Coronavirus: Bill Gates-backed Hong Kong start-up wins US FDA approval for their Covid-19 rapid test kit, even in mid-US-China strain
Coronavirus: Bill Gates-backed Hong Kong start-up wins US FDA approval for their Covid-19 rapid test kit, even in mid-US-China strain

Coronavirus: Bill Gates-backed Hong Kong start-up wins US FDA approval for their Covid-19 rapid test kit, even in mid-US-China strain

Phase Scientific International (PSI), the start-up in Hong Kong that demarcated established Chinese peers from the mainland to win US approval for a Covid-19 rapid antigen test (RAT) kit, owes its success to its US roots and experience in the field, according to its founder.

The Bill and Melinda Gates Foundation-backed biotech company in July last year became the first in mainland China, Hong Kong, Macau and the Taiwan region to win approval from the U.S. Food and Drug Administration for emergency use of their Covid-19 kit.

Ricky Chiu Yin-to, a Hong Konger who moved to the United States to take a Ph.D. in bioengineering at the University of California, Los Angeles, founded the company in 2015. He moved his headquarters from California to Hong Kong in 2018.

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“This move, a bet at the time, has paid off in full,” said Chiu, who is also CEO South China Morning Post. “The technology I was working on was good, but was mature and very competitive in the US … hence the idea of ​​returning to Hong Kong and taking advantage of opportunities in China.”

PSI initially focused on commercializing a patented method that improves the accuracy of fluid diagnostic tests by concentrating and purifying target molecules in blood or saliva. It started by launching a caries risk detection kit of $ 10 in late 2018.

Its priorities changed as soon as the Covid-19 virus began to spread outside mainland China in early 2020.

“Our first thought at the time was to develop a rapid test kit for the virus because that was our business – we developed test kits for caries and sexually transmitted diseases based on the same technology platform,” he said. “Quick tests are the fastest, simplest and cheapest way to identify those infected in a pandemic.”

By mid-2020, its research teams in Hong Kong and the United States had tested hundreds of antibodies to find one that was most sensitive to the new coronavirus.

Indicaid’s production of rapid test kits will increase fivefold as Phase Scientific goes into overdrive

The U.S. government, which in the summer of 2020 began pursuing RAT as its main diagnostic strategy, invited companies including PSI to develop RAT kits and increase production.

“Despite the geopolitical rivalry between the United States and China, we were able to mobilize both our US and Hong Kong staff to develop our RAT around the clock and generate the data we needed for FDA approval,” he said. . “We also had access to infectious disease experts who worked with us in both Hong Kong and California.”

In the United States, its customers include the government of New York City, the search engine giant Google and American schools.

In Hong Kong, after collaborating with the ONCO Medical Laboratory to offer PCR tests, it started early last year to help the government and hospitals roll out a “dual track” method to first screen high-risk groups of people with their RAT kit, followed by the PCR test with more accurate but delayed results.

The work enabled PSI to collect samples from over 22,000 people in Hong Kong to compare the accuracy of their RAT with the gold standard PCR. The results were published in August last year Microbiological spectrum, a peer-reviewed scientific journal.

PSI’s Indicaid rapid test showed an accuracy rate of 84.2 percent, even when the virus level was low, with a 15.8 percent chance of identifying an infected person as negative.

Indicaid competes with products from established multinationals such as Switzerland-based Roche, which claims an 82.5 percent rate for correctly identifying an infected person with a low viral load.

“Covid gave a good lesson to the world about the importance of diagnostics,” Chiu said. “Good self-test kits and self-monitoring of health data can strengthen telemedicine.”

People are waiting to take Covid-19 test at a mobile test station in Hong Kong.  Photo: Felix Wong

When the Hong Kong government approached the RAT to combat the more transmissive Omicron tribe with a plan to distribute RAT kits to the entire population, the PSI plans to fivefold its production capacity to 50 million units per month in June from 10 million in January.

PSI is building a 10,000-square-foot facility in California to focus on developing fluid diagnostic tests for various cancers, and plans to build a similar one in Shenzhen, he said.

After raising about $ 23 million from investors, PSI has reached a dead end in fundraising.

“Our potential investors believe the Covid test boom is a stand-alone phenomenon, so we were stuck in a stalemate over our valuation,” Chiu said. “Since our lively RAT sales in the US have generated cash equivalent to what we were trying to raise, we decided to stop the negotiations for a while.”

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