The need for speed
As a trio of articles from our May 2020 issue of DDNews illustrate below, speed is of the essence with tests for the novel coronavirus causing our current global pandemic—not just in terms of getting diagnostic tools into the hands of labs and clinicians but in terms of how quickly they can do the job of diagnosing infection by the virus that causes COVID-19.
To view the May issue online (as a PDF file) or download it, click here.
A rapid testing option for COVID-19
VTT and MeVac work together to develop virus detection
HELSINKI, Finland—Last month, VTT Research Center of Finland announced a partnership with Meilahti Vaccine Research Center (MeVac) to develop a rapid test for coronavirus using a new test method based on the detection of viral antigens in nasopharyngeal samples for the COVID-19 virus. With this test, the companies are hoping to provide healthcare professionals with an accurate, fast and resource-efficient method of detecting coronavirus infections early. Using the new test, results would be returned in 15 minutes or less, and would be considerably more cost-efficient than current testing methods.
“As the situation with the epidemic began to worsen internationally, we started looking for solutions within our area of excellence. We have expertise in antibody development and production as well as previous experience in designing diagnostic tests. It was an easy decision for us to start working on the COVID-19 antibody,” says Dr. Leena Hakalahti, research team leader for biosensors at VTT.
HUS Helsinki University Hospital’s research is also playing an important role by investigating antibody development, as well as providing the samples taken from COVID-19 patients for use in the development of the rapid test. In cooperation with the team at VTT, this project is being led by Olli Vapalahti, professor of virology at the University of Helsinki, and Anu Kantele, director of MeVac Vaccine Research Center and professor of infectious diseases at the University of Helsinki. The team also believes this development could further aid the fight against COVID-19.
“As the research progresses, we will explore the possibility of using the developed antibodies not only for testing, but also for the treatment of coronavirus disease,” noted Vapalahti.
VTT originally began the research to develop new antibodies to SARS-CoV-2 virus antigens with internal funding, but the project is now actively seeking additional funding and partners for the development of the rapid test. While work on the rapid test now focuses specifically on COVID-19, once the rapid testing technology is completed, the same development process could easily be used to diagnose other viruses.
“Increasing the testing capacity plays a key role in monitoring the progress of the epidemic, but current testing methods require a lot of time and resources which limits the capacity. The purpose of the rapid test is to enable growing the testing capacity and ensuring the availability of tests even as the epidemic continues,” commented Dr. Jussi Paakkari, research area vice president at VTT.
Diagnostics and digital health are VTT’s core areas of expertise, with approximately 80 people working on related topics across Finland. VTT also has extensive experience in designing tailored diagnostic tools for various diseases, and its technology portfolio includes everything needed to develop single-use diagnostic tools and systems. The company is able to combine antibody expertise, mass production of test strips and powerful data analytics. The manufacturing of the COVID-19 tests and their analysis equipment would be done in Finland by VTT and Finnish companies, but this test has the ability to serve communities worldwide. VTT expects the first versions of the test to be available in the fall.
Bringing speed to coronavirus testing
BillionToOne says new COVID-19 protocol could unlock a million tests per day
MENLO PARK, Calif.—The precision diagnostics company BillionToOne recently announced that it had developed what it says is a highly accurate and cost-effective novel COVID-19 test protocol, one capable of unlocking more than one million testing capacity per day in the United States alone.
“We’ve all seen the impact this pandemic has had on every aspect of our daily lives,” said Dr. Oguzhan Atay, CEO of BillionToOne. “From the loss of lives to the damage to the economy to the strain on the healthcare system, the coronavirus has delivered a crippling blow to the country. We’re honored to be on the front lines of this fight against the pandemic, and we’re certain that this unique technology will help save lives and stop the spread of the virus.”
As the company explains, current quantitative PCR (qPCR) methods do not support the testing volume needed for rapid COVID-19 response. Additionally, the extreme surge in demand for the same reagents and instruments have caused multiple bottlenecks in the supply chain.
Using the patent-pending qSanger spike-in and proprietary machine-learning algorithms, BillionToOne’s COVID-19 assay takes advantage of the 30 times higher throughput Sanger sequencing capacity (1,536 samples on qSanger at a time vs. 48 samples on qPCR at a time). According to the company, qSanger technology unlocks each Sanger instrument to automatically perform 3,840 tests per day, and there are hundreds of instruments available from the Human Genome Project alone, enabling increased testing capacity.
The BillionToOne COVID-19 test uses different sets of instruments and chemicals from existing COVID-19 tests, enabling labs to access unused capacity. BillionToOne sequences the virus’ genome—reportedly making the test extremely sensitive and specific, on par with or better than other COVID-19 tests available. The company says the test is easily adoptable at any labs with Sanger sequencers, with minimum training.
“I’m extremely grateful to the hard work and dedication of the BillionToOne team to get this vital resource developed so quickly,” Oguzhan said. “Our mission here at BillionToOne is to remove the fear of the unknown by making powerful molecular diagnostics available to all. We believe our COVID-19 test can contribute greatly in removing the unknowns from the COVID-19 crisis response.”
BillionToOne is a precision diagnostics company with a mission to make molecular diagnostics more accurate, efficient and accessible for all. The company’s patent-pending QCT molecular counter platform is the only technology platform that can accurately count DNA molecules to the single-count level. BillionToOne's first product, UNITY, is reportedly the first and only noninvasive prenatal screening that tests fetal cell-free DNA for cystic fibrosis and spinal muscular atrophy through a single sample of the mother’s blood.
A new COVID-19 test from UCSF and Mammoth
Scientists at the University of California, San Francisco (UCSF)—along with researchers at Mammoth Biosciences—have developed what they say is an inexpensive new test that can rapidly diagnose COVID-19 infections.
The partners say that the new test—officially named the SARS-CoV-2 DETECTR—is easy to implement and to interpret, and requires no specialized equipment, which could make the test more widely available than the current crop of COVID-19 test kits, if it were to receive regulatory approval—UCSF researchers are clinically validating the test in an effort to fast-track the approval through the emergency use authorization path.
“The introduction and availability of CRISPR technology will accelerate deployment of the next generation of tests to diagnose COVID-19 infection,” said Dr. Charles Chiu, a professor of laboratory medicine at UCSF and co-lead developer of the new test, which is described in a paper published April 16, 2020, in the journal Nature Biotechnology.
The new SARS-CoV-2 DETECTR assay is among the first to use CRISPR gene-targeting technology to test for the presence of the novel coronavirus. Since CRISPR can be modified to target any genetic sequence, the test kit’s developers “programmed” it to home in on two target regions in the genome of the novel coronavirus. One of these sequences is common to all “SARS-like” coronaviruses, while the other is unique to SARS-CoV-2, which causes COVID-19. Testing for the presence of both sequences ensures that the new DETECTR tool can distinguish between SARS-CoV-2 and closely related viruses.
Much like the diagnostic kits currently in use, the new test can detect the novel coronavirus in samples obtained from respiratory swabs. However, the new test is able to provide a diagnosis much more quickly. While the widely used tests based on polymerase chain reaction (PCR) techniques take about four hours to produce a result from a respiratory sample, the new DETECTR test takes only 45 minutes, rapidly accelerating the pace of diagnosis.
Another key advantage of the new DETECTR test is that it can be performed in virtually any lab, using off-the-shelf reagents and common equipment. This stands in stark contrast to PCR-based tests, which require expensive, specialized equipment.