Skip to main content
Premium Trial:

Request an Annual Quote

Canada Accepts Use of Roche's Mycoplasma Detection Test

NEW YORK (GenomeWeb News) – Roche announced today that the Canadian Health Authority has accepted the use of its mycoplasma detection tool for "release testing" of one of the firm's undisclosed biological products.

It said that the PCR-based test, called MycoTool, which the US Food and Drug Administration accepted for use in December, can replace conventional mycoplasma detection assays based on culture methods and in vitro assays. Such testing methods can take as long as 28 days for results, compared to one day for MycoTool, Roche said.

Mycoplasms frequently are the causes of contamination in biopharmaceutical production, cell therapy, tissue engineering, and vaccine manufacturing, according to Roche. In a statement, Ruedi Stoffel, head of Custom Biotech for Roche, said, "Fast methods, like our new MycoTool test, will greatly enhance the efficiency, quality, and safety in the manufacturing process of pharmaceutical and biological products."

In April 2011, Roche and Lonza announced an exclusive deal for co-distribution of MycoTool.

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more