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Dx Focus: FDA Approves Meridian Bioscience Group B Strep Test; Hologic Cervista HTA System


Meridian Bioscience said this week that it has received US Food and Drug Administration clearance for its Illumigene Group B Streptococcus test.

The Illumigene GBS test uses loop-mediated isothermal DNA amplification, or LAMP, technology to detect Streptococcus agalactiae in enriched cultures of samples from women. The test procedure is simple, highly sensitive, requires no expensive capital equipment, and yields results in less than one hour, the company said. The entire amplification is isothermal and results are read on the company's Illumipro-10 instrument. All reagents and disposables are contained in the test kit and can be stored at room temperature.

The US Centers for Disease Control and Prevention recommendations for GBS, published in November 2010, indicated that a universal culture-based screening method should be performed at 35 to 37 weeks of gestation. The Illumigene GBS test allows laboratories to comply with the CDC recommendations while benefitting from a simplified workflow and greater sensitivity for early diagnosis and proper management, the company said.

Hologic said this week that the US Food and Drug Administration has approved its Cervista HTA (high-throughput automation) system for use with the company's previously approved Cervista human papillomavirus HR test.

The Cervista HPV HR test uses Hologic's proprietary Invader technology to detect 14 high-risk types of HPV that are associated with cervical cancer and precancerous lesions. The newly approved Cervista HTA system automates the DNA extraction and detection steps of the test, allowing users to walk away after loading the instrument and return the next morning to review the test results.

The company noted that more than 200 US laboratories currently run the Cervista HPV HR test manually.