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FDA clearance

The test runs on the BD Viper LT system and detects 14 high-risk types of human papilloma virus.

The Sentosa SA201 HSV-1/2 PCR test detects herpes virus DNA from oral or anal skin lesions in symptomatic patients.

Centogene opened a Boston office in December and plans to open a lab there in a few months as it awaits an FDA decision on its clinical tool.

The agency cleared the company's C-reactive protein, which is based on its Multi-Array technology used by life science researchers for 20 years. 

Sebia and Janssen Biotech collaborated on the development of the test, which is for assessing patients treated with Darzalex. 

Abbott's CEO said it is going to take a couple of years to get product launches and revenue growth that the company wants to see from its acquisition of Alere.

Executives at two commercial payors said they'd follow CMS' lead when it comes to patients covered under Medicare but beyond that their support for the agency's policy is less clear. 

Bio-Rad received 510(k) clearance for its IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents.

An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.

The three firms each had 510(k) clearances for multiple products from the FDA last month for marketing.

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