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Prices & Quotes - UK Markets - Omega Diagnostics Group (ODX)

Risk Warning The value of investments can fall as well as rise and any income from them is not guaranteed and you may get back less than you invested. Past performance is not a guide to future performance.

Share Price:
Up 32.50p
Change Today:
9.75p
Market Cap:
59.37m
Sector:
Health Care Equipment & Services

Omega Diagnostics progresses Covid-19 test with EU, US regulators

By Josh White

Date: Tuesday 08 Jun 2021

LONDON (ShareCast) - (Sharecast News) - Medical diagnostics company Omega updated the market on regulatory approvals for the 'Visitect' Covid-19 antigen test on Tuesday, confirming that it has started engaging with its European notified body, seeking CE-marking of the test.
The AIM-traded firm described Visitect as a "rapid, point-of-care" diagnostic test for the detection of active Covid-19 infections, used as a self-test.

It said it was currently agreeing the protocols required for utilisation studies, and would issue updates as that process progressed.

The test was already CE-marked for professional use, with Omega targeting approval by the end of July to allow the test to be sold in Europe for home use as well.

As the global market for antigen testing developed, the company said it believed self-test approval would be a "key product differentiator", as had already been seen in the UK.

Omega also announced that its technology partner Mologic had successfully completed the necessary performance studies required for regulatory approval in the United States, and was now in the final stages of preparing a submission to the US Food and Drug Administration (FDA) requesting emergency use authorisation (EUA) for its rapid point-of-care Covid-19 antigen test, under both the Omega's Visitect brand and the 'Global Access Diagnostics' brand.

"I am pleased with the progress we are making to gain regulatory approval, both for our VISITECT self-test product and for US professional use," said chief executive officer Colin King.

"Both routes offer potentially significant opportunities as we believe we have a high quality product with global appeal."

At 0909 BST, shares in Omega Diagnostics were down 0.41% at 60.25p.

Note 1: Prices and trades are provided by Digital Look Corporate Solutions and are delayed by at least 15 minutes.

 

ODX Market Data

Currency UK Pounds
Price 32.50p
Change Today 9.75p
52 Week High 99.50p
52 Week Low 21.25p
Volume 28,457,661
Shares Issued 182.68m
Market Cap 59.37m
Beta 1.60

Performance Indicators

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ODX Dividends

No dividends found

Trades for 01-Dec-2021

Time Volume / Share Price
14:48 18,227 @ 31.66p
14:48 3,500 @ 32.09p
14:48 25,000 @ 31.66p
14:48 132,983 @ 32.14p
14:48 3,092 @ 32.14p

ODX Key Personnel

CEO Colin King
Chair Simon Gordon Douglas
CFO Christopher Paul Lea