To help safely reopen the economy and return life to normal, many researchers and businesses are ramping up efforts to develop reliable and efficient tests for the coronavirus, but they have often been hit with a major stumbling block: The most common testing techniques either take some hours to generate results or require days before a patient can test positive and be isolated from the population.
Seeing how inefficient these two main types of COVID tests -- the PCR and the antibody tests -- can be, a Taiwanese biotech startup decides to dive into developing a rapid antigen test, which is still rare in the market in comparison with antibody test.
Min-Wen Chung, founder of LumiSTAR, says their rapid test detects an infection in patients within 15 minutes -- far more quickly than a regular PCR test does. “Since the launch of this new project, our goal has been to tell the patient as soon as possible if they have the virus.”
Antibody tests are performed to see if a blood specimen contains antibodies, a sign that the human body tries to fight off pathogens like the novel coronavirus; however, it takes a week or two for the body to develop antibodies, founder Yu-Fen Chang says. “During this period of time, some patients might be infecting many others.”
For asymptomatic carriers, antibody tests can be quite helpful, she goes on. But for frontline workers like airport staff, who need to deal directly with a large number of people, antigen tests like theirs stand out as a better option.
Based on the rapid testing technology, LumiSTAR is building an in vitro diagnostic (IVD) device for these workers to screen visitors who can come from anywhere in the world by taking a swab of their throat. It’s an electrochemical gadget like blood glucose meter.
“There are a lot of manufacturers of this kind of meters in Taiwan, so it shouldn’t be a problem for us to find one and work together,” Chung says.
Performed outside the lab setting, LumiSTAR’s point-of-care testing (POCT) technique allows test results to be shared instantly with test performers and later on, healthcare providers for them to take necessary action like hospitalization.
Detecting the virus with a glow
Nowadays, most antigen tests for the novel coronavirus are paper-based strips coated with antibodies. Like rapid influenza diagnostic tests (RIDTs), they have often been criticized for giving false negatives. The same issue was raised around Abbott’s rapid testing system.
Chang says her team abandoned the idea of developing paper tests, which take a matter of minutes for results but has serious limitation in terms of sensitivity and specificity. But still, there are other difficulties lying ahead.
Creating an antigen test often involves a large-scale antibody production in lab animals like mice, rats, and rabbits, but it not only causes unnecessary suffering but ends up prolonging the development of an urgently-needed solution by four to six months.
To avoid sacrificing animals, LumiSTAR turns to E. coli, a type of bacteria commonly found in human intestines, and Chang says now they are able to generate a sufficient amount of antibodies for experiments in just three days.
“With the time spent on antibody production shortened, the cost also drops significantly,” Chung adds.
What’s more, during the manufacturing process, a fluorescent protein-based indicator is attached to all the antibodies, so when they bind to the coronavirus, a chemical reaction occurs and induces a glow with a light color.
By converting the light into electricity, the same reaction that indicates a viral infection can be detected by the IVD device. Chung notes that among many advantages, the device is easy to use and allows high throughput screening.
In their Taipei office, Chang says there are also several “readers” that can examine 96 throat swab specimens at a time and three to four thousand per day.
Looking for new COVID-19 treatments
Before the pandemic, LumiSTAR has been developing an all-optical platform for drug screening, and now, the startup plans to launch a similar platform for COVID-19 treatments.
“A drug works by blocking the virus at multiple points in its life cycle, from the entry into the cell, replication, to reorganization, and our platform examines if the blocking is effective.” Chang says. “If it inhibits viral replication, for example, the fluorescence is weakened.”
The most effective treatment may be like HAART for AIDS, which typically comprises of a combination of multiple antiretroviral drugs, Chung adds.
Rather than repurposing known drugs, LumiSTAR is inclining towards identifying new treatments for COVID-19 -- in a wide array of herbal extracts provided by Taiwan’s Medical and Pharmaceutical Industry Technology and Development Center (PITDC).
Once it discovers an unknown but effective drug, the startup plans to license it to pharmaceutical companies or collaborate with contract research organizations, who conduct clinical trials for pharmas.
“There’s still a long way to go,” Chang says. As VC money flows into Taiwan due to its effective response to COVID-19, LumiSTAR has been actively talking with investors, hoping to scale up its business and make contributions to the society.