Medtech company Atomo Diagnostics (ASX: AT1) has been granted regulatory approval in Australia for their patented AtomoRapid HIV (1&2) rapid diagnostic kit which will enable testing for HIV with just one drop of blood.
The approval granted by the Therapeutic Goods Association (TAG) enables Atomo to commence distribution of the diagnostic test to medical professionals around the country which will help prevent transmission of HIV.
“We are very pleased to have received TGA approval for our AtomoRapid HIV (1&2) professional use diagnostic test,” said Atomo Managing Director, John Kelly.
“We already manufacture and supply the only HIV self-test to have been approved for sale in Australia, so we see this latest approval as further confirmation of our expertise in this field.
“This latest good news follows our recent TGA approvals for rapid antigen and antibody tests that detect SARSCOV-2, the virus that causes COVID-19, and means we can now further expand our portfolio of best-in-class rapid diagnostic tests in our home market.”
Although there is no cure for the Human Immunodeficiency Virus (HIV), early diagnosis of the virus can enable sooner use of antiviral drugs which can effectively control the virus, while preventing the patient from unknowingly spreading the incurable disease.
The device in particular is highly unique in its size, instantaneous diagnostic test strip, and delivery mechanism to identify the presence of antibodies that are created by an individual carrying the virus.
Subsequently, the device has been developed further to test for COVID-19 while its design enables further commercial opportunities in the medical field across a range of viruses.
Regulatory approval for Atomo’s AtomoRapid COVID-19 rapid antibody test was granted in August while 2 million units of the test have already been pre-purchased for use in the United States.
Atomo is currently in the process of scaling up their manufacturing capacity where they have completed the first phase of their expansion which will increase monthly production capacity from 300,000 units to 750,000 units.
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