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Reagena Positions Point-of-Care Lyme Test as Alternative to ELISA, Luminex Assays


NEW YORK (360Dx) – Reagena, a Finnish diagnostics company, recently launched a new point-of-care test for Lyme neuroborreliosis that it claims can detect the Lyme-linked chemokine CXCL13 in human cerebrospinal fluid within 20 minutes, making them potential replacements for the most common technology currently used for Lyme testing.

The assay, called ReaScan CXCL13, is run using the Toivala-based firm's immunochromatographic technology platform, and according to CEO Anu Mickels, the technology is "important for our company, as it follows our path of developing and launching unique tests in the area of zoonosis diagnostics."

Reagena obtained a CE-IVD mark for ReaScan CXCL13 last fall, Mickels said.

The firm has introduced a number of such tests in recent years. In 2014, Reagena introduced a similar test for tick-borne encephalitis called ReaScan TBE IgM. It also sells ReaScan tests for Puumala, Dobrava, and Hantaan viruses. All of them form part of the 31-year-old firm's infectious disease testing segment. Reagena also sells life sciences reagents and offers contract manufacturing services.

The company's ReaScan tests are run on its reader of the same name. Hand-held and requiring just two AAA batteries to operate, the company claims its reader requires between 15 and 20 minutes to process a sample. The reader includes test cassettes and vials containing a specific conjugate reagent to which an analyte is bound. The sample is added to the vial, and then transferred to the cassette, where it migrates along a test strip, reacting with capture reagents to form a colored line. The intensity of the resulting line is considered to be proportional to the amount of analyte in the sample. This is subsequently converted into a numerical value.

Given its turnaround time, the company claims that its ReaScan CXCL13 test should support the administration of antibiotic treatment for patients shown to be suffering from borreliosis. That might make it an attractive alternative to the enzyme-linked immunosorbent assays that are currently the preferred choice for diagnosing Lyme in Europe, as ELISA tests can take up to 24 hours to deliver a result. Some companies such as Heidelberg, Germany-based DiaMex and Neuried, Germany-based Mikrogen offer tests for detecting Borrelia antibodies in cerebrospinal fluid using Luminex xMAP technology.

More Lyme tests are currently entering the market based on a variety of platforms. Last month, the US Food and Drug Administration cleared Quidel's Lyme immunoassay for use on its Sofia 2 instrument. The agency cleared the same assay, which detects Borrelia antibodies, on its older Sofia instrument last year. Oxford Immunotec in 2016 acquired the assets of Imugen, a company developing real-time PCR tests for the disease.

Mickels declined to discuss competitors' methods, and also to provide information on pricing. She noted however that for diagnosis of neuroborreliosis, the analysis of both blood and cerebrospinal fluid is necessary.

"CXCL13 is present in human cerebrospinal fluid even before Borrelia antibodies," Mickels said. She also noted that CXCL13 is only considered to be a marker for neuroborreliosis in cerebrospinal fluid, not in serum. Additionally, she noted that the concentration of the marker in cerebrospinal fluid "decreases rapidly after the successful treatment of neuroborreliosis," whereas antibodies remain detectable in blood and cerebrospinal fluid for years. As such, Reagena has positioned its test as an alternative to the most widely used platforms on the market.

"Our assay could be a replacement assay," said Eira Kelo, R&D manager at Reagena. "With our test, you run the assay immediately after receiving the sample, and you don't need to wait for a set of samples to be able to do an ELISA."

Kelo noted that ELISAs are typically run once or twice per week by clinical labs in order to reduce costs. She also said that the biomarker that Reagena decided to detect, CXCL13, is "quite new" in the Lyme testing area, as most tests target antibodies produced by the disease. A number of companies do sell tests targeting CXCL13, though, including Euroimmun, which offers an ELISA-based assay for the marker, and Mikrogen, which sells a test for detecting CXCL13 using Luminex readers.

Kelo described Reagena's offering as being "as sensitive and specific as an ELISA test" due to its technology, as well as being "easy to use and very fast" in comparison to the other tests on the market for detecting CXCL13.

Reagena's ReaScan CXCL13 test was developed in collaboration with partners at the University of Turku in Finland. They worked with Jykka Hytönen, an assistant professor in bacteriology at the university and whom Kelo credited with the idea for the test. Hytönen's research group also validated ReaScan CXCL13. The study was described in the journal Diagnostic Microbiology & Infectious Disease in February.

In it, the researchers compared the ReaScan CXCL13 test to Minneapolis-based R&D Systems' Quantikine CXCL13 ELISA assay by looking at 220 individuals with both tests. According to the authors, there was an "excellent correlation" between the two approaches. As Reagena's offering enables results within around 20 minutes, versus 24 hours for an ELISA, the authors suggested a "reorganization of the diagnostic practice" for testing Lyme, where ReaScan CXCL13 would be used as a first-line test, while retaining antibody-based tests for confirmation.

Hytönen did not respond to an email seeking comment. In a statement though, he noted that "rapidly initiated treatment" following a quick diagnosis would reduce post-treatment symptoms related to neuroborreliosis, while preventing unnecessary treatment from being initiated, as a negative CXCL13 test would enable clinicians to rule out the disease. He also reiterated his position that the test should become the standard of care for diagnosing Lyme in Finland.

According to Mickels, Europe remains Reagena's primary market for the test at this time, though she said that the company could potentially sell ReaScan CXCL13 to clinical labs in other regions. "Market entry outside Europe depends on customer need [and] on the feedback we receive from the international community now that the product has been launched," Mickels said. "We are open for commercialization outside Europe, if and when the feedback is positive."