Corporate History

Since its founding in 1983, Gen-Probe has been at the forefront of the nucleic acid 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 very 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

Gen-Probe 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 Company's core technology.
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 fifteen 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 (in July).
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.
Signed License Agreement granting Becton Dickinson and Company a non-exclusive worldwide right and license to Gen-Probe's U.S. Patents Nos. 4,851,330 and 5,288,611 as they relate to methods for detecting Candida species, Gardnerella vaginalis, and Trichomonas vaginalis for diagnosing vaginosis and vaginitis.

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 the Gen-Probe Transcription-Mediated Amplification System 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.
Signed agreement with Ambion for non-exclusive worldwide rights to use its Armored RNA^® technology in products and processes for human clinical diagnostic use.
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 that will screen the blood of potential organ donors.

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 amplified NAT assay to be used by blood banks to simultaneously detect human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV). The combination HIV-1/HCV test system, developed and manufactured by Gen-Probe, is marketed worldwide by Chiron Corporation as the PROCLEIX^® HIV-1/HCV Assay.
Launched the DTS™ 800 System for use in automated processing of the Gen-Probe APTIMA Combo 2 Assay. The new DTS 800 system offers alternative for low- to mid-volume laboratory customers.
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. It is the most sensitive assay to be approved for qualitative detection of HCV and is 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 to begin clinical testing for the virus in freshly donated human blood under an investigational new drug application.
Acquired Molecular Light Technology Limited (MLT). MLT is a UK-based biotechnology 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 National Heart, Lung, and Blood Institute of the NIH to continue development and pursue clinical studies and submission of a Biologics License Application (BLA) for 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. The PCA3 gene has been shown to be over-expressed in malignant prostate tissue. The test will be marketed by Gen-Probe.
Initiated US clinical trials for the PROCLEIX^® ULTRIO^® Assay on the semi-automated instrumentation system for the simultaneous detection of HIV-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissue.
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 now bears the CE (Conformite Europeenne) Mark in accordance with Directive 98/79/EC. The PROCLEIX ULTRIO Assay is the first CE-Marked triplex nucleic acid test (NAT) for blood screening.
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.
Initiated clinical trials of PROCLEIX^® ULTRIO^® Assay on the PROCLEIX^® TIGRIS^® System for the simultaneous detection of HIV-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissue.
Initiated testing with the PROCLEIX^® West Nile Virus (WNV) Assay under an investigational protocol on the PROCLEIX^® TIGRIS^® System.
Signed non-exclusive licensing agreements with bioMérieux and its affiliates 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.
Submitted a U.S. Biologics License Application for the PROCLEIX^® ULTRIO^® Assay to the FDA. The PROCLEIX ULTRIO Assay adds a test for hepatitis B Virus (HBV) to the previously approved PROCLEIX^® HIV-1/HCV Assay.
Acquired from Qualigen the rights to develop a point-of-use nucleic acid testing instrument based on Qualigen's FDA-approved FastPack^® immunoassay system.
Recevied CE (Conformité Européene) Mark approval for the fully automated PROCLEIX^® TIGRIS^® System for use with the PROCLEIX^® ULTRIO^® Assay. The CE mark will clear the way for commercialization of the system in the European Untion and other parts of the world.

2005

Licensed technology from AdnaGen, a private company based in Germany, that may help increase the accuracy of molecular diagnostic tests to detect prostate and other cancers, help determine the aggressiveness of these malignancies, and monitor responses to therapy.
Licensed from Corixa the rights to develop molecular diagnostic tests for potential genetic markers in the areas of prostate, ovarian, cervical, kidney, lung and colon cancer.
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. The new patent complements nine others previously issued to Gen-Probe related to automated nucleic acid testing systems and components.
GE Infrastructure, Water & Process Technologies, a unit of General Electric Company and Gen-Probe will work together on an exclusive basis to develop, manufacture and commercialize nucleic acid testing (NAT) technologies that are designed to detect the unique genetic sequences of microorganisms in selected water applications.
U.S. Food and Drug Administration (FDA) granted marketing clearance to use Gen-Probe's 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.
Millipore and Gen-Probe formed an alliance to develop, manufacture and commercialize on an exclusive basis nucleic acid testing (NAT) products for rapid microbiological and virus monitoring in the biotech and pharmaceutical industries. Microbiological monitoring of manufacturing processes is critical to ensuring patient safety and meeting regulatory requirements.
The U.S. Food and Drug Administration (FDA) notified Gen-Probe that it considers the PROCLEIX^® TIGRIS^® system “not substantially equivalent” to the PROCLEIX enhanced semi-automated system (eSAS) for screening donated human blood with the PROCLEIX^® ULTRIO^® assay.
The U.S. Food and Drug Administration (FDA) verbally advised the Company that it will have additional questions regarding Gen-Probe's Biologics License Application (BLA) for the PROCLEIX^® ULTRIO^® assay.
Formed a non-exclusive collaboration with the Molecular Profiling Institute Inc., a private, specialty reference laboratory, to accelerate market development for Gen-Probe's pipeline of novel cancer diagnostics.
President George W. Bush named Gen-Probe Incorporated 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. Food and Drug Administration (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. Under the terms of the agreement, Bayer will pay Gen-Probe certain 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. The assay may be used as an aid in the diagnosis of acute and primary HIV-1 infection, and to confirm HIV-1 infection in an individual whose specimen is repeatedly positive for HIV-1 antibodies.
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 innovative nucleic acid tests to enhance food safety and increase the efficiency of testing for food manufacturers.
Announced the European commercial launch of the PROGENSA™ PCA3 assay, a new prostate cancer-specific molecular diagnostic test. The PCA3 test has been CE marked, allowing it to be marketed in the European Union.

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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