NEW YORK – A rapid molecular diagnostic instrument from South Korea-based SD Biosensor has shown high sensitivity and low rates of invalid results in recent evaluations, putting it on par with competing molecular platforms. The system, called the Standard M10, is currently in use in a handful of countries, but the firm is now planning for a global expansion through its recent acquisitions in the US, Brazil, Italy, and Germany.
During the early days of the pandemic, SD Biosensor was among the top manufacturers of COVID-19 test kits in South Korea, according to a local press report, marketing both antigen tests and RT-PCR test kits.
Outside of South Korea, SD Biosensor obtained Emergency Use Authorization for a SARS-CoV-2 assay kit from the US Food and Drug Administration in April 2020. It also formed a global distribution agreement with Roche for its Standard Q rapid COVID-19 antigen tests, which were subsequently granted EUA and branded the Pilot COVID-19 At-Home Test. (A separate antigen test, called the Standard Q COVID-19 Ag Home Test, was recalled in the US in February 2022 after the firm said it had been illegally imported and had not received EUA. SD Biosensor noted at the time that there had been no confirmation that the tests had been distributed to consumers.)
The firm has since branched into instrument manufacturing, launching a modular, all-in-one molecular diagnostic system called the Standard M10 and targeting customers in clinics, hospitals, and laboratories.
Jiwon Lim, SD Biosensor's team leader for public relations, said in an email that SD Biosensor obtained the CE mark and launched the Standard M10 in Europe in September 2020.
The firm then obtained approval from the Brazilian Health Regulatory Agency, or ANVISA, and began supplying the Standard M10 in South America as well as registering it in countries in Asia. The system was granted approval by the Korea Ministry of Food and Drug Safety along with an RT-PCR assay cartridge for SARS-CoV-2 in January 2022.
With the firm boasting end users in South Korea, Italy, Denmark, Germany, Brazil, and Thailand, the system is now receiving favorable evaluations by these end users.
In a study published online last month in the Journal of Clinical Virology, a team at the San Martino Policlinico Hospital and the University of Genoa compared SD Biosensor's flu, RSV, and COVID assay to a respiratory panel from Seegene called the Allplex SARS-CoV-2/Respiratory Panel 1.
The study found that for a total of 1,019 samples, the positive percent agreement of the Standard M10 assay was 100 percent, 96.6 percent, 97.3 percent, and 99.4 percent for the flu A, flu B, RSV, and SARS-CoV-2 targets, respectively. The corresponding negative percent agreement was 99.7 percent, 100 percent, 100 percent, and 98.4 percent, respectively.
"What I really liked is that SD Biosensor and its Italian subsidiary, Relab, were not 'scared' of putting themselves out there and asked us to perform an independent evaluation of their kit in a large number of samples," said Alexander Domnich, corresponding author on the JCV study, who noted in an email that his team is part of a regional reference laboratory for viral infections and frequently evaluates molecular diagnostic assays.
Overall, the assay was "highly accurate," but more importantly, "our results were in line with the performance specifications declared by the manufacturer," which he said is not always the case in his experience.
Furthermore, "being a public health physician, I pay a particular attention to the cost-effectiveness issues," Domnich said. In his team's study, the Standard M10 had only three invalid results out of the 1,019 assays.
"When you have an invalid result, you have to repeat RT-PCR, and this may compromise both the speed and efficiency of the lab," Domnich said, as well as the overall cost-effectiveness profile.
Once the study was finished, the team continued using the Standard M10 to test urgent samples for differential diagnosis of SARS-CoV-2, flu, and RSV, he said. "I also hope to use it for next season's epidemiological and vaccine-effectiveness studies."
Separately, another group of Italian researchers at Bambino Gesù Children's Hospital in Rome and the University of Milan compared a Standard M10 SARS-CoV-2 test to the Cepheid Xpert Xpress SARS-CoV-2 test.
In a study published in Frontiers in Microbiology in November, the team showed the SD Biosensor system was "remarkably and consistently comparable" to the Cepheid GeneXpert with an overall agreement of 98 percent and similar time to results in an assessment of 616 samples from pediatric patients. The team also noted that when the Xpert Xpress SARS-CoV-2 results were considered as the reference, the Standard M10 SARS-CoV-2 assay demonstrated 96.5 percent sensitivity and 98.4 percent specificity.
And, in work published in the Korean journal Infection & Chemotherapy last year, a team at Seoul National University Bundang Hospital also compared the Standard M10 test to a routine lab-based test from Kogene using 80 samples, finding sensitivity and specificity of the M10 assay to be 100 percent.
Jeongsoo Park, corresponding author on that study and an associate professor of laboratory medicine at the hospital, said in an email that his team had been doing emergency testing with the GeneXpert system but encountered some obstacles due to limited importing of the reagents.
In search of alternatives, they conducted the evaluation of the Standard M10. "There was no difference in sensitivity and specificity," Park said, adding that the lab is now continuing to use both the M10 and the Xpert, but that the cartridge price for the M10 is lower.
