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LabCorp Completes and Publishes a Clinical Study

Published: Thursday, August 09, 2012
Last Updated: Thursday, August 09, 2012
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Publication of a clinical study for the development and validation of a PCR assay for the diagnosis of bacterial vaginosis.

Laboratory Corporation of America® Holdings (LabCorp®) has announced the publication in the July 2012 Journal of Clinical Microbiology of a clinical study that supports validation of a new clinical diagnostic test for bacterial vaginosis.

These studies were completed under IRB approval in collaboration with the Department of Medicine, University of Alabama at Birmingham School of Medicine, and the article was co-authored by physicians and scientists from both organizations.

During the study, quantitative PCR assays were developed for 4 organisms reported previously to be useful positive indicators for the diagnosis of bacterial vaginosis (BV) and a single organism that had been implicated as a negative indicator for BV.

A total of 402 women were enrolled in the study between April and October 2011.

The new test, which is called Bacterial Vaginosis, is currently available as part of the NuSwabsm series of tests.

In 2011, LabCorp introduced NuSwab as a single collection device that improves the convenience and efficacy of sample collection for clinically validated test profiles for targeted women’s health clinical conditions.

The tests are configured to be cost-effective for payers and patients, while providing high quality results to guide diagnosis & treatment.

“Bacterial vaginosis is a common condition, but physicians have limited tools to diagnose it properly,” said Dr. Mark Brecher, LabCorp’s Chief Medical Officer. “This test will help physicians diagnose BV with more specificity and provide better care. Patients are seeing demonstrable benefits from the NuSwab tests, and we will continue to enhance our NuSwab offerings to support better patient care.”

This enhancement to LabCorp’s test menu is an adjunct to its broad women’s health test options, including tests that focus on both screening and diagnosis of disease.

In addition to its women’s health services, LabCorp offers a comprehensive menu of individual tests and test combinations to address specific patient needs.

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