Omega Diagnostics (AIM:ODX) told investors this morning that its CE-Marked Mologic ELISA1 antibody test has been approved for testing of coronavirus - Covid-19 - in India.
The Central Drugs Standard Control Organization, which is part of the Ministry of Health & Family Welfare, published a list on Wednesday of approved Rapid / CLIA / ELISA kits approved for testing of COVID-19, which included Omega's ELISA antibody test.
Final approval in India still remains conditional on the submission of supporting technical data and the company has maintained that it is confident the submission will be successful.
Omega’s test is said to have ‘high quality performance data’ and has been independently validated by the Liverpool School of Tropical Medicine and St George's, University of London.
Upon final approval, Omega will be able to sell its laboratory-based ELISA antibody test directly into India, a significant addressable market for COVID-19 testing at this stage.
Shares in Omega Diagnostics were trading 5.65% higher at 43p on Thursday morning.
Omega will use its direct sales team in India to establish commercial roll-out in the region.
While Indian authorities have battled to contain the pandemic while easing lockdown rules, the number of Covid-19 infections today has surpassed 600,000, with 17,834 total deaths.
“The increase in infections presents a severe challenge for India’s strained medical capacity and overburdened health system," said Himanta Biswa Sarma, Health Minister of the Northeast Indian state of Assam which has recently witnessed a surge in cases.
"I am delighted that we have received approval to sell the Mologic ELISA antibody test in India as this is a key target market,” said Colin King, CEO of Omega.
He added, “India is one of the fastest growing economies in the world and has a population of over 1.3 billion people. Clearly this is an important market for us to target and I look forward to updating shareholders on our commercial traction."
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