A Polish COVID-19 test uses a new DNA technique to get better, faster results and aims to tackle drug-resistant bacteria, too

COVID-19 is a sly and stealthy virus. It flits among the population, undetected. It hides in people who are asymptomatic and disguises itself in others as a common cold or a slight allergy. But if we could flush it out earlier, we could diminish its deadly power.

Testing, tracking and tracing are the crucial steps in containing the virus. A Polish company, Scope Fluidics, is working on speeding up one part of that puzzle – testing.

Scope Fluidics has developed a fast system to detect viral pathogens and bacteria. Called PCR|ONE, the fully automated system can identify – in 15 minutes – up to 20 distinct pathogens and drug-resistant bacteria. The accuracy of the system, which uses polymerase chain reaction (PCR) diagnostics, means that doctors won’t have to wait days for tests to identify COVID-19 cases. It also means that, ideally, people could be tested more often.

“The main advantage of our test is it delivers full information almost instantly,” says Piotr Garstecki, chief executive of Scope Fluidics. “Time is of the essence. We – the civilization as we know it – are at war with the virus.”

A bigger killer than COVID-19

Scope Fluidics’ technology has another important application beyond the pandemic.

The company has created an automatic culturing system called Bacteromic, that helps doctors identify drug-resistant bacteria. More than a million people die each year of infections caused by drug-resistant bacteria. The information provided by Bacteromic could help doctors determine which combinations, or cocktails, of antibiotics and other drugs could fight these killer bacteria.

Antimicrobial resistance, or the resistance of certain bacteria to drugs, was the world’s biggest health threat before the coronavirus pandemic erupted, says Auvo Kaikkonen, a senior life science specialist at the European Investment Bank. “We are running out of options to deal with it,” he says. “Doctors use a hit or miss approach, trying various antibiotics that way may or may not work.”

The EIB, the EU bank, is supporting Scope Fluidics in developing the PCR|ONE system and Bacteromic, with a €10 million quasi-equity investment. The investment is guaranteed by the EU’s InnovFin Infectious Disease Facility, which been expanded by €400 million to tackle the coronavirus pandemic.

A pandemic game changer

Even though speed is an obvious advantage in testing, quick coronavirus tests have a reputation for inaccuracy. Most don’t use PCR diagnostics, which test nose and throat swabs for the virus’s genetic sequence. Instead, they test for specific proteins – or antibodies – produced by our bodies to fight off the infection. The problem is that our bodies can take many days to produce antibodies. While someone may have the virus and be infectious, they may not yet have the antibodies, particularly at the beginning an infection. In contrast, PCR and other genetic methods detect the presence of the virus, with accuracy reaching almost 100%.

 “There is huge demand for this type of device,” says Anna Stodolkiewicz, the EIB investment officer working on the project. “The PCR test is compact and very comprehensive. It can be used not only in hospitals, but in airports, train stations or anywhere the need arises.”

Testing will remain crucial even after a coronavirus vaccine arrives. Large swaths of the population, such as younger people and those not at risk, will simply not be a priority in a first round of vaccinations, which means that the coronavirus is likely to continue circulating. Garstecki says major market researchers expect the  demand for coronavirus testing to peak as late as 2022, even though the vaccine should be broadly available in 2021.

Several tests in one

A major advantage of Scope Fluidics PCR|ONE system is that it can test for several kinds of infection at once.

Imagine a patient arrives at a hospital with an upper respiratory tract infection. A straight test for COVID-19 comes back negative. But doctors still aren’t sure what plagues the patient. PCR|ONE uses molecular information to detect a host of pathogens – not just COVID-19, but other viruses like the flu.

PCR testing has been around for decades. An integral part of genetic testing, PCR diagnostics create millions or even billions of copies of a small DNA sample, making them detectable so scientists can study the sample in detail. Machines put the DNA sample through a series temperature changes, which allows the sample to be copied and amplified.

The problem is that the process can be quite long, taking up to an hour and half or more.

To make the process faster, Scope Fluidics created a custom optical system that sends out short pulses of radiation. That radiation allows the PCR|ONE system to heat water directly, instead of through plastic, making the process of copying and amplifying the DNA samples faster.

The PCR|ONE system uses microfluidic technology, which lets lab technicians to handle small quantities of liquids with great control. These technologies enable the whole process – isolation of the genetic content from bacterial cells or from viruses, separating it from the rest of the sample and performing the genetic analysis – to be done on a small, disposable plastic cartridge. As a special bonus, the PCR|ONE cartridge enables 64 independent genetic analyses to be performed on every single sample.  

The clock is ticking

Founded in 2010, Scope Fluidics grew out of the Institute of Physical Chemistry of the Polish Academy of Sciences. Garstecki, who had spent three years as a post-doctorate researcher at Harvard University, returned to Poland in 2005 and started a research group focusing on microfluidic technology at the Academy.

He started Scope Fluidics in 2010, teaming up with a friend who had previously worked in the pharmaceutical industry. They worked as consultants, until they came up with the idea for their own PCR systems.

The company is still small, with about 50 employees. But the EIB’s Kaikkonen says that Scope Fluidics’ tests are more comprehensive and more advanced than many similar tests being developed or already on the market. “That gives them a chance,” he says.

The company plans its PCR|ONE system to get approval from European regulators before the end of the year, and the approval for Bacteromic a few months later, Kaikkonen says. 

The clock is ticking. As Europe suffers a second coronavirus wave and cases in the United States explode, knowing who is infectious has never been more urgent. “Even massive testing,” says Garstecki, “is an economically a better option than lockdowns.”