UPDATE : Monday, September 7, 2020
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Philosys’ sample collection kit wins FDA nod
  • By Shim Hyun-tai
  • Published 2020.08.18 18:21
  • Updated 2020.08.18 18:21
  • comments 0

Philosys, an affiliate of Philosys Healthcare, said Tuesday that it has won the approval of the U.S. Food and Drug Administration (FDA) for its Universal Transport Medium (UTM), a coronavirus sample collection kit.

The supply of sample collection kit does not keep up with the demand as Covid-19 is spreading because medical workers should first collect samples by inserting a swab into the nose and immersing it in a special solution before performing the molecular diagnosis method or antigen and antibody test.

Philosys has won the U.S. FDA's approval for its coronavirus sample collection kit, called the Universal Transport Medium (UTM), for the first time in Korea. (Philosys)

The daily demand for diagnosis in the U.S. is about 500,000, requiring the same amount of UTM.

Due to the lack of supply, the National Public Radio of the U.S. mentioned that the most significant thing in responding to Covid-19 is UTM, not the mask, diagnostic kit, or ventilator.

The domestic situation is not much different from the U.S. and Europe, according to Philosys. The government announced a plan to stabilize the supply and demand of UTM on June 8 and presented ways to stock up on two-week reserve of 350,000 units.

Korea uses about 250,000 UTM daily, which is less than that of the U.S., but the testing volume would also surge with the recent spread of Covid-19. The demand for Philosys’ Gmate Universal Transport Medium is expected to continue to increase.

Philosys Healthcare, which holds the copyright of UTM, signed a contract with BBB, a test kit developer, on July 14, and is reportedly coordinating supply contracts with the U.S. military and hospitals.

“While proceeding numerous contracts in the U.S., we were able to speed up the progress with FDA approval,” an official of Philosys Healthcare said. “We are building more production lines in its plant in Gunsan, North Jeolla Province, to expand UTM supply.”

shim531@docdocdoc.co.kr

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