PHASE Scientific International has built rapid antigen tests based on the easy-to-use home pregnancy testing mechanism. The device is designed to enable mass rapid testing and tracking for COVID-19. Ricky Chiu speaks with Jumpstart about the tech behind the innovation.
It’s been a busy year at Hong Kong-based biotech startup PHASE Scientific International. The Bill and Melinda Gates Foundation-backed company has spent the better part of 2020 working on diagnostics technology to expand COVID-19 test offerings.
COVID-19 tests enhanced by PHASE Scientific International’s core technology
PHASE Scientific International (PSI) had determined the urgency for rapid testing in COVID-19 by as early as February. With over 20 years of experience in diagnostics, the company’s core development team already had the know-how to build a user-friendly scalable swab-type test. By sourcing the right materials, the company was able to expedite its COVID-19 diagnostics suite.
It now boasts a lineup featuring sample collection kits, an RNA extraction kit, an RT-qPCR test kit, an rapid antibody test and, interestingly, a rapid antigen test.
How does RT-PCR differ from rapid antigen test?
The current standard to detect SARS CoV2 is a technique called Reverse Transcriptase Polymerase Chain Reaction, or the RT-PCR test. This highly sensitive and near-accurate test can deliver a diagnosis from anywhere between few hours to few days, depending on the lab.
But with COVID-19 numbers rising and wave after wave hitting different regions of the world, three to eight hours can still be a long wait for test results. The RT-PCR test is also an expensive undertaking, difficult to sustain for mass testing or regular/frequent testing.
This is where the usefulness of rapid antigen tests, a speedier and more cost-effective cousin to RT-PCR testing, has proved itself.
The RT-PCR test is used to detect targeted genetic material. The presence of pathogenic genetic material from samples indicates the presence of the pathogen itself. It has previously been used to detect other viruses such as Ebola or Zika, according to the IAEA.
The SARS-CoV-2 virus only contains RNA, a single-strand biological molecule, as its genetic material. For RT-PCR testing, the RNA is extracted from collected samples (swab or saliva) to determine the presence of the virus’s RNA, the IAEA explains.
RT-PCR tests are highly sensitive; they will detect the presence of viral RNA even at lower degrees of infection. They are also highly specific, or accurate. But they are not without drawbacks.
“It takes a long time, you need trained technicians to run it, and it takes at most a couple hours to complete,” PSI Chairman and Chief Executive Officer Ricky Chiu explains.
“If you include the logistics and the report to send out, even in Hong Kong where we have so many collection centers, it can still take at least 24 hours before someone can get the result back. And of course, the cost is definitely higher than rapid tests,” he adds. “That’s why this really presents a big gap in the whole COVID-19 detection strategy in Hong Kong.”
Rapid antigen tests do not test for genetic material. Instead, these swab tests rely on the detection of substances called antigens, according to WHO. Antigens are proteins that stimulate the body’s immune responses. The presence of antigens related to SARS-CoV-2 indicate a presence of the virus in the sample.
Unlike RT-PCR tests, however, rapid antigen tests are generally more affordable and can deliver results in less than an hour – or in just 20 minutes in the case of PHASE’s rapid antigen test. They also can be administered outside laboratories, differently from RT-PCR tests which require trained staff.
The rapid antigen test is by no means a replacement for the more sensitive and specific RT-PCR test, a point that Chiu wants to emphasize. Moreover, testing accuracy depends on several factors including the incubation period for the virus, so tests do not guarantee 100% accuracy. But a rapid antigen test can act as a suitable, affordable, time-effective and portable companion to the RT-PCR.
“Both assays have advantages and disadvantages. So [they are meant] to complement each other,” Chiu says. “That’s why in many of the use cases, we always combine these two assays together.”
How does PHASE Scientific International compare to other COVID-19 rapid tests?
The company’s INDICAID COVID-19 Rapid Antigen Test detects SARS-CoV-2 antigens from direct nasal swab samples. Its proprietary technology enables a “specific chemistry that can break open the virus, expose all this protein, and present it in a suitable environment,” Chiu explains.
Users stir their nasal swabs in a buffer solution stored in a dropper bottle. They then squeeze three drops of the solution onto a cassette-like testing device and wait for 20 minutes. Much like a pregnancy test, an indicator panel reports the results based on the appearance of small lines.
PHASE Scientific International’s INDICAID COVID-19 Rapid Antigen Test can report results in 20 minutes, and requires no equipment or training.
What sets it apart, Chiu says, is not the test itself but what has gone into building it. Accurate immunoassay-type tests for pregnancies that don’t require a doctor have been around since the 1970s. The key lies in the material inside.
