms that are resistant to antibiotics also pose a challenge. Diagnostics will play an even more important role as earlier detection and faster intervention will improve patient health care and help reduce costs. Screening of high risk population segments for specific diseases as well as screening the blood supply using the latest technology to ensure there is an acceptably low risk of transmitting diseases are also areas of increasing importance to our society.

Since its founding in 1983, San Diego-based Gen-Probe has never forgotten that its ultimate customer is the patient. Gen-Probe, a wholly-owned subsidiary of Chugai Pharmaceutical Co., Ltd., a major Japanese pharmaceutical company, has become one of San Diego's premier biotech success stories. The company is internationally recognized as a leader in the development, manufacture and commercialization of genetic probe tests for diagnosing human diseases, including tuberculosis, strep throat, pneumonia, fungal infections and sexually transmitted diseases such as chlamydial infections and gonorrhea. It is currently developing tests that will make our blood supply the safest it has ever been.

Since its first FDA-cleared product in 1985 (a culture confirmation test for Legionnaire's disease), Gen-Probe has developed and marketed over 40 products. The company sells several product lines including the PACE(r) 2 System, the ACCUPROBE(r) System, the ACCUPACE(r) System, and the GEN-PROBE AMPLIFIED Direct Test System.

Three proprietary technologies form the foundation for Gen-Probe's revolutionary genetic probe tests: 1) Targeting of ribosomal RNA (rRNA), an abundant species of nucleic acid found in all living cells; 2) Hybridization Protection Assay (HPA), an extremely sensitive and convenient means of detecting nucleic acid hybridization; and 3) Transcription-Mediated Amplification (TMA), a process for increasing the number of target nucleic acid sequences to allow detection of even a single nucleic acid molecule.

Gen-Probe has successfully combined these and other technologies, enabling clinical laboratories to obtain test results in hours instead of days or weeks with accuracies that have made the Gen-Probe assays the reference standard for many applications.

Over the years, Gen-Probe has achieved a number of industry 'firsts:'

  • first company to receive FDA clearance to market a clinical diagnostic test using genetic probe technology;
  • first to market a test to detect both chlamydial and gonorrheal infections using one test method and one patient specimen;
  • first FDA approved direct amplified test for the detection of Mycobacterium tuberculosis, which cut the time to diagnose tuberculosis to a few hours instead of the weeks to months needed by the culture method.

In 1999 the company anticipates placing the first fully automated, high-throughput DNA probe instrument system, TIGRIS(tm). Designed for use with Gen-Probe's amplified tests, the TIGRIS system will integrate the sample processing, amplification and detection steps into one instrument and will be able to process 1,000 tests per 12-hour shift, making it especially effective for high-volume testing.

Also key to Gen-Probe's success has been the formation of strategic alliances, collaborative partnerships and global distribution agreements. Gen-Probe was selected by the National Institutes of Health to help meet the government's commitment to ensure that our nation's blood supply is as safe from infection as the latest technology will allow. In 1996, the National Heart, Lung and Blood Institute (NHLBI) awarded Gen-Probe a $7.7 million contract to develop a screening system for HIV and hepatitis C for the nation's blood supply. This test is expected to be placed in blood banks across the country by the end of 1999.

In 1997, Gen-Probe signed a cooperation agreement in the field of molecular diagnosis of infectious diseases covering both marketing and scientific areas with bioMerieux, a French diagnostic company recognized as a world leader in microbiology. In July 1998, Gen-Probe formed an alliance with Chiron Corporation to enter the blood bank screening market with a combination assay for HIV and HCV utilizing TMA and the TIGRIS system. In October 1998, Gen-Probe received another $4.3 million grant from the NHLBI to develop a nucleic acid amplification test for HIV-2 and hepatitis B (HBV) virus for use in blood screening.

Gen-Probe's sister company, Chugai Biopharmaceuticals, Inc. (CBI) was established in 1995 to conduct basic discovery research and clinical development using state-of-the-art technologies. As a member of Chugai's Pacific Rim Research Network, CBI researchers collaborate with research scientists in Japan, Korea, and Australia and have access to Chugai's extensive toxicology and pharmaceutical development resources in developing novel therapeutics for the global pharmaceutical market. CBI's major area of focus is cardiovascular disease.

CBI's medium-term plan includes building a presence in the North American hospital markets by licensing in and developing later stage products in several therapeutic areas, including cardiovascular diseases and cancer. The company will also pursue tailoring its product portfolio to the needs of managed care. Gen-Probe and CBI expect to collaborate to create disease management programs for specific therapeutic areas.

The company has begun phase 2 clinical trials with a novel GI motility drug, GM-611, for the treatment of nonsurgical gastroparesis and gastroesophageal reflux disease.

And what does the future portend for Gen-Probe? The worldwide DNA probe market is expected to exceed $735 million by 2000. Gen-Probe is poised to capitalize on this market growth. The company's primary focus will remain where it can have the greatest impact on human health: developing and commercializing clinical diagnostics. Over the next five years Gen-Probe will expand its core offerings in the areas of sexually transmitted diseases (STDs) and respiratory diseases. It plans to develop and license new technologies and expand into areas such as cancer diagnosis, blood-virus screening and genetic testing. Research and development, the cornerstone of Gen-Probe's history, will continue to play a significant role in its future growth.

Gen-Probe's success has propelled it to the forefront among San Diego's biotech companies. As it enters the next century, Gen-Probe will continue to lead the way in offering innovative products that provide accurate diagnoses in time to make a difference.

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