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QuantaMatrix, Applied for an Export License from the Korean Ministry of Food and Drug Safety for the COVID-19 Molecular Diagnostic Kit

2020-12-21 10:05:00

QuantaMatrix, Applied for an Export License from the Korean Ministry of Food and Drug Safety for the COVID-19 Molecular Diagnostic Kit

QuantaMatrix (CEO Sunghoon Kwon), which is pursuing a listing on the KOSDAQ, has completed the development of the “QPLEXTM COVID-19 test,” a molecular diagnostic kit for novel coronavirus infection (hereinafter referred to as COVID-19), and applied for an export license to the Korean Ministry of Food and Drug Safety.

This product is a molecular diagnostic kit based on the gene amplification test method. Both the Nasopharyngeal swab test in which a sample is collected and examined by scratching the inner wall of the nasal cavity and the test through a Sputum sample are possible.

QuantaMatrix notified it is planning to apply for an Emergency Use Approval (EUA) from the US FDA within this month for this kit product and to promote European CE certification within this year.

Starting with this COVID-19 molecular diagnosis kit product, QuantaMatrix has a strategy to further expand the COVID-19 diagnosis product line from now on. Firstly, it is planning to release a product that enables accurate diagnosis even through a saliva sample by maximizing test sensitivity by applying a technology that rapidly isolates/concentrates only the infectious agent(virus) from the blood to the molecular diagnostic kit.

Currently, the saliva sample has a limitation in that it is difficult to accurately test because the virus content is less than that of the nasopharyngeal swab sample. On the other hand, the application of the virus separation/concentration technology of QuantaMatrix can dramatically increase the test sensitivity, so that even a small amount of virus can be accurately analyzed, making it possible to test even with samples such as saliva that were difficult to use as a sample.

While the existing nasopharyngeal swab sample collection method had difficulties that had to be accomplished by experts, it is expected that as the saliva can be easily sampled at home even by general inspectors, expanding effective tests and management of diseases such as mass or national inspections to be easy.

Besides, QuantaMatrix is planning to launch a cartridge-type product that is one-stop from isolation/concentration of infection sources to inspection by applying this high-sensitivity test kit product to its full automatic instrument (Sample-to-Answer platform) which is on the developmental stage. By applying the company's multi-diagnosis platform (QMAP) technology, it is also planning to release a multi-diagnosis kit that can simultaneously test for COVID-19 and other similar respiratory viruses.

Meanwhile, QuantaMatrix is currently pursuing IPO for listing on the KOSDAQ, and its representative product is dRAST, a rapid antimicrobial susceptibility test. In addition to sepsis solutions such as △'QID', Quick Whole Blood Bacteria Identification Test △'μCIA(micro CIA)', Rapid Blood Culture·Identification·Antimicrobial Susceptibility Test, it has various pipelines as △'QDST(QuantaMatrix Drug Susceptibility Test)’, Quick anti-tuberculosis drug susceptibility test and △'QPLEX Alz Plus Assay', kit to aid in the diagnosis of Alzheimer's disease.

The total number of public offering shares is 3,220,500 shares, and the range of the proposed public offering price per share is from 21,200 won to 26,500 won. On the 21 and 22, demand forecasting for institutional investors is conducted to determine the final public offering price, and general subscriptions are received on the 25 and 28. Through this public offering, it is expected to raise up to about 85.3 billion won, and the expected listing date is 12 of next month. The listing organizer is MiraeAsset Daewoo.