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FDA Clears Roche's Chlamydia/Gonorrhea Assay

NEW YORK (GenomeWeb News) – Roche today announced its cobas CT/NG Test for Chlamydia trachomatis and Neisseria gonorrhoeae infections has received 510(k) clearance from the US Food and Drug Administration.

The PCR-based multiplex dual probe assay runs on the cobas 4800 platform and is complementary to the cobas HPV Test, which was cleared by FDA last year. The test is for detecting CT and NG infections in symptomatic and asymptomatic patients using urine in men and self-collected vaginal swabs.

It received CE marking in 2009.

Citing a report from the US Association of Public Health Laboratories and Centers for Disease Control and Prevention, Roche said that male urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing. The specimen types are considered a progressive option for CT/NG screening because of high sensitivity. Additionally, they provide less invasive and less painful options to urethral or endocervical samples and may promote screening compliance, Roche said.

A trial for the test confirmed that self-collect vaginal specimens and male urine specimens show increased sensitivity and specificity compared with other specimen types in populations with low- and high-disease prevalence, the company added.

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.