Panagen Registers Nucleic Acid Extraction Kit with US FDA... 'Shortening COVID-19 Testing Time'

[Asia Economy Reporter Hyungsoo Park] Panagen's nucleic acid extraction devices and kits have completed registration with the U.S. Food and Drug Administration (FDA), raising expectations for synergistic entry alongside existing molecular diagnostic products.

Molecular diagnostics specialist Panagen announced on the 13th that its automated nucleic acid extraction device and three types of nucleic acid extraction kits have completed FDA registration.

Molecular diagnostics confirm the presence of specific nucleotide sequences using molecular diagnostic methods such as realtime polymerase chain reaction (realtime PCR) on extracted nucleic acids. To do this, nucleic acids such as DNA or RNA must first be extracted from specimens collected from test subjects. Providing sufficient quantity and purity of nucleic acids at the extraction stage is essential for successful molecular diagnostics.

Panagen's gene extraction automated device, PANAMAX™ 48, which has completed FDA registration, is a high-throughput device capable of extracting genes from up to 48 specimens at once. It is gaining attention as a versatile device that can handle various specimens simply by changing the gene extraction reagent kits.

It was designed with flexibility to meet different demands depending on the test subject and specimen characteristics. For liquid biopsy, it can process large sample volumes up to 5 mL. For samples requiring high-throughput processing, such as those for COVID-19, it offers a high-speed extraction mode that completes processing within about 20 minutes.

Panagen developed and registered together the following kits: PANAMAX™ Plasma ccfDNA Extraction Kit, a reagent for extracting circulating free DNA used in liquid biopsy, which is attracting attention; PANAMAX™ FFPE DNA Extraction Kit, a reagent for extracting DNA from formalin-fixed paraffin-embedded (FFPE) tissue biopsy specimens, a representative form of tissue biopsy; and PANAMAX™ Viral DNA/RNA Extraction Kit, a reagent for extracting DNA or RNA from swab specimens most commonly used in infectious disease testing including COVID-19.

A Panagen official stated, "The nucleic acid extraction automated device and kits registered with the U.S. FDA are excellent products that have succeeded in capturing multiple goals including nucleic acid extraction efficiency, purity, processing time, and user convenience," adding, "They will contribute to further improving the accuracy of molecular diagnostics."

He continued, "We have already entered overseas markets such as the Middle East and Southeast Asia, focusing on COVID-19 diagnostics, receiving favorable evaluations from domestic university hospitals and public medical institutions," and said, "Once the European CE registration, currently in its final stages, is completed this month, we plan to accelerate market expansion into Europe, Africa, and Russia CIS regions." Panagen currently has an automated reagent manufacturing line capable of mass-producing nucleic acid extraction kits for 1 million tests per month.