Timeline of PCR and Roche 

Polymerase chain reaction (PCR) is a Nobel-prize winning technology used to amplify, or copy on a large scale, specific sequences of genetic material, called Deoxyribonucleic Acid, or DNA. The importance of this technology has moved far beyond its initial purpose of enabling the detailed analysis of DNA for molecular biology applications and gene sequencing. Today PCR plays an active role in disciplines as varied as archeology, forensics, genetics, histopathology and medicine.

1983

  • Dr. Kary Mullis at Cetus Corporation conceives of Polymerase Chain Reaction (PCR). PCR is a simple yet elegant process that enables the production of virtually unlimited copies of genetic material in the laboratory.
  • Although the Nobel Prize for the conception of PCR was given to Kary Mullis, Ph.D., in 1993, the technology was developed and applied by the labs of Henry Erlich, Ph.D., David Gelfand, Ph.D., and other teams of scientists at Cetus. The full history of the technology’s development and application is marked by an extraordinary collaboration of scientists working in a corporate setting, working together to identify and overcome the obstacles to the practical use of PCR for DNA analysis in research and medicine.

1985

  • Cetus files first PCR patent application.
  • First publication of PCR by Cetus Corporation appears in Science. This is the original publication that first describes the PCR process, amplification of human beta-globin genes and application to clinical diagnosis.

1986

  • Purified Taq polymerase is first used in PCR as a replacement to Klenow.
  • First forensic use of DNA typing of HLA-DQA locus using PCR in United States.

1987

  • Cetus is awarded fundamental patents for PCR.

1988

  • PerkinElmer introduces the automated thermal cycler.
  • Science prints first published description of PCR with thermostable polymerase.
  • First post-conviction review using PCR on a forensic specimen.

1989

  • Science declares Taq polymerase "molecule of the year.
  • Introduction of AmpliTaq DNA Polymerase (first cloned recombinant Taq DNA polymerase).
  • Hoffmann-La Roche Inc. and Cetus agree to begin joint development of diagnostic applications for PCR.

1990

  • First forensic PCR kit is introduced for HLA-DQA, a polymorphic genetic locus useful for human individual identification.
  • Dr. D. Gelfand and Ms. S. Stoffel named Distinguished Inventors for purifying Taq DNA polymerase.
  • Drs. H. Erlich and K. Mullis receive the Biochemical Analysis Award from the German Society of Clinical Chemistry.
  • Scientists achieve the first simultaneous amplification and detection of specific DNA sequences using a fluorescent DNA-binding dye, laying the foundation for future "real-time" or "kinetic" PCR (TaqMan® tests).

1991

  • RT-PCR is developed using a single thermostable polymerase, rTth, facilitating diagnostic tests for RNA viruses.
  • First publication on rTth and launch of first thermostable RT-PCR research kit.
  • First publication describing the technology allowing simultaneous amplification and detection of genetic material. later incorporated into TaqMan® tests and instruments.
  • Dr. H. Erlich receives the Advanced Technology in Biotechnology (ATB'91) Milano Award from the International Federation of Clinical Chemistry.
  • Hoffmann-La Roche Inc. acquires worldwide rights and patents to PCR.
  • Roche Molecular Systems, Inc. (informally called Roche Molecular Diagnostics, or RMD) is founded exclusively to develop diagnostic and other tests utilizing PCR technology.

1992

  • AMPLICOR® Chlamydia trachomatis Test (CT) and AMPLICOR® HIV-1 MONITOR Test are introduced outside of the United States.

1993

  • AMPLICOR® HCV MONITOR Test is introduced outside of the United States.
  • AMPLICOR® CT Test receives 510K clearance by the United States Food and Drug Administration (FDA) and launches in the United States, making it the first FDA-cleared PCR test.
  • Dr. Kary Mullis shares Nobel Prize in Chemistry for conceiving PCR technology.

1994

  • Japanese Red Cross and RMS form partnership to initiate PCR-based testing for screening donated blood for HIV, HCV and HBV.
  • rTth EZ RT-PCR research kit launches.
  • Tth XL [Extra Long] DNA PCR research kit launches.
  • The first in a series of U.S. patents is issued to RMS inventors for thermostable reverse transcriptase.

