A Frost and Sullivan report out says that the expiration of the Polymerase Chain Reaction (PCR) patent (US Patent No. 4,683,202) is setting the stage for growth opportunities for nucleic acid purification and amplification technologies. Companies can now offer tests without developing a novel nucleic acid technology or paying a license fee.

The expiration of the PCR patent will be especially beneficial to academic research, given that they lack money but have lots of indentured grad students who can put together their own kits. The report also takes into account funding resources becoming ever scarcer causing researchers to look for alternatives for inexpensive sample preparation.

There is an intrinsic paradigm shift in research as the scientific community transitions from sequencing to functional genomics. This will lead to a greater need for consistently pure nucleic acid samples, which will drive demand for automated instrumentation products.

The demand for nucleic acid-based amplification kits is expected to continue over the next decade due to the completion of the human genome project and growing interest in molecular diagnostics.

The polymerase chain reaction is a test tube system for DNA replication that allows a “target” DNA sequence to be selectively amplified, or enriched, several million-fold in just a few hours. PCR uses just one indispensable enzyme – DNA polymerase – to amplify a specific fraction of the genome. DNA polymerase was first isolated from Thermus aquaticus in 1976. (Deoxyribonucleic acid polymerase from the extreme thermophile Thermus aquaticus by A Chien, D B Edgar, and J M Trela in Journal of Bacteriology 127 (3): 1550–1557.)

To perform a PCR reaction, a small quantity of the target DNA is added to a test tube with a buffered solution containing DNA polymerase, oligonucleotide primers, the four deoxynucleotide building blocks of DNA, and the cofactor MgCl2. As amplification proceeds, the DNA sequence between the primers doubles after each cycle. Following thirty such cycles, a theoretical amplification factor of one billion is attained.

The polymerase chain reaction was introduced at a conference in October 1985. Cetus rewarded the inventor, Kary Mullis, with a $10,000 bonus for his invention and later sold the patent for the PCR process to the pharmaceutical company Hoffmann-La Roche for $300 million.

More information on the report is available here.

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