Abacus Diagnostica’s GenomEra Assay Kit Gets CE Mark for Detection of Certain Viruses

Abacus Diagnostica has gained CE mark certification for its GenomEra assay kit, a rapid polymerase chain reaction (PCR) test to detect viruses that cause viral meningitis and encephalitis.

The assay, which delivers results in 70 minutes, can determine whether a meningitis infection is caused by four kinds of common viruses — Herpes simplex 1 and 2 viruses, Varicella-zoster virus, or enteroviruses — using cerebrospinal fluid samples. The test can also detect herpes infections from skin lesion swab samples. 

Viral meningitis is not as severe as bacterial meningitis, but doctors can’t immediately tell if an infection is viral or bacterial, so they usually prescribe antibiotics until a bacterial infection is ruled out.

The rapid PCR test can quickly confirm if an infection is viral, enabling faster diagnosis and avoiding the unnecessary use of antibiotics, the company said.