Medical Gyeonggi e-News

[Vitro] Leader in the field of Semiconductor-based In Vitro Solutions

  • Name 관리자
  • Date 2022-05-02
  • Views 1066

Leader in the field of Semiconductor-based In Vitro Solutions



▲ CEO of OPTOLANE, DoYoung Lee


Please introduce Optolane to us.

「Opening a new chapter of semiconductor technology to in vitro diagnostics (IVD)」

Founded in 2012, Optolane develops and sells in vitro diagnostics solutions. Our company was the first in the world to use semiconductor-based biosensors for diagnostic systems. We have a complete range of diagnostic solution products, starting from diagnostic kits to diagnostic systems, and were selected as an innovative medical device company(same as “Breakthrough Devices Program” by FDA) last December by the Ministry of Health and Welfare. Last year, we released a real-time PCR and cartridge that can test for COVID-19 in just one hour. Recently, we also released real-time PCR kits that can reduce the turnaround time for results to 30 minutes at approximately half the price. For these kits, we have also applied for a medical device manufacturing license to the Ministry of Food and Drug Safety. We are aiming to be listed on KOSDAQ in the second half of this year, and expand our range of products to diagnostics to detect cancers such as blood cancer, leukemia and breast cancer.


Briefly tell us about the strengths of the in vitro solution.

「A complete range of products, from diagnostic kits to diagnostic solutions」

Our Kaira COVID-19 Variants Detection Kit, which is a diagnostic kit that uses reagents for real-time polymerase chain reaction (PCR) virus detection, and Geneplexor SARS-CoV-2 Variants Kit, a diagnostic kit in the form of a semiconductor cartridge, can detect all identified variants of COVID-19, including Omicron, Alpha, Beta, Gamma, Delta, and Delta Plus. Our Kaira COVID-19 Variants Detection Kit can show not only, whether or not, the sample is infected by the COVID-19 virus but also identify the type of variant with a single test. The Geneplexor SARS-CoV-2 Variants Kit, Korea’s first digital PCR device, uses a semiconductor to provide COVID test results just after one hour without having to extract RNA. We also export the device as it was certified for export by the Ministry of Food and Drug Safety, and also received a CE certification (CE-IVD) to be sold in Europe as in vitro diagnostic devices.




Recently, both of our Geneplexor COVID-19 Detection Kit, which is a real-time PCR diagnostic kit that takes only 30 minutes from obtaining samples to getting results, and the LOAA(Lab On An Array)-M system, a PCR diagnostic device that allows multiple tests at once, were CE-IVD certified. The diagnostic kit is a cartridge with a semiconductor as small as a fingernail that can extract nucleic acid and amplify the gene, reducing the manual work of the medical team. The kit is also called “Sample-to-Answer” as it takes in samples and provides results. The diagnostic device uses the random access method that allows 16 simultaneous tests. Samples can be loaded continuously in the PCR diagnostic device when they are received from patients. One of its strengths when used for COVID tests in emergency rooms or small-scale hospitals is that it yields results just after 30 minutes, rather than taking one day. Quick point-of-care testing (POCT) can now be provided on site.


What are your future business plans or blueprint after entering the foreign market?

「Head-on fight with global leaders」

Our COVID-19 Detection Kit received Emergency Use Authorization (EUA) from the FDA in the United States, and was CE-IVD certified in Europe, which allowed us to export our products in various foreign markets including the Southeast Asian market such as Indonesia and the Philippines, and the Latin American market such as Mexico and Brazil. Our sales have increased by almost five times last year to approximately KRW 25 billion. This year, we expect tangible results from our LOAA-M System as well. Based on these successful results, we will launch our products to various parts of the world, including not only Europe but also the United States, Indonesia, Brazil and more starting from the second half of this year. Optolane's goal is to grow into an international brand in the IVD field by engaging in competition with various global leaders in this field.