Corporate History

Since its founding in 1983, Gen-Probe has been at the forefront of the molecular diagnostics industry. Major accomplishments in the Company's history include:

1983
  • Founded as a partnership by Dr. David E. Kohne, Dr. Thomas H. Adams, and Howard C. Birndorf.
1984
  • Incorporated in the State of California.
1985
  • Received first-ever FDA clearance for a clinical diagnostic test using DNA probe technology (culture confirmation test for Legionnaires' disease).
  • Introduced first product, a Mycoplasma tissue culture test in the U.S.
1986
  • Launched Legionella and Mycoplasma pneumoniae tests in the U.S.
1987
  • Completed Initial Public Offering (IPO), raised $16.2 million.
  • Reincorporated in Delaware.
  • Received FDA clearance for the world's first nonradioactive direct specimen genetic probe diagnostic test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infections.
  • Moved Corporate Headquarters into new 68,000 square foot facility.
1988
  • Negotiated $15.5 million R&D agreement with Chugai Pharmaceutical Company, Ltd.
  • Introduced world's first instrument reagent system to perform genetic probe diagnostics in a nonradioactive format.
  • Launched PACE® test, first-generation test kits for two prevalent sexually transmitted diseases, CT and GC infections. Marketed in the U.S. to identify these two pathogens from a single specimen in a matter of hours.
1989
  • Acquired by Chugai Pharmaceutical Co. Ltd. for $110 million.
  • Launched second generation of sexually transmitted disease products for detection of CT and GC.
  • Launched AccuProbe® culture identification products in the U.S.
  • First U.S. patent issued for detection methods targeting ribosomal RNA (rRNA), the technology on which the Company was founded.
  • Received FDA clearance to market first four AccuProbe Culture Identification tests.
  • Established second manufacturing facility to manufacture amplified products under development.
1990
  • Received FDA clearance to market 15 additional AccuProbe Culture Identification tests.
  • Completed development of target-amplified assay system capable of detecting a single microorganism in clinical samples.
1993
  • Launched AMPLIFIED Mycobacterium Tuberculosis Direct (MTD) test in Europe.
1994
  • Henry L. Nordhoff joined Gen-Probe as President and Chief Executive Officer.
  • Launched four new products in U.S.: Group A Streptococcus Direct Test (GASDIRECT®), PACE 2 Combo test for CT and GC, Probe Competition Assay confirmatory test for CT, and Probe Competition Assay confirmatory test for GC.
1995
  • U.S. patent for the Company's proprietary nucleic acid sequence amplification technology, TMA (Transcription-Mediated Amplification) issued.
1996
  • Awarded $7.7 million in contract funding from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to develop a nucleic acid test to screen donated blood for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV).
  • Launched AMPLIFIED MTD® Test in the U.S.; the first FDA approved nucleic acid amplification test for M. tuberculosis.
  • Launched AMPLIFIED Chlamydia test in Europe.
  • United States Patent and Trademark Office issued two patents expanding the scope of the Company's position in the area of nucleic acid amplification technologies.
1997
  • Opened 262,000-sq. ft. international headquarters at 10210 Genetic Center Drive.
  • Signed a collaborative agreement with bioMérieux in the field of molecular diagnosis of infectious diseases covering both technical and marketing areas.
  • Launched the AMPLIFIED Chlamydia test in the United States.
1998
  • Signed lease for new facility located at 10808 Willow Court in Rancho Bernardo to be used for manufacturing blood screening assays.
  • Formed a strategic alliance with Chiron Corporation to develop, manufacture and market nucleic acid probe assay systems for blood screening and certain areas of diagnostics.
  • Signed a manufacturing agreement for the TIGRIS™ Instrument System, a fully automated, high throughput, DNA probe system for blood screening and diagnostic applications.
  • Awarded additional $4.3 million contract from the NHLBI to develop a NAT assay for human immunodeficiency virus type 2 (HIV-2) and hepatitis B virus (HBV).
  • Established agreement with Bayer AG for viral diagnostics products.
1999
  • Together with Chiron Corporation, signed separate agreements with the American Red Cross and the America's Blood Centers to use Gen-Probe technology to test pooled samples of blood donations for infectious viruses, specifically HIV-1 and HCV.
  • Opened new state-of-the-art manufacturing facility to produce reagents that will be used to make the nation's blood supply as safe as the latest technology allows.
  • The FDA approved the AMPLIFIED Mycobacterium Tuberculosis Direct Test for the additional indication of diagnosing tuberculosis in smear-negative samples.
2000
  • Began work on a three-year $13.4 million cost sharing contract with the NHLBI, an arm of the NIH, to modify the HIV-1/HCV assay to incorporate hepatitis B virus detection capability in a single nucleic acid amplification assay.
