BARD1 Life Sciences Ltd (ASX: BD1) shares are climbing today following a favourable outcome for the company's hTERT test. At the time of writing, the BARD1 share price has leapt 6.34% to $3.86.
Let's take a closer look at what the diagnostics company announced.
What's pushing the BARD1 share price higher?
Investors have been driving up the BARD1 share price after the company provided a positive announcement before market open.
According to its release, BARD1's hTERT test has been granted Class II In-Vitro Diagnostic (IVD) medical device registration from South Korea's Ministry of Food and Drug Safety (MFDS).
The pleasing result will now see the company's hTERT product distributed across South Korea through Mirax Corporation (Mirax). Previously in late 2018, BARD1 entered an exclusive distribution agreement with Mirax for the hTERT test.
Under the initial terms of the deal, BARD1 received a purchase order from Mirax within two days of receiving IVD registration. The first lot of hTERT products is expected to generate revenue of $80,000 for BARD1.
Addressable market opportunity
The South Korean medical device market is considered to be a massive opportunity for BARD1. In 2018, the country's medical device market was ranked as the ninth-largest in the world and valued at more than US$6.8 billion.
Urological cancer, including bladder cancer, is seen as an increasingly significant health problem in South Korea. A 2011 published report stated that urological cancer accounted for 8% of all known cancers in the country.
What did management say?
BARD1 CEO Dr Leearne Hinch hailed the company's progress, saying:
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. 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.
Mirax CEO Sang-Ju Bae continued on to add:
Mirax believes there is a significant opportunity for hTERT to become a key product in the bladder cancer diagnostic market in Korea. We are confident that the Mirax / BARD1 partnership can position hTERT as a valuable tool for cytologists, pathologists and urologists in the fight against bladder cancer.
Foolish takeaway
The BARD1 share price changed little over the course of 2020, however, in 2021, it has gained more than 460% year to date.