BARD1 Life Sciences Limited (ASX:BD1) has gained Class II In-Vitro Diagnostic (IVD) medical device registration from South Korea’s Ministry of Food and Drug Safety (MFDS) for the company’s hTERT test, which is used as an adjunct to urine cytology testing.
Mirax Corporation was appointed the company’s exclusive distributor for the hTERT product in the Republic of Korea in December 2018. Mirax is the Korea License Holder (KLH) for hTERT and is required under the terms of the exclusive distribution agreement to place an agreed initial purchase order for hTERT within two days of receiving the MFDS registration.
All medical device manufacturers are required to comply with MFDS Quality Management System (QMS) regulations before their devices can be distributed in Korea. BARD1’s subsidiary, Sienna Cancer Diagnostics, and its contract manufacturer were issued a Korea Good Manufacturing Practice (KGMP) certificate on February 22, 2021.
CEO, Dr Leearne Hinch, said, BARD1 has received the initial purchase order for A$80,000 from Mirax and has notified its contract manufacturer to deliver the product as soon as possible.
Securing Korean registration and our first order from Mirax is the culmination of the BARD1 team’s dedication and effort to expanding the geographical footprint for hTERT in Asia,” Dr Hinch said.
“We are excited to be entering the Korean market and are looking forward to working with the Mirax team to build a strong franchise for hTERT in this key Asian healthcare market.”
The Korean medical device market is ranked as the ninth largest in the world valued at US$6.8 billion in 2018. Urologic cancers, including bladder cancer, are a significant public health problem in the Republic of Korea.
BARD1’s hTERT test can assist pathologists to resolve indeterminate urine cytology to assist in bladder cancer diagnosis and improve patient outcomes.
