Omega Diagnostics Gp (ODX.L) Approval for sale in India

Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food intolerance testing, announces that its CE-Marked Mologic ELISA1 antibody test has been approved for testing of COVID-19 in India.

Yesterday the Central Drugs Standard Control Organization, part of the Ministry of Health & Family Welfare, published a list of approved Rapid / CLIA / ELISA kits approved for testing of COVID-19, which included Omega’s ELISA antibody test.

Approval for sale remains conditional on the submission of supporting technical data and the Company is confident that this submission will be successful, and that Omega will be able to sell its ELISA antibody test directly into this potentially significant target market. The laboratory-based ELISA antibody test has high quality performance data and has been independently validated by the Liverpool School of Tropical Medicine and St George’s, University of London.

Whilst the quantum of future sales in unknown at this stage, India is clearly a significant addressable market for COVID-19 antibody testing and Omega will use its direct sales team in India to establish commercial roll-out in the region. The Company expects to update shareholders on first commercial orders as they are received.

Colin King, CEO of Omega commented: “I am delighted that we have received approval to sell the Mologic ELISA antibody test in India as this is a key target market. We have an established direct sales team and we believe a reliable and high-performance antibody test will be very attractive to our laboratory customers. 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.”

1 ELISA (Enzyme Linked Immuno-Sorbent Assay) tests are one of the most tested and proven laboratory technologies used by the global diagnostic industry and remain the principle reference point from which rapid diagnostics are coordinated, especially serological tests, including tests for COVID-19.

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