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Seegene Using Molzym DNA-Enrichment Tech for Multiplex PCR Sepsis Test

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Korea's Seegene disclosed today that German molecular diagnostics firm Molzym is providing DNA-enrichment technology for its multiplex PCR-based molecular test for sepsis-causing agents.

Under the agreement, Molzym is providing its MolYsis microbial DNA-enrichment technology, which the company claims enables up to 40,000-fold DNA enrichment over conventional technologies, on the front end of Seegene's Magicplex Sepsis test.

Seegene introduced Magicplex Sepsis in July 2010 (PCR Insider, 7/29/10). The test uses Seegene's proprietary dual-priming oligonucleotide, or DPO, and real-amplicon detection, or READ, PCR technologies; and can identify more than 90 leading sepsis-causing pathogens including 73 gram-positive organisms (30 Staphylococcus, 40 Streptococcus, and three Enterococcus); 12 gram-negative bacteria, six fungi, and three antibiotic-resistant genes (mecA, vanA, and vanB).

According to Seegene, READ PCR differs from probe- and primer-based real-time PCR methods by using a technique called dual signal generation, which specifically amplifies DNA sequences of multiple target pathogens, and reads those signals using conventional real-time PCR instrumentation.

The company claims that READ PCR and DPO together are 400 percent faster and 10- to 100-fold more specific and sensitive for pathogen detection than competing probe- and primer-based real-time PCR technologies.

Magicplex Sepsis requires 1 mL of a patient's whole blood and provides results within three hours, following extraction of DNA, which is performed using Molzym's technology. Automated DNA isolation is performed with Seegene's Seeprep12 instrument, which is based on Nordiag's Arrow system, Seegene said.

The test has not yet received the CE Mark for in vitro diagnostic use in countries recognizing the mark; nor has it received 510(k) clearance in the US. Seegene is, however, currently marketing several of its Magicplaex and Anyplex tests under the CE Mark in Europe and in Asia.

Molzym's MolYsis technology selectively lyses human cells and degrades non-target human DNA, thereby increasing the sensitivity and specificity of PCR analysis of pathogenic genetic material, according to the company.

Combining MolYsis pre-treatment with isolation of enriched pathogen DNA can increase the PCR analytical sensitivity as much as 40,000-fold compared to conventional total DNA isolation, the company said.

In a statement, Molzym CEO said that MolYsis combined with Seegene's Seeprep12 "reduces the total process costs significantly."

Molzym, based in Bremen, offers whole blood pre-treatment kits, MolYsis Basic and MolYsis Basic5, which can be combined with any bacterial DNA isolation kit, including manual and automated systems.

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