1995

  • COBAS® AMPLICOR Analyzer, the first automated system for routine diagnostic PCR, launches outside of the United States.
  • AMPLICOR® HIV-1 MONITOR Test and AMPLICOR® HCV MONITOR Test, the first standardized "quantitative" PCR kits, launch outside of the United States.
  • AMPLICOR® CT/NG "multiplex" test launches outside of the United States.
  • AmpliTaq GOLD DNA polymerase launches, featuring the "Hot Start" form of the enzyme.
  • Introduction of AmpliTaq DNA polymerase FS (the enzyme that sequenced the Human Genome).

1996

  • Introduction of an internal control in AMPLICOR® CT/NG Test.
  • FDA approves AMPLICOR® HIV-1 MONITOR Test.
  • FDA clears AMPLICOR® MTB Test for detecting Mycobacterium tuberculosis (MTb) DNA.
  • RMS scientists describe the first ribonucleotide-incorporating thermostable "designer" DNA Polymerase and "PCR ribo-sequencing."
  • Dynal launches DRB-29 HLA-typing kit for tissue typing.

1997

  • FDA clears COBAS® AMPLICOR Analyzer; product is launched in the United States.

1998

  • FDA clears COBAS® AMPLICOR Analyzer for clinical use.
  • FDA approves COBAS® AMPLICOR Chlamydia trachomatis Detection Test.
  • Dynal launches DQB1-25, HLA B-56 and HLA A-35 HLA-typing kits for use in transplantation tissue typing.

1999

  • FDA approves AMPLICOR® HIV-1 MONITOR UltraSensitive Test and clears COBAS® AMPLICOR CT/NG Test.
  • U.S. blood centers implement nucleic acid technology (NAT) testing for HCV and HIV, using COBAS® AmpliScreen HIV-1 Test and COBAS® AmpliScreen HCV Test under an Investigational New Drug (IND) application.
  • Dr. Tom White is presented with Caregiver Award from the AIDS Healthcare Foundation.
  • Japanese Red Cross Society implements NAT testing to screen 100 percent of donated blood for HIV, HCV and HBV using AmpliNAT MPX system.
  • U.S. patent awarded to RMD inventors for thermostable ribonucleotide incorporating "designer" DNA Polymerase.
  • U.S. patent awarded ("the '056 patent") to RMD inventors for the method of monitoring nucleic acid amplification reactions using a dye-based, probeless process of simultaneous PCR amplification, detection and quantitation ("real-time PCR" or "kinetic PCR").
  • Dynal launches DRB-36 HLA-typing kit for tissue typing.
  • LightCycler® TeloTAGGG hTERT Quantification Kit launches.

2000

  • National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) awards three-year, $1.2 million grant for development of SNP genotyping program using kinetic thermocycler technology.
  • Dr. Henry Erlich receives Association for Molecular Pathology's "Award for Excellence" and National Institute of Justice "Profiles in DNA Courage" Award.
  • Agreement reached between Roche and Chiron regarding a broad patent license for probe-based clinical diagnostics for HCV and HIV-1.
  • LightCycler® TeloTAGGG hTR Quantification Kit launches.
  • Dynal launches HLA C-34 typing kit for tissue typing.
  • Roche's LinearArray CF Gold, a cystic Fibrosis mutation-detection product, is launched as an Analyte Specific Reagent in the United States.
  • Cystic Fibrosis mutation-detection Analyte Specific Reagent launches.
  • First publication of the descriptions of "designer" DNA Polymerase with magnesium-activated thermostable reverse transcriptase activity, as well as the first thermostable reverse transcriptase with proofreading activity.

