ODX.L Regulatory News (ODX)

OMEGA DIAGNOSTICS GROUP PLC

("Omega" or the "Company" or the "Group")

AbC-19TM rapid antibody test performance evaluation

Peer-reviewed performance evaluation and self-test user experience of AbC 19TM

Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food intolerance, notes

the press release issued today by the UK Rapid Test Consortium ("UK-RTC"), of which Omega is a partner, welcoming the publication of two peer-reviewed studies conducted by Ulster University and involving AbC-19™, a lateral flow test for the detection of neutralising IgG antibodies to the full trimeric spike protein of the SARS-CoV-2 virus.

Highlights from the studies include:

· Excellent laboratory validation performance metrics for the AbC-19™ rapid test for SARS-CoV-2 spike protein IgG antibody detection and semi-quantitative correlation withlaboratory ELISA methods assaying IgG antibodies to the spike protein of the SARS-CoV-2 virus.

· AbC-19™ showed sensitivity of 97.58% and specificity of 99.59% when using evaluation methods as defined by the MHRA for Target Product Profile of an antibody test.

· In addition, the study notes that IgG antibodies to the SARS-CoV-2 virus were detected 10 months after infection. Understanding the longevity of COVID-19 antibodies is importantboth immunologically and in helping to guide pandemic exit protocols.

· Positive user experience score from 1,544 participants who used AbC-19™ as a 'self-test'

Professor Chris Molloy, Independent chairman of the UK Rapid Test Consortium said: "We are entering a phase of the pandemic where testing for immunity will become as or more important than testing for infection. Rapid, accurate immunity tests are therefore a critical tool for citizens and public health providers to embrace. 

"Development of multiple antibody tests, and semi-quantitative approaches will enhance this portfolio and enable the most rapid global recovery."

The UK-RTC press release can be read in full here: 

https://www.abc19.com/peer-reviewed-performance-evaluation-and-self-test-user-experience-of-abc-19/

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