bioMérieux has announced the launch of BIOFIRE^® MYCOPLASMA, an innovative test for mycoplasma detection in pharmaceutical products used for biotherapeutics (antibodies, hormones, cell and gene therapies, etc.).

Mycoplasmas are bacteria found during biopharmaceutical manufacturing. Some species of mycoplasma cause respiratory and genital infections, thus representing a health hazard. They are difficult to detect creating a major risk during industrial production processes.

BIOFIRE MYCOPLASMA is an innovative, rapid and very easy-to-use molecular biology test. This is because the DNA extraction, amplification and detection steps are fully automated and may be performed outside of the laboratory by nearly anyone after simple training.

The BIOFIRE system used with this test includes all the reagents and controls necessary for the analysis in a single pouch, making it possible to perform the test close to where the samples are taken.

Delivering results in less than one hour, BIOFIRE MYCOPLASMA facilitates biopharmaceutical product controls and saves precious time during the production of therapies that are most often used by patients with a serious disease, whose critical condition may require them to receive treatment as quickly as possible.

Mycoplasma detection has traditionally been based on tissue culture techniques, which take 28 days to deliver results, or on a PCR molecular biology method that provides results in just a few hours but must be performed in a specialized lab, requiring high-level expertise.

The new BIOFIRE MYCOPLASMA test, which is available in the United States, will be launched in some countries in Europe and the Asia-Pacific region in the coming months.