Four-in-One Test Kit for Detecting Influenza A, Influenza B, RSV and SARS-CoV-2 Set to Launch in November

Abacus Diagnostica (Turku, Finland) is developing the four-in-one test kit and plans to seek CE IVD approval for the multiplexed assay detecting influenzas, RSV and SARS-CoV-2. Since the beginning of COVID-19 outbreak, the company has been developing SARS-CoV-2 diagnostics. In July 2020, its SARS-CoV-2 assay for the GenomEra CDX system received the CE IVD approval for the European market.

GenomEra SARS-CoV-2 is a rapid multiplex RT-PCR test for the detection of RdRp and E genes. RNA extraction is not needed, which dramatically reduces the time and workload of the laboratory personnel. Results are automatically and reliably reported by GenomEra software.The sample preparation is simple and requiring only one quick heating step. GenomEra Test Chips contain all the reagents needed for RT-PCR, which enables performing the testing in laboratories without any earlier experience of PCR. The results from the PCR-based COVID-19 test are available within 75 minutes. Because of the ease and rapidity of the system, many hospitals are using the assay for urgent samples such as testing hospital personnel.

In addition to the COVID-19 assay, the company has been working on a four-in-one test kit for detecting influenza A, influenza B, RSV and SARS-CoV-2. In the Northern hemisphere, the flu season is approaching now on top of the COVID-19 pandemic. The company plans to seek the CE IVD approval for the multiplexed assay detecting influenzas, RSV and SARS-CoV-2. The time frame is set by the approaching flu season. Abacus is aiming for the market launch with well available, CE IVD approved four-in-one assay in November, in a good time before the flu season begins.

“The COVID-19 testing is essential to manage and control the pandemic. When everyone is focused on COVID-19, there is a risk of delays on the diagnosis and treatment of other infections,” said Mr. Erno Sundberg, the CEO of Abacus Diagnostica. “It would benefit the patients and save the resources of the health care system to test more than one pathogen at a time. The flu season awaits in the shade of COVID-19 outbreak, and our new assay will help to bring it on sight as soon as it sets off.”

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