A letter to the editor published in the Annals of Laboratory Medicine in January from a different team in Korea suggested the SARS-CoV-2 test had some limitations in detecting low viral loads when compared to the GeneXpert. In regard to this study, Park said the results applied to Ct values above 30, which he said indicates a low level of infection that is typically seen after treatment and may not be as clinically relevant in emergency care situations.
The sample-to-answer Standard M10 can perform amplification using isothermal loop-mediated amplification (LAMP) or RT-PCR and can test up to 12 samples in parallel, Lim said.
The sample-to-results time for the LAMP-based assay cartridges, also called Turbo, is 30 minutes, while the time to results for the RT-PCR assay cartridges is 60 minutes.
The Standard M10 is also modular, with a tall and thin touchscreen console and a module instrument that is roughly the size of a desktop computer. Up to eight module instruments can be operated from one console to increase throughput.
For sample prep, Lim said that while many systems save time by skipping extraction or only performing lysis, the Standard M10 uses a patented cartridge structure to perform the entire extraction process in a short time, which in turn improves the sensitivity of the testing.
SD Biosensor has also improved the efficiency of the RT-PCR reaction by developing and using enzymes customized for the system, Lim said. And, the Standard M10 also has sensors to monitor temperature and optical signals in real time, with optimized protocols and analysis algorithms, she said.
Currently, the Standard M10 test cartridge menu includes the M10 SARS-CoV-2 test, which is CE marked and KMFDS approved, as well as seven other CE-marked assays.
These include the SARS-CoV-2 Turbo test, an assay for multidrug-resistant tuberculosis, a combined test to detect Mycobacterium tuberculosis complex and non-tuberculous mycobacteria, a test for human papillomavirus (HPV) strains 16 and 18 as well as 12 other high-risk strains, and an assay for Clostridium difficile.
The firm also has the CE mark for a respiratory viral panel cartridge that detects influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2, and an arbovirus panel that detects dengue virus, Zika virus, chikungunya virus, yellow fever virus, and West Nile virus.
In addition, SD Biosensor has developed a research-use-only monkeypox/orthopox test cartridge for the Standard M10.
Lim said that SD Biosensor is also working on a next-generation version of the Standard M10 using "Fast RT-PCR," which will reduce the run time by half and also detect 16 targets including an internal control. The firm expects to make this system available in the US in 2024.
Development of the Standard M10 has been supported by diagnostics organization FIND, which in late 2021 announced it had chosen four companies, including SD Biosensor, to develop point-of-care molecular platforms for infectious diseases out of 47 applications and would invest $21 million in these technologies.
At the time, the name of the SD Biosensor molecular platform was not disclosed, but FIND said it had the capability to multiplex up to 12 targets per test and would be validated for tuberculosis testing.
Criteria for the funding included the technical performance of the platform, the added value to the diagnostics market, suitability for use in decentralized settings, and affordability for low- and middle-income testing, FIND said at the time.
Plans for global expansion
SD Biosensor has been expanding globally of late, with acquisitions in Europe and the US signaling strategic interest in these markets.
Of particular note, just last month, SD Biosensor and SJL Partners completed the acquisition of Cincinnati-based Meridian Bioscience for $1.5 billion. Under the terms of the merger, Meridian, which has been around for decades and is well established in the US diagnostics market, will continue to operate as an independent entity.
Lim said that SD Biosensor now plans to quickly enter the US market "based on Meridian Bioscience's FDA regulatory and approval capabilities."
The firm is currently undergoing the FDA regulatory process to launch the Standard M10 in the US, she said. Although it is hard to predict a marketing clearance date, Lim said SD Biosensor anticipates good uptake here, as the point-of-care molecular diagnostic market is growing.
Speaking at the JP Morgan Healthcare Conference in San Francisco in January, SD Biosensor Chief Operating Officer Serena Cho also said the firm plans to compete with global in vitro diagnostics companies through its entrance into the US market as well as through additional M&A and expansion to direct sales in 10 countries in 2023.
In a statement published by the company concurrent with her presentation, Cho further said of the Meridian acquisition, "By combining the main bases, production plants, and distribution networks of the two companies, we will be able to cover the global market, including the US," emphasizing that the purpose of the acquisition was to accelerate entry to the US market utilizing local production and distribution networks and expertise in FDA registration.
Cho said that SD Biosensor also plans to build an automated manufacturing facility in the US "to respond to local demands."
Lim said that SD Biosensor does not expect the Standard M10 to compete with molecular diagnostic instruments from Meridian, as SD Biosensor has expertise in respiratory infectious disease and Meridian has expertise in gastrointestinal disease diagnostics.
"In this way, the two companies' different specialized portfolios will be strengthened and complementary to each other," Lim said.
In addition to the Meridian deal, since 2021 SD Biosensor has also acquired the medical technology distribution firms ECO in Brazil, Bestbion in Germany, and Relab in Italy.