mycoplasma

Aiming to receive 501(k) clearance for its M. genitalium detection panel early next year, the firm plans to initially target the assay for use in US hospitals and private pathology centers.

The test has been validated for use with the same full set of female urogenital specimens that are used with Cobas NT/NG testing, as well as for use with male urine. 

The firm plans to submit the Mycoplasma genitalium test to the FDA in 2017 and has entered an agreement with the CDC for test evaluation. 

The test is an improved version of one that was approved three years ago, and runs on the firm's illumigene molecular diagnostics platform.

A University of Alabama, Birmingham team used the Illumina MiSeq platform to perform next-generation sequencing on 15 strains of M. pneumoniae

Roche said this week that the Canadian Health Authority has accepted the use of its PCR-based mycoplasma detection test MycoTool for release testing of an undisclosed Roche biological product.

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.

Roche said this week that the US Food and Drug Administration has accepted the use of its PCR-based mycoplasma detection test for release testing of an undisclosed Roche biopharmaceutical product.

NEW YORK (GenomeWeb News) – Roche said today that the US Food and Drug Administration has accepted the use of Roche's PCR-based mycoplasma detection test for release testing of a Roche biopharmaceutical product.

The new program applies core technologies from across the company to combine one sample-preparation step with one instrument platform for real-time PCR based detection of Mycoplasma, vesivirus 2117, and mouse minute virus.

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Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.

A new report has found that researchers in Africa are still heavily dependent on funding from organizations in the US, Europe, and China, Nature News says.

An article in The Atlantic argues that the progress being made in science isn't keeping pace with the money and time being spent on research.

In Science this week: a CRISPR screen identifies sideroflexin 1 as a requisite component of one-carbon metabolism, and more.