Unmet Need
The COVID-19 pandemic underscored the importance of rapid and sensitive testing for infectious material to limit the spread of a virus. The gold standard of testing is detection of viral DNA by polymerase chain reaction (PCR). PCR has long been used in laboratory settings and can reliably detect viral infection at a highly sensitive level (CDC 2022). While sensitive and reliable, PCR testing is limited because the large demand for this assay causes results to be delayed. Additionally, these tests can only be performed in a lab setting that has a thermocycler, further limiting the access to fast results. Current PCR tests for COVID-19 testing are either provided at a medical facility or require patients to ship samples to a lab where testing can be performed. This limits access to tests and has delays in notifying patients of their status. To better cater to the demands of reliable PCR testing, there is a need to streamline sample testing to rapidly return results.
Technology Overview
Researchers at Johns Hopkins have discovered a method of improving the current state of polymerase chain reactions (PCR). Current methods of PCR require thermocyclers that continually change temperatures which limits the ability of non-lab environments to run medical tests that involve PCR. Researchers at Hopkins have discovered a way of carrying out a PCR reaction at a constant temperature using SSB-Helicase Assisted Rapid PCR (SHARP). This technology can be used for testing of viral infections such as SARS-CoV2 at medical locations without access to thermocyclers with a potential expansion to at home testing in the future.
Stage of Development
Isothermal SHARP technology has been developed.
Publication
Gavrilov M, Yang JYC, Zou RS, Ma W, Lee CY, Mohapatra S, Kang J, Liao TW, Myong S, Ha T. Engineered helicase replaces thermocycler in DNA amplification while retaining desired PCR characteristics. Nat Commun. 2022 Oct 23;13(1):6312.