2001

  • U.S. patent awarded ("the '785 patent") to RMD inventors for a fiber-optic-based PCR device to simultaneously amplify, detect and quantitate nucleic acids ("real-time PCR" or "kinetic PCR").
  • COBAS® AmpliPrep System launches outside of the United States for research use.
  • COBAS® AmpliScreen HCV and HIV Test kits launch outside of the United States for use in blood screening.
  • Roche and Chiron Corporation reach agreement on licensing terms for use of HIV-1 and HCV intellectual property for NAT testing to screen blood, plasma and blood products intended for transfusion.
  • FDA approves AMPLICOR® HCV Test 2.0 and COBAS® AMPLICOR HCV Test 2.0.
  • Launch of TaqMan® HCV Analyte Specific Reagent in the United States.

2002

  • FDA clears Roche's next generation automated PCR system, the COBAS® TaqMan® Analyzer, Series 96, for commercial use in the United States.
  • COBAS® AmpliScreen HIV-1 Test, v1.5 receives registration in Italy.
  • Manufacture of 4,000th COBAS® AMPLICOR Analyzer.
  • FDA approves AMPLICOR® HIV-1 MONITOR Test, version 1.5, a test with the ability to measure HIV-1 RNA down to 50 copies/mL and the ability to detect and quantify non-B HIV subtypes (Group M subtypes A - G).
  • Roche receives FDA clearance for the COBAS® AmpliScreen System for use in laboratories testing plasma specimens in the blood screening market. The system automates the sample dilution and pooling procedures as well as the amplification and detection steps for analysis of specimens using the PCR-based nucleic acid amplification methods.
  • FDA approves the COBAS® AmpliScreen HCV Test, v2.0 and the COBAS® AmpliScreen HIV-1 Test, v1.5, the first two blood screening tests designed for use with the COBAS® AmpliScreen System. The FDA approves Roche's Blood Licensing Applications (BLAs) for these tests in record time. FDA also clears the COBAS® AmpliScreen Data Output Management System (DOMS) for use with the COBAS® AmpliScreen System.
  • FDA grants an Investigational New Drug Application (IND) for the COBAS® AmpliScreen HBV Test in July 2002. In August, Roche begins clinical trials of this test.
  • Roche sponsors two-year surveillance program in the U.K. to help ensure future performance of industry's HIV viral load assays.
  • Roche Diagnostics and Qiagen partner to develop and commercialize an integrated diagnostic system for hepatitis and HIV PCR testing.
  • Roche Diagnostics acquires broad Human Papillomavirus (HPV) patent portfolio from the Institut Pasteur.
  • Roche and Innogenetics announce the launch of a first series of new microbiology tests, resulting from the co-operation between the two companies.
  • Launch of TaqMan® HBV Analyte Specific Reagent in the United States.

2003

  • Roche's HIV-1 MONITOR Test, version 1.5 Product Family, the automated version of the AMPLICOR® HIV-1 MONITOR Test, version 1.5 is approved for use in Europe as a CE IVD Product.
  • Roche's HCV MONITOR version 2.0 Product Family, for the quantitation of hepatitis C virus (HCV) RNA in human serum or plasma, is approved for use in Europe as a CE IVD Product.
  • Roche's HCV version 2.0 Product Family, qualitative tests for hepatitis C virus (HCV) RNA in human serum or plasma, is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® AmpliPrep/COBAS® AMPLICOR HCV Test, version 2.0, a quantitative nucleic acid amplification test for detection of hepatitis C virus (HCV) RNA in human serum or plasma is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® AMPLICOR HBV MONITOR Test, for the automated amplification and quantitation of hepatitis B virus (HBV) DNA in human plasma and serum, on the COBAS® AMPLICOR Analyzer, is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® AMPLICOR CMV MONITOR Test, for the automated amplification and quantitation of Human Cytomegalovirus (CMV) DNA in human plasma, is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® AmpliScreen Product Family, blood screening tests for the automated amplification and detection of HBV DNA, HCV RNA and HIV-1 RNA, in human plasma, from donations of whole blood and blood components for transfusion, is approved for use in Europe as a CE IVD Product.
  • Roche's AMPLICOR® CT/NG Test for Chlamydia trachomatis, a microwell plate format test the amplification and detection of Chlamydia trachomatis in human samples, is approved for use in Europe as a CE-IVD Product.
  • Roche's AMPLICOR® CT/NG Test for Neisseria gonorrhoeae, a microwell plate format test for detection of Neisseria gonorrhoeae in human samples, is approved for use in Europe.
  • Roche's COBAS® AMPLICOR Chlamydia trachomatis Test, for automated amplification and detection of Chlamydia trachomatis in human samples, is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® AMPLICOR Neisseria gonorrhoeae Test, for automated amplification and detection of Neisseria gonorrhoeae in human samples, is approved for use in Europe.
  • Roche's COBAS® TaqMan® HIV-1 Test, a nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human EDTA plasma, is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® TaqMan® HBV Test, a nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human serum or plasma, is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® TaqMan® HCV Test, a nucleic acid amplification test for the quantitation of hepatitis C virus (HCV) RNA in human serum or plasma, is approved for use in Europe as a CE IVD Product.
  • Roche's AMPLICOR® MTB Test and COBAS® AMPLICOR MTB Test, a microwell plate format test and an automated test, respectively, for the amplification and detection of Mycobacterium tuberculosis, are approved for use in Europe.

