Molecular Viability Test for High Precision PCR

What is the Problem?

The polymerase chain reaction (PCR) is an integral tool in research, clinical, and environmental microbiology. Although the method has become significantly more reliable and user-friendly in recent years, its sensitivity remains problematic when targeted to nucleic acids that are present in very small numbers. For example, background signal levels can be substantial due to the presence of dead cells, and positive results can be muted by inhibitory substances in complex biological and environmental samples.

What is the Solution?

The innovation offers a method called molecular viability testing (MVT), which improves the specificity of PCR for viable microbial cells by 5-fold to >10-fold and decreases background signal from non-viable cells. MVT measures a change in bacterial physiology, specifically the increased pre-rRNA copy number in response to nutritional stimulation, as opposed to qPCR, which measures the static copy number of target DNA molecules. This method significantly enhances the resolving power, analytical sensitivity, and specificity of PCR detection for diverse bacterial pathogens in human and environmental sample types.

What is the Competitive Advantage?

The competitive advantage of MVT lies in its improved sensitivity and specificity compared to traditional PCR methods. As the microbiology testing market is expected to register a CAGR of 9.4% during the forecast period 2022-2027, MVT has the potential to contribute to this growth by offering a more reliable method for various applications, including diagnosis of sterile-site infections, smear-negative tuberculosis, high sensitivity biodefense testing, and eliminating false signals in elevated temperature processes like pasteurization. This technology can enhance the accuracy and reliability of PCR-based testing in clinical, research, and public health markets.

Patent Information:

US9115407B2