Australian firm under TGA investigation says it is making coronavirus tests, despite having no approval or expertise | World news

A tiny Brisbane company linked to coronavirus test scandals in Australia, Puerto Rico and the mainland United States says it is now attempting to fill international orders by manufacturing its own antibody tests, despite having no previous diagnostic experience and the tests being unsanctioned and unproven.

Promedical Equipment Pty Ltd – a company run by convicted rapist Neran de Silva – made a series of promises to deliver huge quantities of Covid-19 tests to governments across the world, initially on the basis that it was able to re-sell equipment from a reputable Chinese manufacturer.

When its deal with the Chinese manufacturer collapsed, Promedical continued to market its own branded test kits, which it falsely claimed had various approvals and said were obtained from an unnamed Australian supplier.

But amid further questioning from Guardian Australia, the company now claims it is the physical manufacturer of its product, raising alarm at a time when experts say the supply of unapproved tests – or the manufacture of tests by unqualified companies – needs greater scrutiny.

The company responded to suggestions it is ill-equipped to manufacture coronavirus tests by comparing its actions to other businesses that have upended their business models to assist with the pandemic response.

“From aeronautical companies manufacturing ventilators and major fashion houses producing face masks, to distilleries producing hand sanitiser, there is an incredibly strong drive to support local communities wherever possible,” a company spokeswoman said.

Only one Australian company, AusDiagnostics, has approval by the Therapeutic Goods Administration to make the sort of Covid-19 antibody tests being marketed by Promedical.

AusDiagnostics is headed by the Cambridge-educated molecular biologist and immunologist Keith Stanley. It has offices in London, Dallas and Auckland.

Promedical is run by de Silva, who was convicted of rape in 2018 and was a one-time business associate of the government services minister, Stuart Robert, through a failed cryotherapy treatment business.

De Silva claims on his LinkedIn page to have medical qualifications from the University of Queensland and Griffith University, but neither has any record of him in their online graduate verification systems.

Before the pandemic, Promedical sold cryogenic treatment, massage therapy and erectile dysfunction machines.

Promedical is under investigation by the Australian Therapeutic Goods Administration in relation to Covid-19 tests. The company’s claims to be able to supply large quantities of tests at the height of the pandemic have been linked to collapsed deals being probed by the US Securities and Exchange Commission and the legislature of Puerto Rico.

The latter deal, to supply 1m tests to Puerto Rico via a US intermediary and a small construction company in San Juan, was cancelled by the government at a critical time for the US external territory, which has desperately low testing rates.

Last week Promedical suffered another setback: a key contractor disowned the company, claiming he was uncomfortable with what he had learned about its practices.

Guardian Australia has obtained an email from Bradley Mayo, who had been handling Promedical’s freight and logistics. He wrote:

“In these unprecedented and extremely challenging times, the medical supply chain industry is volatile at best, with many opportunists who aim to use this time of crisis to … enrich themselves.

“After lengthy investigation and due diligence, I have decided to distance myself from Promedical.”

Guardian Australia revealed last week the Australian government entered a contract in March to buy 500,000 Covid-19 test kits from Promedical, which would import them from Chinese company Guangzhou Wondfo Biotech. Promedical was given approval by the TGA to supply the Wondfo test, but no others.

Last month the company told Guardian Australia that it began receiving its first batch of deliveries of unsanctioned tests, supplied by an Australian company, within days of gaining that approval. Videos apparently showing those tests in a Brisbane warehouse were sent to the importers.

Promedical repeatedly refused to name the test manufacturer, saying only that the supplier was Australian.

But last week the company changed its story, after Guardian Australia learned it was importing chemical reagent, a key component for antibody tests, from South Korea. Promedical now says it is the manufacturer.

“Promedical follows strict guidelines as supplied by the TGA for all products supplied by Australian manufacturers,” a company spokeswoman said. “Promedical works with a number of different suppliers, however its final [test kit] is Australian. The TGA is aware of the suppliers Promedical works with, and details were included in all applications supplied to the governing body.

“Promedical takes responsibility for its [test kit] as the final manufacturer, in line with guidelines and responsibilities set out by the TGA. Promedical works closely with all regulatory bodies in Australia and overseas, including the TGA, to make a positive impact and provide a high-quality product to assist in managing the current health crisis.”

After initially being approached by Guardian Australia in relation to online claims it had approval from the TGA and the US Food and Drug Administration, Promedical removed those references from its websites.

The company says it is now attempting to gain Australian and US approvals for its self-manufactured test.

Last week the FDA allowed Promedical to begin to distribute serology tests in the US, based on the company’s own claims its tests have been validated. The tests have not yet been reviewed or approved by the FDA.

Peter Collignon, an infection diseases expert with the Australian National University, said that while accurate, rapid antibody tests were crucial in the fight against the pandemic, allowing unknown or inaccurate testing on to the market was extremely dangerous.

Australian regulators needed to do more to place suppliers of testing kits under intense scrutiny, he said.

“The trouble is that this is an emergency … we can’t do things on the normal slow bureaucratic process, I fully accept that,” Collignon said.

“But equally we have to have a set of minimum of standards that they accept for both drugs and antibody tests. The post-marketing surveillance has to be more intense than normal because we need to rapidly remove these tests if they’re not up to scratch.”

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