2001
  • Received FDA clearance to market APTIMA Combo 2® Assay, a second-generation, amplified NAT assay for the simultaneous detection of CT and GC with equivalent performance with swab and urine samples.
2002
  • Received first FDA-license for the Company's PROCLEIX® assay to be used by blood banks to simultaneously detect human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV).
  • Launched the DTS™ 800 System for use in automated processing of the Gen-Probe APTIMA Combo 2 Assay.
  • On September 16, 2002, the Company began "regular-way" trading under the ticker symbol "GPRO" following its spin-off from Chugai Pharmaceutical.
  • Received FDA approval for the Company's qualitative HCV Assay, marketed by Bayer Diagnostics as the VERSANT® HCV RNA Qualitative Assay.
  • Received $1.0 million in contract funding from the NHLBI to initiate development of a nucleic acid test for West Nile virus.
2003
  • Nucleic acid test for West Nile virus became available for use by U.S. Blood Centers under an investigational new drug application.
  • Acquired Molecular Light Technology Limited (MLT), a UK-based company that developed the technology which forms the basis of Gen-Probe's chemiluminescent Hybridization Protection Assay ("HPA") detection technology
  • Completed two-for-one-stock split in the form of a 100 percent stock dividend for shares held on the record date of September 16, 2003.
  • Received $6.8 million of supplemental contract funding from the NHLBI to pursue clinical studies and regulatory approval of a nucleic acid test to detect West Nile virus in donated blood and organs.
  • Gen-Probe and Chiron amended blood screening collaboration agreement with Gen-Probe's share of net revenues set at 45.75% for assays that include a test for HCV.
  • Entered into agreement with Canadian Based DiagnoCure to develop a molecular urine test for the PCA3 gene to detect prostate cancer.
  • Received FDA approval for sexually transmitted disease testing on the fully automated TIGRIS® DTS® system. The TIGRIS system was approved to run the APTIMA COMBO 2® assay.
2004
  • PROCLEIX® ULTRIO® Assay used for the simultaneous detection of human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood receives European CE mark.
  • Received FDA approval for the APTIMA® Vaginal Swab Specimen Collection Kit, which enables patients to self-collect vaginal swab specimens to be tested for Chlamydia trachomatis and Neisseria gonorrhoeae.
  • Signed licensing agreements with bioMérieux that provide bioMérieux options to access Gen-Probe's ribosomal RNA technologies for certain uses, and that give Gen-Probe access to bioMérieux's intellectual property for detecting genetic mutations that predispose people to blood clotting disorders.
  • Settled patent dispute with Vysis, acquiring paid-up license on future sales of amplified products.
  • Acquired from Qualigen the rights to develop a point-of-use nucleic acid testing instrument based on Qualigen's FDA-approved FastPack® immunoassay system.
  • Received European CE mark for the fully automated PROCLEIX® TIGRIS® System for use with the PROCLEIX® ULTRIO® Assay.
2005
  • Signed agreement with Roche to purchase products for use in APTIMA® human papillomavirus assay.
  • U.S. Food and Drug Administration (FDA) granted marketing clearance for the Company's standalone APTIMA® assay for Neisseria gonorrhoeae (GC).
  • An arbitrator determined that Gen-Probe is entitled to a co-exclusive right to distribute qualitative TMA assays to detect the hepatitis C virus and HIV-1. Bayer previously held the exclusive rights to market these products.
  • Gen-Probe was issued U.S. Patent No. 6,890,742, which broadly claims an automated process for isolating and amplifying a target nucleic acid sequence within a closed system.
  • Formed collaboration with GE Infrastructure, Water & Process Technologies to develop, manufacture and NATs to detect the unique genetic sequences of microorganisms in selected water applications.
  • Received US marketing clearance to use the APTIMA Combo 2® assay to test for Chlamydia trachomatis and Neisseria gonorrhoeae from liquid Pap specimens collected and processed with Cytyc's ThinPrep® 2000 System.
  • Formed an alliance with Millipore to develop, manufacture and commercialize (NAT) products for rapid microbiological and virus monitoring in the biotech and pharmaceutical industries.
  • President George W. Bush named Gen-Probe a 2004 National Medal of Technology Laureate in recognition of the Company's pioneering work in developing innovative nucleic acid tests to safeguard the nation's donated blood supply from viruses such as HIV-1 and the hepatitis C virus. The National Medal of Technology is the nation's highest honor for technological innovation.
  • The U.S. FDA granted marketing approval to use the Company's PROCLEIX® West Nile virus (WNV) assay to screen donated human blood on the PROCLEIX enhanced semi-automated instrument system (eSAS).
2006