2004

  • Roche's AMPLICOR® HPV Test, for the detection of Human Papilloma Virus (HPV) in cervical cells, is approved for use in Europe as a CE IVD Product.
  • Roche's COBAS® TaqMan® HBV Test for the quantitation of hepatitis B virus (HBV) DNA in human serum or plasma using the High Pure System Viral Nucleic Acid Kit for manual specimen preparation, is approved for use in Japan.
  • The FDA approves the COBAS® AmpliPrep/COBAS® AMPLICOR HCV Test, v2.0, for automated sample preparation, amplification and detection of HCV RNA, as a PMA Supplement to the COBAS® AMPLICOR HCV Test, v2.0.
  • Roche's AmpliChip CYP450 Test, for the identification of a patient's CYP2D6 and CYP2C19 genotypes and predictive phenotypes (poor, intermediate, extensive or ultra-rapid metabolizer), is available for use in Europe as a CE IVD Product.
  • The FDA clears the AmpliChip CYP450 Test for analysis of the CYP2D6 gene, one of two genes analyzed as part of the test. The product is the first microarray-based test, and first pharmacogenomic test, to receive clearance for diagnostic use in the United States.

2005

  • FDA clears the AmpliChip CYP450 Test for analysis of the CYP2C19 gene, one of two genes analyzed as part of the test. The product is the first microarray-based test, and first pharmacogenomic test, to receive clearance for diagnostic use in the United States.
  • Roche's COBAS® TaqMan® HIV-1 Test, for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human EDTA plasma is approved for use in Japan.
  • Roche receives FDA approval for the COBAS® AmpliScreen HBV Test, a blood screening test for the automated amplification and detection of HBV DNA.
  • Roche receives FDA approval for the COBAS® AmpliPrep/COBAS® AMPLICOR HIV-1 MONITOR Test, v1.5, for the automated sample preparation, amplification and quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma.
  • Roche's COBAS® AmpliPrep/COBAS® TaqMan® HIV, HCV, and HBV Tests, for the automated sample preparation, amplification and quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA, hepatitis C virus, and hepatitis B virus (HBV) respectively, are approved for use in Europe as CE IVD Products.
  • Roche's LINEAR ARRAY® HCV Genotyping Test, v2.0, for use with the AMPLICOR® and COBAS® AMPLICOR HCV Tests, for determining the genotype (GT-1-GT-6) of hepatitis C virus (HCV), in patients with chronic HCV infection, is approved for use in Europe as a CE IVD Product.
  • Roche's LINEAR ARRAY® HPV Genotyping Test, for the detection of Human Papilloma Virus in cervical cells, is approved for use in Europe.
  • Roche's COBAS® TaqMan® CT Test, for the automated amplification and detection of Chlamydia trachomatis DNA in human samples, is approved for use in Europe as a CE IVD Product.
  • Roche's LightCycler® SeptiFast Test (M), and LightCycler® SeptiFast mecA Test (M), for the detection and identification of bacterial and fungal DNA in human K-EDTA blood, using the LightCycler® v2.0 Instrument, is approved for use in Europe.

