PCR (Plymerase Chain Reaction) - From 1983 to 2006- A Chronological Sequence
Polymerase Chain Reaction (PCR) is a Nobel-prize winning nucleic acid amplification technology that allows minute amounts of genetic material to be amplified into billions of copies in just a few hours.
It has enabled many significant advances in the Genome projects, DNA fingerprinting and in the diagnosis and monitoring of diseases such as AIDS and hepatitis. Beyond its wide medical applications, PCR has been used to help in our understanding of evolution, human migration and even for use in food safety, archaeology and forensics.
In 1983, Dr. Kary Mullis at Cetus Corporation conceived 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. For the conception of PCR, the Nobel Prize in Chemistry was awarded to him in 1993.
In 1985, Cetus filed the first PCR patent application. The same year, the first publication of PCR by Cetus Corporation appeared in Science. This is the original publication that first describes the PCR process, amplification of human beta-globin genes and application to clinical diagnosis.
In 1986, purified Taq polymerase was first used in PCR as a replacement to Klenow. The same year saw the first forensic use of DNA typing of HLA-DQA locus using PCR in United States.
Cetus was awarded fundamental patents for PCR in 1987.
In 1988, the automated thermal cycler was introduced by Perkin Elmer. Science printed the first published description of PCR with thermostable polymerase. Also in this year came the first post-conviction review using PCR on a forensic specimen.
In 1989, Taq polymerase was declared "molecule of the year" by Science. The same year, Hoffmann-La Roche Inc. and Cetus began joint development of diagnostic applications for PCR.
The first forensic PCR kit was introduced for HLA-DQA, a polymorphic genetic locus useful for human individual identification in 1990.
The year 1991 saw the development of RT-PCR, which uses a single thermostable polymerase, rTth, facilitating diagnostic tests for RNA viruses; and the first publication on rTth followed by the launch of the first thermostable RT-PCR research kit. Hoffmann-La Roche Inc. acquired worldwide rights and patents to PCR. Roche Molecular Systems, Inc. (informally called Roche Molecular Diagnostics, or RMD) was founded exclusively to develop diagnostic and other tests utilizing PCR technology.
Several such tests were developed (for details refer http://molecular.roche.com/roche_pcr/pcr_timeline.html).
In 1994, Japanese Red Cross and RMS formed a partnership to initiate PCR-based testing for screening donated blood for HIV, HCV and HBV.
In 1995, automated systems for routine diagnostic PCR, standardized "quantitative" PCR kits and AMPLICOR® CT/NG "multiplex" test were launched outside USA.
1996 saw the AMPLICOR® MTB Test for detecting Mycobacterium tuberculosis (MTb) DNA obtain clearance from FDA. The same year, RMS scientists described the first ribonucleotide-incorporating thermostable "designer" DNA Polymerase and "PCR ribo-sequencing." Dynal launched DRB-29 HLA-typing kit for tissue typing.
In 1998, FDA cleared COBAS® AMPLICOR Analyzer for clinical use and approved COBAS® AMPLICOR Chlamydia trachomatis Detection Test.
Dynal launched DQB1-25, HLA B-56 and HLA A-35 HLA-typing kits for use in transplantation tissue typing.
In 1999, U.S. blood centers implemented 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. Japanese Red Cross Society implemented NAT testing to screen 100% of donated blood for HIV, HCV and HBV.
U.S. patent was awarded to RMD inventors for thermostable ribonucleotide incorporating "designer" DNA Polymerase and 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 launched DRB-36 HLA-typing kit for tissue typing.
In 2000, National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) awarded three-year, $1.2 million grant for development of SNP genotyping program using kinetic thermocycler technology to Drs. Gary Peltz, Roche Bioscience (now Roche Palo Alto) and Russell Higuchi of RMD. Dynal launched HLA C-34 typing kit for tissue typing.
In 2001, U.S. patent was 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"). The same year, AmpliTaq GOLD DNA polymerase was launched, featuring the "Hot Start" form of the enzyme and AmpliTaq DNA polymerase FS (the enzyme that sequenced the Human Genome)was introduced. Roche and Chiron Corporation reached 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. The first draft of human genome was published.
In 2002, Roche received 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. Roche Diagnostics acquired broad Human Papillomavirus (HPV) patent portfolio from the Institut Pasteur. Roche and Innogenetics announced the launch of a first series of new microbiology tests, resulting from the co-operation between the two companies.
In 2003, the Human Genome Project was completed. Roche's AMPLICOR® CT/NG Test for Neisseria gonorrhoeae, a microwell plate format test for detection of Neisseria gonorrhoeae in human samples, and Roche's COBAS® AMPLICOR Chlamydia trachomatis Test, for automated amplification and detection of Chlamydia trachomatis in human samples, were approved for use in Europe.
In 2004, 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), became available for use in Europe. The test is the world's first to develop Affymetrix high-density microarray technology for diagnostic use.
The FDA cleared 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.
In 2005, 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, were approved for use in Europe. The tests are the first to introduce fully automated real-time PCR testing of major viruses to the European market.
Roche PCR Patent expired globally in 2006. Expiry of this patent translated into growth opportunities for Nucleic Acid Purification and Amplification Technologies.
