New GenomEra® assay kit for rapid detection of viruses causing viral meningitis CE-marked
Abacus Diagnostica launches new GenomEra® assay kit for rapid detection of viruses causing viral meningitis
Abacus Diagnostica, a Uniogen company and Finnish frontrunner in molecular testing, is launching a new rapid PCR test in the European markets for the fast identification of viruses causing viral meningitis and encephalitis. The CE-marked GenomEra® assay kit (HSV-1/2, VZV + EV Assay Kit) allows healthcare professionals to determine in 70 minutes whether a meningitis is caused by the four most common viruses, allowing proper treatment to be started immediately and unnecessary use of antibiotics avoided. The test can also detect herpes infection (HSV-1 and HSV-2) from skin lesion swab samples. The assay kit has recently received European CE marking for In Vitro Diagnostic (IVD) medical devices according to the requirements of EU Directive 98/79/EC (IVDD).
“The test detects the four most common viruses causing viral meningitis from cerebrospinal fluid sample in just one test. In the traditional diagnostics of meningitis, separate assays are used, and the time from sampling to results often takes several hours, which can delay the diagnosis and thus also lead to the unnecessary use of antibiotics,” Erno Sundberg, CEO of Abacus Diagnostica tells.
Viral meningitis is typically caused by Herpes simplex 1 and 2 viruses, Varicella-zoster virus (VZV), or enteroviruses (EV). Although viral meningitis is not as severe as acute bacterial meningitis, which often requires urgent hospital care, some patients seek treatment for unpleasant symptoms. The doctor cannot determine whether the meningitis is caused by a virus or bacteria on the basis of the symptoms alone, so the patient is usually started on antibiotics until bacterial meningitis is ruled out.
Developed and manufactured in Finland, the GenomEra® test system can be used in almost any healthcare unit, as it is easy to use requiring virtually no special expertise. The automated test system consists of test chips and a GenomEra® CDX instrument that automatically interprets the test result after short and simple sample processing.
Clinical trials in three European hospitals in April-May 2022 have demonstrated that the assay kit provides rapid PCR test results with high sensitivity (92.3% probability that the test is positive if the patient has HSV-1/2, VZV or EV infection) and excellent accuracy (99.9% probability that the test is negative if the patient does not have HSV-1/2, VZV or EV infection).
“We started developing the test as early as 2019, but during the COVID-19 pandemic, the focus of our product development shifted to the development of COVID-19 rapid tests. On the other hand, thanks to this extra time, the results were even better. We have launched a test that is easy to use, has shown superior specificity in performance evaluations and combines the simplicity of the assay process with the excellent sensitivity of the PCR method. I would like to take this opportunity to thank our talented Abacus Diagnostica team for the great outcome,” Sundberg says.
For more information, please contact:
CEO, Abacus Diagnostica Oy
+358 40 727 8690
Abacus Diagnostica in brief
Abacus Diagnostica is a frontrunner in molecular testing and rapid PCR tests, offering systems for diagnosis of infectious diseases such as coronavirus, influenza and intestinal bacteria. The automated test system developed and manufactured by the company consists of test chips, instrument and software interpreting the results. While Abacus Diagnostica’s customers are typically hospital laboratories, test system can be used in any healthcare unit, as it is easy to use and requires virtually no special expertise. The company is headquartered in Finland and its products are sold through distributors in more than 25 countries, mainly in Europe and Asia. Established in 2004, the company is now part of Uniogen Oy, a global pioneer in clinical diagnostics, point-of-care testing and instruments for life sciences, based in Turku, Finland.
Uniogen in brief
Uniogen is a global pioneer in clinical diagnostics, point-of-care testing, and instruments for life sciences. Our goal is to enable the right diagnosis and care at the first patient appointment. With point-of-care testing for infectious diseases and cancer diagnostics, among others, we provide patients and healthcare with faster, easier, and more cost-effective diagnosis.
Our GenomEra rapid PCR tests for COVID-19 are currently a significant part of our business. Through contract development and manufacturing, we also provide laboratory instruments and tests for e.g. heart diseases and detection of coronavirus antibodies. Our Upcon system, consisting of brightly luminescent upconverting nanoparticles, instruments, and software, brings great benefits to point-of-care testing. We are also developing the first total solution for point-of-care testing on the market that allows both antibody and PCR testing and thereby diagnostics for several diseases to be performed simultaneously with a single, versatile, and easy-to-use device -virtually in any healthcare setting and without special expertise.
Uniogen was established when Abacus Diagnostica, a frontrunner in molecular testing and rapid PCR tests, Kaivogen, a specialist in immunoassays and antibody testing, and Labrox, an innovator of high technology laboratory instruments and diagnostic readers, joined forces in the beginning of 2022. The company is headquartered in Turku, Finland and employs approximately 100 life science professionals. Uniogen’s products are sold in about 100 countries around the world. In 2021, the combined annual net sales of the three companies forming Uniogen was approximately EUR 15 million.