- COVID-19 cases are increasing, on an average of 100,000 per day, with more than 6.4 million confirmed cases reported to WHO.
- Growing need for developing diagnostic test is expected to boost the global diagnostic market growth.
- Atomo has obtained exclusive rights for marketing antibody test kits for COVID-19 across Australia, South East Asia and New Zealand.
- COVID-19 Antibody Test developed by Atomo demonstrated 100% specificity in a study conducted in France.
World Health Organization (WHO) data has highlighted 6,416,828 confirmed cases of COVID-19, with 382,867 fatalities across the globe, as of 4:17 PM CEST.
As the number of COVID-19 cases is increasing across the world, there is surging demand for developing diagnostic tests, which is anticipated to boost the global diagnostic market growth. Early diagnosis of the coronavirus infection remains a priority at this time to slow the spread of COVID-19, as cases are increasing on a daily basis.
A number of clinical trials are underway for the development of vaccine or treatment to combat COVID-19, but detection of disease is more important so that the spread can be contained.
With this backdrop, let us get acquainted with one newly ASX-listed healthcare company, Atomo Diagnostics, making significant contribution amid the COVID-19 outbreak with its COVID-19 antibody test.
About Atomo Diagnostics
Australian company, Atomo Diagnostics Limited (ASX:AT1) is a leading global provider of medical devices for blood-based rapid test, designed for professional use and self-test applications. Its innovative rapid diagnostic test (RDT) platforms are user friendly, simplifying procedures, improving test performance and mitigating common user errors.
The Company has supply agreements for test solutions that target infectious diseases such as COVID-19, HIV and bacterial versus viral differentiation. AT1 has developed rapid diagnostic test for COVID-19 and is collaborating with several prominent biotechnology and diagnostic players to overcome the challenges posed by the coronavirus pandemic.
COVID-19 Rapid Diagnostic Test Partnership
As part of its support during the COVID-19 pandemic, Atomo Diagnostics teamed up with NG Biotech, SAS, a French in vitro diagnostic specialist, in March 2020. The resultant rapid test- NG-TEST® IgG-IgM COVID-19 All-in-One applies the integrated AtomoRapid™ Galileo RDT platform for superior safety and utility. AtomoRapid™ Galileo has received the CE Mark approval for its professional use across Europe.
Each single-use, disposable test needs just one drop of capillary blood taken from the fingertip and offers an easy-to-interpret end result within 15 minutes. This test kit by Atomo is distributed in Europe by NG Biotech.
Exclusive Rights for COVID-19 Antibody Test in ANZ and South East Asia
Stepping up its fight against COVID-19, Atomo Diagnostics has secured exclusive rights for the COVID-19 antibody test in many countries, with the expansion of its existing COVID-19 rapid test partnership with NG Biotech, announced in its Second Supplementary Prospectus.
Under Atomo’s existing binding supply agreement with NG Biotech referenced in the prospectus, the Company has been supplying NG Biotech with its Galileo rapid test device for use in NG Biotech’s blood-based rapid antibody IgG/IgM COVID19 test, which is branded ‘NG Test IgG / IgM COVID19’ when sold by NG Biotech in Europe.
It is notable that so far, NG Biotech has placed an order of more than 1.5 million Galileo devices from Atomo for use in its COVID-19 antibody test in France.
Under the Atomo-NG Biotech partnership expansion, now Atomo as the listed manufacturer has exclusive rights for marketing as well as distribution of the COVID-19 antibody test across Australia and New Zealand, under the brand ‘AtomoRapidTM COVID-19 (IgG/IgM)’. This expansion also covers several countries in South East Asia, including Singapore, Malaysia, Indonesia, Taiwan, Hong Kong, Thailand, Vietnam, Myanmar and the Philippines, which are subject to securing the required regulatory approvals in each jurisdiction.
Currently, the exclusivity period has not been specified, and both the companies are continuing to negotiate a definitive long-term supply agreement. The pricing agreements with NG Biotech are constrained to a price that is payable on the basis of per unit only and without any licence costs or royalties.
On the basis of an assessment of regulatory pathways, initial focus of Atomo will be Australia, Hong Kong, Taiwan and the Philippines.
Atomo’s COVID-19 Antibody Test Showed 100% Specificity
In a study conducted in France by Hospital Bicêtre, Bacteriologie Hygiene tested 256 sera from 101 patients hospitalised with COVID-19, during mid-March 2020 for IgM and IgG by using the NG Test IgG / IgM COVID-19.
The results from the study reported that the specificity, sensitivity, and positive and negative predictive value were 100%, 97.0%, 100% and 96.2%, respectively, fifteen days after the onset of symptoms.
Stock Information - On 5 June 2020, AT1 stock inched upward by 4.762% to close the day’s trade at AUD 0.33, with a market capitalisation of nearly AUD 176.74 million and 561.08 million shares outstanding on ASX.
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