It has enabled many significant advances in the Genome projects, DNA fingerprinting and in the diagnosis and monitoring of diseases such as AIDS and hepatitis. Beyond its wide medical applications, PCR has been used to help in our understanding of evolution, human migration and even for use in food safety, archaeology and forensics.
In 1983, Dr. Kary Mullis at Cetus Corporation conceived 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. For the conception of PCR, the Nobel Prize in Chemistry was awarded to him in 1993.
In 1985, Cetus filed the first PCR patent application. The same year, the first publication of PCR by Cetus Corporation appeared in Science. This is the original publication that first describes the PCR process, amplification of human beta-globin genes and application to clinical diagnosis.
In 1986, purified Taq polymerase was first used in PCR as a replacement to Klenow. The same year saw the first forensic use of DNA typing of HLA-DQA locus using PCR in United States.
Cetus was awarded fundamental patents for PCR in 1987.
In 1988, the automated thermal cycler was introduced by Perkin Elmer. Science printed the first published description of PCR with thermostable polymerase. Also in this year came the first post-conviction review using PCR on a forensic specimen.
In 1989, Taq polymerase was declared "molecule of the year" by Science. The same year, Hoffmann-La Roche Inc. and Cetus began joint development of diagnostic applications for PCR.
The first forensic PCR kit was introduced for HLA-DQA, a polymorphic genetic locus useful for human individual identification in 1990.
The year 1991 saw the development of RT-PCR, which uses a single thermostable polymerase, rTth, facilitating diagnostic tests for RNA viruses; and the first publication on rTth followed by the launch of the first thermostable RT-PCR research kit. Hoffmann-La Roche Inc. acquired worldwide rights and patents to PCR. Roche Molecular Systems, Inc. (informally called Roche Molecular Diagnostics, or RMD) was founded exclusively to develop diagnostic and other tests utilizing PCR technology.
Several such tests were developed (for details refer http://molecular.roche.com/roche_pcr/pcr_timeline.html).
In 1994, Japanese Red Cross and RMS formed a partnership to initiate PCR-based testing for screening donated blood for HIV, HCV and HBV.
In 1995, automated systems for routine diagnostic PCR, standardized "quantitative" PCR kits and AMPLICOR® CT/NG "multiplex" test were launched outside USA.
1996 saw the AMPLICOR® MTB Test for detecting Mycobacterium tuberculosis (MTb) DNA obtain clearance from FDA. The same year, RMS scientists described the first ribonucleotide-incorporating thermostable "designer" DNA Polymerase and "PCR ribo-sequencing." Dynal launched DRB-29 HLA-typing kit for tissue typing.
In 1998, FDA cleared COBAS® AMPLICOR Analyzer for clinical use and approved COBAS® AMPLICOR Chlamydia trachomatis Detection Test.
Dynal launched DQB1-25, HLA B-56 and HLA A-35 HLA-typing kits for use in transplantation tissue typing.
In 1999, U.S. blood centers implemented 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. Japanese Red Cross Society implemented NAT testing to screen 100% of donated blood for HIV, HCV and HBV.
U.S. patent was awarded to RMD inventors for thermostable ribonucleotide incorporating "designer" DNA Polymerase and 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 launched DRB-36 HLA-typing kit for tissue typing.
In 2000, National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) awarded three-year, $1.2 million grant for development of SNP genotyping program using kinetic thermocycler technology to Drs. Gary Peltz, Roche Bioscience (now Roche Palo Alto) and Russell Higuchi of RMD. Dynal launched HLA C-34 typing kit for tissue typing.
In 2001, U.S. patent was 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"). The same year, AmpliTaq GOLD DNA polymerase was launched, featuring the "Hot Start" form of the enzyme and AmpliTaq DNA polymerase FS (the enzyme that sequenced the Human Genome)was introduced. Roche and Chiron Corporation reached 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. The first draft of human genome was published.
In 2002, Roche received 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. Roche Diagnostics acquired broad Human Papillomavirus (HPV) patent portfolio from the Institut Pasteur. Roche and Innogenetics announced the launch of a first series of new microbiology tests, resulting from the co-operation between the two companies.
In 2003, the Human Genome Project was completed. Roche's AMPLICOR® CT/NG Test for Neisseria gonorrhoeae, a microwell plate format test for detection of Neisseria gonorrhoeae in human samples, and Roche's COBAS® AMPLICOR Chlamydia trachomatis Test, for automated amplification and detection of Chlamydia trachomatis in human samples, were approved for use in Europe.
In 2004, 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), became available for use in Europe. The test is the world's first to develop Affymetrix high-density microarray technology for diagnostic use.
The FDA cleared 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.
In 2005, 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, were approved for use in Europe. The tests are the first to introduce fully automated real-time PCR testing of major viruses to the European market.
Roche PCR Patent expired globally in 2006. Expiry of this patent translated into growth opportunities for Nucleic Acid Purification and Amplification Technologies.
No textbook can tell us this...
ReplyDelete2006 was the year I joined the course BE Biotechnology in an engineering college in Bangalore...
ReplyDeleteIt is said that for a student studying a four year under-graduate course, half of what is learnt in the first year is obsolete by the third year.
very true...
ReplyDeletea good account of developments in PCR Technology!!!
a must read for all bt students!!
-
Amazing ! Your have publishing more awesome tips. i read your article.Its very useful.i am also find knowledge about PCR Assay Development Thanks.
ReplyDelete