2006

  • Roche receives FDA clearance for the COBAS® AMPLICOR CT/NG Test for detection of Chlamydia trachomatis in human samples prepared with the Tecan sample preparation system.
  • Roche receives FDA clearance for the COBAS® AMPLICOR CT/NG Test for detection of Neisseria gonorrhoeae in human samples prepared with the Tecan sample preparation system.
  • Roche's cobas TaqScreen MPX Test, for use on the cobas s 201 system, a blood donor screening test for the simultaneous detection of HIV-1 Group M and Group O RNA, HIV-2 RNA, HCV RNA and HBV DNA, in human plasma, is approved for use in Europe as a CE IVD Product.

2007

  • Roche receives FDA approval for the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test for the automated sample preparation, amplification and quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma.
  • Roche receives FDA approval for the cobas TaqScreen West Nile Virus Test, which tests for direct detection of West Nile Virus in donated human blood and plasma.
  • The Japanese Red Cross selects Roche as supplier for next-generation nucleic acid screening of the country’s 5 million annual blood donations. The tests use Roche’s fully integrated and automated cobas s 401 instrument with the cobas TaqScreen MPX Test.

2008

  • Roche announces that its new test for detection of Chlamydia trachomatis has received CE Mark certification, allowing it to be sold for clinical use in the European Union.
  • The FDA approves the Roche COBAS® TaqMan® HBV Test, the first assay for quantitating Hepatitis B Virus DNA approved in the U.S.
  • Roche announces that the FDA has approved the COBAS® AmpliPrep / COBAS® TaqMan® HCV Test for use in the United States.
  • Roche announces that it has received CE Mark certification for its new COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0, allowing it to be sold for clinical use in the European Union.
  • The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 receives the CE Mark certification, allowing it to be sold for clinical use in the European Union. The Roche test utilizes a unique design to simultaneously amplify and detect two separate regions of the HIV-1 genome.
  • The FDA approves the cobas TaqScreen MPX Test for use on the cobas s 201 system. It is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma.

2009

  • A Roche test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) becomes available with the CE Mark. The LightCycler® MRSA Advanced Test is a qualitative in vitro diagnostic test for the direct detection of nasal colonization with MRSA.
  • Roche introduces new cobas p 630 Instrument and AMPLILINK 3.3 Series Software with CE Mark. It is the only pre-analytical instrument that unites primary tube handling with fully automated sample preparation, amplification and detection for molecular diagnostics.
  • FDA approves use of Roche's cobas® TaqScreen MPX Test to screen source plasma for HIV, hepatitis B virus and hepatitis C virus. The test detects multiple viruses for increased plasma product safety.
  • Roche introduces a new automated clinical laboratory system for CE-Marked testing of human papillomavirus, Chlamydia and N. gonorrhoeae. The cobas 4800 System is designed to increase laboratory efficiency and medical value.

2010

  • FDA approves the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0, a dual-PCR target HIV-1 viral load test to quantify the amount of virus in a patient's blood. It is the first quantitative viral load test to amplify and detect two separate regions of a target genome.
  • The LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) is cleared by the FDA for clinical use in the United States. The test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with bacterial MRSA.
  • Roche announces FDA approval of the COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0 for use in the U.S. The test provides an automated solution for the quantitative detection of hepatitis B virus DNA in human plasma or serum for patients on HBV antiviral therapy.
  • The cobas® TaqScreen DPX Test for use on the cobas s 201 System becomes available with the CE Mark. It is the first IVD test to offer complete coverage of all human genotypes of parvovirus B19 (B19V) and hepatitis A virus (HAV) in one assay.
  • Roche announces FDA approval of the real-time PCR COBAS® TaqMan® HCV Test, v2.0. This HCV quantitative test is key to measuring the effectiveness of many antivirals that are currently in clinical development for the treatment of hepatitis C.

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