MDx Kit

AccuPower^® Technology

Figure 1. AccuPower^®Premix Tube

Convenience in Performance

AccuPower^® Real-Time PCR Diagnostic Kits are vacuum-dried qPCR and RT-qPCR premixes. All the components necessary for real-time PCR are contained within one tube, which increases the stability of reagents, and allows simplified reaction setup. Because of this simplified setup, AccuPower^® technology is ideal for automated molecular diagnostics.

Features

Signature Convenience
  - All components for the assay are contained within a tube.

Outstanding Reproducibility
  - Large-scale batch production through automated processes guarantees repeatability of results.
  - Premixed PCR reagents minimize human error and enhance precision.

Industry-Leading Stability
  - Vacuum-dried premix suspends reagent deterioration, which allowing a shelf life of 1 year.

Performance

Stability Test

Figure 2. Stability test was performed to evaluate the stability of the AccuPower^® CMV Quantitative PCR Kit. From the results, the validity period of the AccuPower^® CMV Quantitative PCR Kit was determined as 12 months at -20°C (-22~-18°C).

Intellectual Property

Title	Patent No.	Application No.	Countries
Method for DNA polymerase reaction mixture production	10-162270		KR
Lyophilizes reagent for polymerase chain reaction	5861251		US
Lyophilizes reagent for polymerase chain reaction	6153412		US

Enzyme-mediated HotStart™ Technology

Enzyme-mediated HotStart™ Technology

Figure 1. Principle of HotStart™ technology

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.

Features

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

Performance

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 Pyrophosphatase	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

Dual-HotStart™ Technology

Dual-HotStart™ Technology

Figure 1. Principle of Dual-HotStart™ technology

Dual-HotStart™ technology is a method to detect RNA target from clinical samples with high sensitivity and specificity. This technology utilizes Bioneer’s unique enzyme-mediated HotStart™ method for both reverse transcription and PCR amplification. Dual-HotStart eliminates non-specific cDNA synthesis and non-specific DNA amplification and allows for the most sensitive one-step RT-qPCR assays available.

Performance

Dual-HotStart™ RT-PCR technology enhances specificity and sensitivity by removing non-specific RNA amplification.

Figure 2.High-sensitivity detection of RNA target

Serial dilutions of HCV RNA were amplified by conventional RT-PCR (left panel) or Dual-HotStart™ RT-PCR (right panel). The results suggest that Dual-HotStart™ RT-PCR enables highly sensitive detection of low copies of RNA target by eliminating non-specific cDNA synthesis and non-specific PCR amplification.

Intellectual Property

Title	Patent No.	Application No.	Countries
Compositions for hot start reverse transcription reaction or hot start reverse transcription polymerase chain reaction		KR 10-2013-0025119	KR
Compositions for hot start reverse transcription reaction or hot start reverse transcription polymerase chain reaction		PCT/KR2013/001935	PCT

RoketScript™ Reverse Transcriptase

RocketScript™ Reverse Transcriptase

Figure 1. Structure of RocketScript™ reverse transcriptase

Protein engineering

We analyzed the structure and thermodynamics of native M-MLV and applied numerous point mutations to increase the thermostability without compromising reverse transcription performance. Afterwards, we synthesized each individual gene and expressed the numerous variants to screen them on thermostability and performance. We selected the best candidate and named it Structure of RocketScript™ for its unparalleled performance.

The Problem

Complex secondary structures in RNA molecules prevent efficient cDNA synthesis

The Solution

Melt the stems and loops so the reverse transcriptase can do its job

Features

Increase sensitivity for RNA targets
Maximize specificity with full-length cDNA products

RocketScript™ is Bioneer’s exclusive M-MLV based thermostable reverse transcriptase (RTase). Native M-MLV RTase has maximum activity at relatively low temperatures (42 °C), causing several problems in reverse transcription of complex secondary structure RNA molecules. RocketScript™ has thermostable activity (42~70 °C), allowing efficient cDNA synthesis from complex secondary structure RNA. Melt the stems and loops keeping you away from your results.

Performance

Figure 2.Compared to a leading reverse transcription product (B), RocketScript™ (A) shows excellent stability at all tested temperatures. (Target gene: Human Myc (495 bp)). Lanes 1-4 are 100, 10, 1 and 0.1 ng human total RNA extracted from HeLa cells, respectively.

Intellectual Property

Title	Patent No.	Application No.	Countries
Cyclic reverse transcription method	10-984483		KR
Cyclic reverse transcription method		20100221786	US
Reverse transcriptase having improved thermostability		10-2011-0011639	KR

MDx Kit

AccuPower® Technology

Features

Performance

Intellectual Property

Enzyme-mediated HotStart™ Technology

Features

Performance

Intellectual Property

Dual-HotStart™ Technology

Performance

Intellectual Property

RocketScript™ Reverse Transcriptase

The Problem

The Solution

Features

Performance

Intellectual Property

AccuPower^® Technology