  • Licensed from the University of Michigan the exclusive worldwide rights to develop diagnostic tests for recently discovered genetic translocations that have been shown in preliminary studies to be highly specific for prostate cancer.
  • Exercised option to develop a novel nucleic acid testing platform based on Qualigen's immunoassay system. Purchased preferred stock convertible into approximately 19.5% of Qualigen's fully diluted common shares for $7 million.
  • Agreed to end a series of disputes with Bayer involving multiple patent litigations and contract arbitrations. Bayer will pay Gen-Probe lump sum royalties over the next 18 months.
  • FDA granted marketing approval for the PROCLEIX ULTRIO assay to run on the enhanced semi-automated instrument system, or eSAS. The assay was approved to screen donated blood for HIV-1 and hepatitis C virus, but not for hepatitis B virus (HBV). Announced plans to initiate a post-marketing study to demonstrate HBV yield and gain a donor-screening claim for HBV.
  • FDA granted marketing approval for the APTIMA HIV-1 RNA qualitative assay.
  • FDA granted marketing clearance to run the Company's standalone APTIMA assays for CT and GC on the TIGRIS system, and to use the APTIMA Combo 2 assay to test certain liquid Pap and vaginal swab specimens on the TIGRIS system.
  • Received U.S. Patent No. 7,118,892, which extends the Company's intellectual property estate relating to integrated instrument systems for nucleic acid testing.
  • FDA granted marketing clearance to use the Company's standalone APTIMA assays for CT and GC to test certain liquid Pap specimens on the TIGRIS system.
  • Formed an exclusive worldwide collaboration with 3M to develop, manufacture and market nucleic acid tests to enhance food safety.
  • Announced the European commercial launch of the PROGENSA® PCA3 assay, a new prostate cancer-specific molecular diagnostic test.
2007
  • Carl Hull joined the Company as executive vice president and chief operating officer.
  • FDA approved PROCLEIX® TIGRIS® System, the first fully automated molecular diagnostics instrument, to screen donated blood, organs and tissues for West Nile virus (WNV) using the PROCLEIX WNV Assay.
  • Formed an exclusive worldwide collaboration with 3M to develop and commercialize rapid, easy-to-use nucleic acid tests to detect certain dangerous healthcare-associated infections such as methicillin-resistant Staphylococcus aureus (MRSA).
  • FDA approved the TIGRIS® system for blood screening use with the PROCLEIX ULTRIO® assay.  The system was approved to screen donated blood for HIV-1 and HCV, but not HBV.
  • Discontinued molecular food testing collaboration with 3M.
2008
  • Partner Millipore launched the first real-time molecular test for detecting microbial contamination in biopharmaceutical applications.
  • Carl Hull named president and chief operating officer.
  • Launched CE-marked APTIMA HPV assay in Europe.
  • Launched cash tender offer to acquire Belgian molecular diagnostics company Innogenetics; withdrew offer approximately one month later following higher bid made by Solvay.
  • 3M discontinued collaboration with Gen-Probe to develop molecular tests for healthcare-associated infections.
  • FDA granted full approval to use the PROCLEIX ULTRIO assay to screen donated blood for HIV-1, HCV and HBV on the TIGRIS system.
  • Board of directors approved $250 million stock repurchase plan.
2009
  • Agreed to extend and expand blood screening collaboration with Novartis.  New agreement, which runs through 2025, provides Gen-Probe increased share of economics over time and funding for PANTHER development in blood screening.
  • Carl Hull elected chief executive officer; Hank Nordhoff becomes chairman of the board.
  • Acquired Tepnel Life Sciences, fast-growing European molecular diagnostics company with significant transplant diagnostics business, for approximately $136 million in cash.
  • Broadened intellectual property portfolio around automated nucleic acid testing through seven additional patents granted by US and European patent authorities.
  • Began US clinical studies of PROGENSA PCA3 and APTIMA trichomonas studies.
  • Consolidated industrial testing assets and collaborations into new, independent company, Roka Bioscience.
  • Acquired Prodesse, leader in molecular testing for respiratory infectious diseases, for $60 million cash plus potential milestone payments.
  • FDA granted Emergency Use Authorization for Prodesse’s ProFlu-ST assay, which detects 2009 H1N1 influenza virus and two other seasonal influenza A strains.
  • FDA cleared Prodesse’s ProParaflu+ assay, which detects parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections.
PACE, ACCUPROBE, AMPLIFIED MTD, APTIMA, APTIMA COMBO 2, TIGRIS, DTS, AND GASDIRECT are trademarks of Gen-Probe Incorporated

PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc.

THINPREP is a trademark of Cytyc, a Hologic Company.


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Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121
USA

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