NEW YORK – Altona Diagnostics said on Thursday that it has received the European Union's In Vitro Diagnostic Regulation certification for the company's PCR-based tests, and the company plans to launch 14 of its molecular test kits through spring of 2025.
The Hamburg, Germany-based firm said that it will launch its AltoStar Parvovirus B19 PCR Kit 1.5 in January for the detection and quantification of parvovirus B19 DNA in a plasma sample. Parvovirus B19 infection causes in children a rash that is known as fifth fever, and it is an infection of concern in transplant and immunocompromised patients.
The firm said that it plans to launch soon afterward another 13 real-time PCR-based AltoStar test kits, including tests that are used to monitor the health of transplant and immunocompromised patients. No further details on the test menu were provided, although the firm noted that it is a developer of molecular tests for infectious diseases.
Altona has also launched in recent years PCR-based tests for other pathogens including a zoonotic orthopoxvirus assay kit in 2022, an HIV-1 viral load assay in 2021, and a SARS-CoV-2 test in 2020.