NEW YORK – With flu season approaching, Finland's Abacus Diagnostica has decided to roll out a multiplex RT-PCR test for SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The assay should have a CE-IVD mark by November and will serve the molecular diagnostics firm's growing European client base, according to CEO Erno Sundberg.
"This is a good fit for labs that are worried about running out of testing capacity when flu season hits," he said.
The launch will build on the CE-IVD marking of a three-plex assay for SARS-CoV-2 in July, a test that has in some ways been a breakthrough for the firm as labs have adopted its GenomEra platform to run it and other tests. The assay contains markers for the RdRp and E genes, plus a control.
"COVID-19 has financially been a jackpot for us," said Sundberg. "Our revenue has increased by 10-fold compared to last year and growth has turned our business very profitable." He did not break out specific revenues for the privately held firm.
Abacus had achieved a CE-IVD mark for an earlier incarnation of its flu test, covering influenza A, influenza B, and RSV, in 2019. Prior to that, the company also launched in vitro diagnostic tests for norovirus and Clostridium difficile, reaching customers mainly via distributors. 2020 by all metrics though has been transformational. The company grew to 17 people from 11 staffers, and in July closed a round of crowdfunding that netted it €1.5 million ($1.8 million).
Its Flu A/B + RSV Test served as a foundation for the SARS-CoV-2 test it launched this year. "That was the basis for the COVID-19 test, because it relies on the same sample, measures similar RNA viruses, so it was quite an easy modification for the assay," Sundberg said.
Abacus Diagnostica was founded in 2004 to commercialize technology developed at the University of Turku, located in Finland's third largest city and a life sciences hub for the country. Its GenomEra CDX Platform relies on fluorescent lanthanide labels and a time-resolved detection approach to detect results with no signal interference from clinical samples. The consumables for the system consist of disposable plastic chips containing all necessary PCR or real-time PCR reagents, meaning there is no need to separately handle the reagents. Samples are analyzed using the company's instrument and software and samples can be traced via barcodes.
Abacus obtained a CE-IVD mark for the GenomEra CDX Platform in 2010. Sundberg declined to provide a price for the system or its tests, but said it sits at "the low-cost end" of the molecular diagnostics market. He noted that competitors including Cepheid, Roche, and BioMérieux have developed multiplex tests for SARS-CoV-2, influenza A and B and RSV, but said that Abacus's products have some technology advantages over its rivals.
The firm's dry chemistry in particular distinguishes Abacus in the market. "What others accomplish by engineering, we accomplish by chemistry," he said. "The core innovation is the dry chemistry plus the fluorescent labels that provide improved sensitivity over traditional labels."
Its current SARS-CoV-2 assay has a turnaround time of about 75 minutes, which has allowed central hospital laboratories in Finland to use it as a test for frontline healthcare workers and newly admitted patients, he said. Sundberg said that over half of Finland's central hospital labs are already using the system. Some university hospital labs have also adopted the GenomEra platform so that they can use the SARS-CoV-2 test as a supplementary diagnostic, he said. The company has also seen uptake of the platform and accompanying test in other markets it serves via distributors in Europe, the Middle East, and Asia.
Demand rose for the SARS-CoV-2 test even prior to gaining the CE-IVD mark in July, he noted, as some countries allowed research products for emergency clinical use. What this success has meant, however, is that the company has had to grapple with the same supply chain issues that have constrained even the largest players in the European molecular diagnostics market. Abacus Diagnostica managed these issues by increasing its production of consumables and instruments, allowing it to build out a stock of products for new customers. Consumable production is up 2,000 percent, instrument manufacture up a thousand percent.
"The supply chain has remained somewhat challenging but we have managed the situation pretty well, and our key suppliers have been able to deliver enough raw materials," noted Sundberg.
Yet because of peak demand from current distributors the company is not taking on new distributors, he acknowledged, meaning that expansion to North America is off the table for now. "At the moment, we are pretty much sold out," Sundberg said. "We want to serve our current customers and are doing our best to deliver enough tests and instruments."
However, the momentum the company has picked up from sales of its SARS-CoV-2 test has prompted it to make plans for a next-generation version of the GenomEra platform.
"We are redesigning the consumables and instruments with modern technology," said Sundberg. "We are aiming to do everything in a smart way and to improve usability." The envisioned next-generation platform will increase multiplexing to 10 from five and offer reduced turnaround time and costs. In addition to supporting PCR tests, it will also be capable of performing quantitative immunoassays such as serological tests for SARS-CoV-2, he said.
He did not provide a timeline for when the next-generation system will become available.
There are also other assays in the pipeline, such as a test for viral meningitis. The assay will detect enterovirus, herpes simplex virus 1, herpes simplex virus 2, and varicella zoster virus, he said, and the company aims to obtain a CE-IVD mark for the test by the first quarter of 2021. The company initially had hoped to have the assay out this year, but reshuffled its plans when the COVID-19 pandemic hit.