Optolane Acquires European CE-IVD Certification for 30-Minute Ultra-Fast PCR Diagnostic Device
January, 2022
GENOLOAM is proud to announce that our partner company, Optolane, specializing in semiconductor-based diagnostic products, announced on the 25th of January that they have obtained European certification (CE-IVD) for two products: a gene amplification diagnostic (Real-Time PCR) product that produces the result from sample collection within 30 minutes and a PCR diagnostic device that can perform simultaneous testing. The products certified in January included cartridge-type 'Genoplexor™COVID-19 Detection Kit' and 'LOAA-M System' PCR diagnostic device.
Genoplexor™ COVID-19 Detection Kit performs both nucleic acid extraction and gene amplification inside a small chip the size of a fingernail. The total inspection time of about 30 minutes is the fastest in the world and there is no comparison in its speed and accuracy in comparison to other globally known products. The product is called Sample-to-Answer due to its ability to significantly minimize manual work by medical staff and allows them to know sample input and results immediately. The LOAA-M System is a random access PCR diagnostic device that can test 16 samples simultaneously. In the case of general real-time PCR, which is currently widely used, the test starts after collecting several samples. Therefore, only after the previous PCR test is completed, the next test is carried out, so it is necessary to wait for several hours. However, the LOAA-M System can put samples into the PCR diagnostic device continuously and perform tests as soon as the patient arrives.
Optolane has applied for an item manufacturing license to the Ministry of Food and Drug Safety in Korea for the Genoplexor™ COVID-19 Detection Kit. Once the permit is received, Optolane is planning to supply the Kit as a point-of-care (POCT) product to places where people need rapid PCR test, such as urgent overseas travelers, emergency room patients, and those who have not been vaccinated and need a quarantine pass.