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Australia’s medicines regulator has outlined tough advertising rules for suppliers of rapid antigen COVID-19 tests, including requirements to highlight that a negative test result does not guarantee a person is free of the coronavirus.
The Therapeutic Goods Administration (TGA) has also warned biotechnology companies that they must also make it clear when advertising rapid antigen products that they cannot be used at home, while any individual who tests positive must be referred immediately for a PCR test to confirm their infection.
Australia has been slower than other nations to implement rapid antigen tests, though this is changing in the face of the Delta variant. Credit:Kate Geraghty
“While COVID-19 rapid antigen tests are an important supplementary screening tool for use in efforts to curb the spread of COVID-19, they are not equivalent to PCR testing which is the gold standard test used in managing outbreak,” the regulator said in guidance to suppliers.
“The following statement must be included in the advertisement: ‘negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained).’”
The advertising rules apply to any communications about the tests that may be consumed by the public, like information about products contained on a company’s website.
Companies have more freedom when advertising directly to healthcare providers, but they must ensure these materials are only available to health professionals.
Australia has been a late adopter of rapid tests for coronavirus compared to other nations. However, point-of-care products which deliver a result in minutes have boomed in recent weeks as New South Wales amps up testing in a bid to control the spread of the Delta variant.
The TGA’s advertising rules build on strict supply rules for the rapid tests which specify that they should only be used and analysed by medical professionals, rather than members of the public.
Suppliers of the tests are also banned from making claims that their tests can detect coronavirus earlier than other products, or infer that a product can determine whether a person is infectious.
Rapid test companies are also bound by the Therapeutic Goods advertising code, which states ads for medical products “must not be likely to lead people to delay necessary medical attention”.
Test manufacturers warned last week that businesses were now scrambling to access stock after new rules came into play for testing authorised workers in New South Wales last week.
The renewed focus on rapid testing has boosted ASX-listed diagnostics businesses. Atomo Diagnostics, which has a rapid antigen test registered with the TGA, is up 17.5 per cent over the past month to 24c.
Recently-listed Lumos Diagnostics is up 4.1 per cent.
Businesses that offer rapid antigen tests to employees and visitors are allowed to share this information, but must follow the advertising rules if they mention a particular brand or type of test.
Rapid antigen tests are already used widely in the United Kingdom, while an over-the-counter test developed by Brisbane startup Ellume is available in the United States.
In a question and answer briefing released this month, the TGA explained why home testing is not currently allowed in Australia.
“The supply of home tests for COVID-19 is currently illegal as COVID-19 is a serious disease and testing should be performed by a suitably qualified health practitioner who is able to provide immediate clinical advice and treatment if required,” the regulator said.
“There is also a potential risk that some individuals could be motivated to conceal or not report a positive test, especially if they felt that their symptoms were mild and, for example they might lose employment income, be unable to go on holiday, or miss an important family event.”
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