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Newly Combined Finnish Firm Developing POC Instrument Integrating Molecular, Immunoassay Testing

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NEW YORK ─ By developing an instrument that integrates molecular and immunoassay technologies in one platform, a newly combined firm, comprising three Finnish diagnostic companies, believes it can make it easier for clinicians to run an array of tests at the point of care.

Earlier this month, Abacus Diagnostica, Kaivogen, and Labrox announced their combination to create one firm that will integrate the technologies they've each developed into a next-generation diagnostic instrument.

According to Abacus Diagnostica CEO Erno Sundberg, the companies will combine PCR, antigen, and antibody detection in a near-patient platform that could be launched with an initial menu in 2024 to test for infectious diseases and later to test for cancers.

The Finnish companies are developing the PCR component of the instrument to detect up to 10 bacteria or viruses and to help clinicians detect a specific medical condition when a patient presents with symptoms that suggest numerous possible illnesses.

The instrument's lateral flow immunoassay testing technology, which includes both antibody and antigen detection, is integrated with the same testing instrument, and is being developed to detect cancers and past infections, among other conditions, the firms said.

They are targeting a test turnaround time of less than 30 minutes from sample to result for both technologies, Sundberg said. The firm is currently assessing the sample types needed for its next-generation instrument. For respiratory testing, the instrument is likely to accept nasal and possibly nasopharyngeal swabs, but overall sample requirements are disease specific.

Current near-patient instruments are often deployed by hospitals to obtain rapid results for emergency care, and there are many multiplexed near-patient tests already in the market. Though the testing modalities are complementary, separate instruments and tests are usually deployed to conduct either molecular or immunoassay testing, because combining both modalities is technologically challenging, Sundberg noted.

The combining firms, which are located in Turku, believe that the availability of a broad portfolio of assays on a single, near-patient, multimodal instrument can be an important part of its sales proposition.

Such an instrument would reduce the requirement for firms to purchase and operate numerous instruments that run separate tests, Sundberg said, adding that the group is aiming for a device that will run a broad enough menu to make it compelling for customers to deploy it in multiple locations.

"Besides that, a single instrument that integrates both types of technology [molecular and immunoassay testing] requires one standard operating procedure and the training of a single user," leading to operational savings, Sundberg added.

Colloidal gold or latex beads used for detection in traditional lateral-flow immunoassays can be responsible for lower sensitivity levels than are needed in many applications, he noted, adding that quantifying the results using these technologies can also be challenging. On the other hand, the use of upconverting nanoparticles in the next-generation diagnostic platform solves both issues, leading to high performance and the ability to quantify results.

The new firm's first sales targets are likely to be physician offices and hospital laboratories that support emergency departments, Sundberg said.

The firms are still deciding on the lineup of medical conditions for the instrument's menu, but they expect it will consist of assays to test for around 10 medical conditions. One early candidate is for the detection of C. difficile, an indication for which both PCR and immunoassay testing are needed, Sundberg said.

The new instrument is expected to have numerous testing slots, possibly five, meaning it will be able to run a number of patient samples aligned with the number of slots. The instrument will also have random-access capability, allowing the initiation of testing in one slot while others have started to run tests.

The PCR component of the instrument will also allow multiplexing. For example, a clinician will be able to detect and differentiate among different respiratory pathogens using a single, disposable cartridge, while the remaining instrument slots are used for additional PCR or immunoassay tests.

The companies anticipate high performance for both PCR and immunoassay detection. For PCR testing, sensitivity and specificity are enhanced by "specific properties obtained through time-resolved fluorescence using lanthanide chelates" — technology already available and producing high performance in Abacus' current products, Sundberg said.

For immunoassay testing, the platform will use upconverting nanoparticle lateral flow technology, called Upcon, developed by Labrox and Kaivogen. With Upcon, inorganic crystal particles are excited with low, near-infrared energy leading to high energy emission at the wavelength of visible light, said Kaivogen CEO Leena Kokko. At the wavelength of visible light, an instrument can easily detect target biomarkers in a sample, she said, adding that only the upconverting nanoparticles fluoresce, and there is no measurement interference from off-target biomarkers in the test samples.

Larger investments

The combined company, which is yet to be named, aims to leverage the product development and manufacturing strengths specific to Abacus, Kaivogen, and Labrox. The firms noted that they have engaged in ongoing joint research and development and marketing initiatives. For example, the immunoassay technology that they are integrating into the next-generation testing platform has been developed through a collaboration between Labrox and Kaivogen. Labrox also supplies test readers for Kaivogen's immunoassays.

Further, the firms believe their combination, expected to close in October, will enable larger investments in R&D and sales, generate operational synergies, and expand the overall customer base. Each firm currently has about 30 employees. They had combined annual net sales of €12 million ($15.4 million) in 2020 and expect net sales to rise to €14 million in 2021.

Abacus, founded in 2004, sells CE-marked PCR tests for the diagnosis of infectious diseases, including a standalone test for SARS-CoV-2; a multiplex test that detects and differentiates SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus; and a test for intestinal bacteria, among others.

Abacus has developed updates to its SARS-CoV-2 and respiratory tests that it plans to launch as part of the combined new firm over the next two months, Sundberg said, adding that in the past year, the company sold as many SARS-CoV-2 tests as it could produce.

The firm markets its products through distributors in 25 countries, mainly in Europe and Asia, and sells its instruments and tests primarily to hospital laboratories.

Meanwhile, Kaivogen, which was founded in 2007, develops and manufactures antibody-based immunoassays to detect heart disease, past coronavirus infection, and other medical conditions. For the next-generation platform, the company is developing a test for the diagnosis of early-stage ovarian cancer that could help clinicians differentiate cancer from benign conditions such as endometriosis, Kokko said, adding, "We are using upconverting particle labels to detect glycovariants of proteins with the belief that the ovarian cancer assay will be able to replace invasive biopsies for diagnosis, and be used for the monitoring of patients for recurrence of cancer."

Though the firm has just begun doing clinical evaluations for use of its technology in this application, early results "are showing great promise and a real chance that this can become a diagnostic tool for early cancer detection," Kokko added.

In a recent project for an undisclosed customer, Kaivogen replaced latex particles with the upconverting particles and improved the limit of detection more than one hundredfold to four picograms per milliliter, Kokko said. That's a reflection of the levels of detection the new firm expects to obtain when its immunoassay technology has been integrated into the future platform, she added.

The combined firm has plans to develop assays for the diagnosis of pancreatic, breast, and intestinal cancers for the next-generation platform.

Labrox, founded in 2011, manufactures laboratory-based microplate readers and point-of-care instruments and readers. The company sells its equipment to life-science industry OEMs that integrate the equipment into their products and brands. The firm's CEO Henri Sora said the new company expects to offer an affordable testing platform, partly because of the simplicity of its design and low cost of production. "One of the main points of the merger is that our combined production knowledge will lower costs quite significantly," he said.

The group is not disclosing specific information about the anticipated cost of its instrument, but Sundberg said it will be priced "in the thousands" of dollars, and individual tests will be priced to be competitive with other tests in the market.