MDx Platform Technologies from Bioneer

Molecular diagnostics is an integrated fusion technology of reagents and instruments.

Enzyme-mediated HotStart

Enzyme-mediated HotStart™ Technology (KR 10-292883)

  Molecular diagnostics detection requires maximizing specificity and sensitivity. Such importance is relevant to demonstrate increased sensitivity may result in the difference between life and death for emergency patients, and enhanced specificity may dictate the course of treatment for patient use within a short period of time. To meet this need, Bioneer is able to deliver tools that help physicians make more informed decisions faster and contribute toward the next stage of healthcare as rapidly as possible. HotStart™ technology is a method to detect DNA target from clinical samples with high sensitivity and specificity. This technology utilizes Bioneer’s unique enzyme-mediated HotStart method for PCR amplification. HotStart eliminates non-specific DNA amplification and allows for the most sensitive PCR assays available.

Figure 1
Figure 1. Principle of HotStart™ technology


  - Increase specificity by preventing non-specific zero-cycle product formation
  - Maximize sensitivity by extending the reaction through pyrophosphate cleanup with pyrophosphatase


Figure 2

Figure 2. Serial dilutions of HBV DNA were spiked into human genomic DNA 3ug and amplified by enzyme-mediated HotStart™ method (left panel) and non-HotStart method (right panel). The results suggest that HotStart™ method enables highly sensitive detection of low copies (10 copies) of DNA target by eliminating non-specific PCR amplification.

Intellectual Property

Title Patent No. Application No. Countries
 Hot start PCR Mixture Comprising Pyrophosphate and
10-292883   KR
 Dried Composition for hot-start PCR with Long-Term Stability   10-2007-109055 KR
 Dried Composition for hot-start PCR with Long-Term Stability   20100209973 US