“I just use the case of Char Siu Fan, barbecue pork rice. Every restaurant can prepare that. But what makes one place better than the others is where you get your [ingredients] so that you can make the best combination,” he explains.
“Because we have over 20 years of experience, we know where you can get the best sources, every single component of this test, the best quality and pricing. And at the same time, we have very mature quality control processes [guaranteeing quality and usability at scale],” he adds.
The test can also detect antigens from lower viral load samples as compared to competitors. Its limit of detections is one of the relative lowest amongst competing products, indicating higher test sensitivity, Chiu says.
He adds that the INDICAID COVID-19 Rapid Antigen Test has received the CE Mark and is currently pending authorization from the U.S. government.
Is there an app to track who has COVID-19?
Hint: There’s an app in the making.
With COVID-19 numbers spiraling out of control all over the world, data-based tracking systems have been essential to bringing some form of order to the chaos. They empower governments and local agencies to get a grip of the potential infections on a granular level. This, in turn, can prove crucial to testing and containment strategies.
To this end, Phase Scientific International is developing a smartphone app to manage results of its point-of-care rapid antigen tests. The company is currently training the app’s AI to validate test results based on a picture of the device taken on the smartphone’s camera. It will also relay results to government departments or employers to help them scale and manage testing among groups of people such as employees.
To build on its usefulness, Phase Scientific International is designing the app to generate a QR code for negative results. Similar to Hong Kong’s QR health code (currently in the works), users can show the code when traveling as proof that they are COVID-19 negative. A little over a month remains for app development to wind up.
PHASE Scientific International – competing against long-standing giants such as Roche and Abbott
PHASE Scientific International is going up against long-standing giants in the medical diagnostics space, such as multinationals Roche and Abbott. These companies are backed by international market reach, and an industrial legacy. Moreover, their global goodwill and brand value carry significant weight in the consumer healthcare space.
The challenge for PHASE Scientific International, Chiu says, is to convince funders and government agencies about their value proposition. But fortunately for the company, data was on its side.
“At the end of the day, data speaks volumes. We were lucky that locally there are companies, and organizations that understand the science and importance of data,” Chiu says.
PHASE Scientific International shares samples with these organizations for them to understand its technology. “And after they understand it and see it for themselves, they become believers, they become our internal champions, they push for adoption. [That’s how] we slowly got to where we are right now.”
The company is also contending with the same supply chains issues that have caused chaos around the world this year. This is where its dual China-Hong Kong base, with R&D and manufacturing based in California, has lent it an advantage.
With lower reported rates of infection, Chiu was able to work around the hurdle of getting samples by shifting research to the U.S. On the other hand, the company sources raw materials globally. The business comes together at its Hong Kong headquarters.
On receiving FDA approval, Chiu intends to build manufacturing capacity in the U.S. so that PSI can sell to U.S. consumers.
“The whole point of startups is to revolutionize the status quo”
Far from communicable diseases, PHASE Scientific ’s mainstay is cancer diagnostics. Its liquid biopsy technology, which helps to screen for late-stage cancer, is a focus area for the company.
Chiu notes that being a small business gave the company the flexibility to take on its ambitious COVID-19 project. Bigger companies have innovations, but they don’t own them – they acquire them, he says. And while working on its COVID-19 products was a “detour of some sort,” it tied back to the company’s original mission.
“All the stuff that we developed here fits in pretty well with our main mission,” Chiu says. “Drawing RNA from patient blood is always going to be a main milestone for this company. The fact that we are working on the [COVID-19] project actually accelerates our understanding of our technology in applying back to the cancer mission.”
Moreover, Chiu ultimately aims to bring about a behavioral change in testing. His vision for PHASE Scientific’s COVID-19 products and especially the rapid tests is to enable frequent testing, and help make it a hygiene factor in day-to-day living during the pandemic. It’s why his rapid antigen test is priced conservatively at HK$120.
It’s not the end of the road for PHASE Scientific’s COVID-19 suite, even with vaccines around the corner. For one, it’s going to take a long, long time for the doses to reach enough people to contain the rate of infection. As the wait carries on, diagnostics continue to hold crucial utilitarian value in fighting the good fight against COVID-19.
The article was written in partnership with Phase Scientific International. Jumpstart is an authorized reseller of Phase Scientific International’s rapid antigen tests. Please visit our ecommerce portal to purchase test kits or contact us at [email protected] with concerns or purchase enquiries
All images courtesy of Phase Scientific International.