Australian biotech Genetic Signatures’ (ASX:GSS) is now able to start selling its recently developed COVID-19 diagnostic kit, after it was approved for sale in Australia.

The EasyScreen SARS-CoV-2 Detection Kit has been approved to be listed on the Australian Register of Therapeutic Goods (ARTG).

The company’s test is a lab-based test which Genetic Signatures CEO Dr John Melki told Stockhead last week the company was initially pitching to pathology and microbiology labs. Genetic Signatures has already had sales talks with major listed companies.

But there is also strong interest from industry, particularly the mining and food sectors.

The company received European approvals in early April.

“This registration comes at an important time with the onset of the domestic flu season approaching,” Melki said.

Several domestic private and public testing laboratories are already using the tests, as the Therapeutic Goods Administration has allowed registered labs to use unregistered COVID-19 diagnostics kits in order to deal with the massive shortage in tests.

Thirty companies have had COVID-19 diagnostic kits approved for registration on the ARTG, and the total number of kits now on the register numbers 21 (some companies have sponsored the same kit).

There are two types of kit: the lab-based antigen test is best used for frontline diagnostics, where medical professionals need to know if a person has COVID-19. This is Genetic Signatures’ test.

The antibody test can be used at the point of care, so in a doctor’s clinic for example, to find out whether people have had the disease. It can’t tell if a person is currently infectious.

Testing is essential if Australia wants to reopen its economy, as a publicly available vaccine is, at the earliest, two years away.


In other ASX health news:

Healthcare company Healius (ASX:HLS) says COVID-19 tests and GP telehealth consultations are partially offsetting drops in other business segments, while cost cutting including deferral of the interim dividend has helped conserve cash. It’s also actively looking to buy more medical clinics.

Respiri (ASX:RSH), meanwhile, has signed a joint venture with Australian telemedicine company Phenix Health, to integrate its wheezo eHealth SaaS monitor into the latter’s platform.