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Roche wins US FDA clearance for Factor II and Factor V test on the cobas 4800 system for the diagnosis of suspected thrombophilia.

M2 EQUITYBITES-February 14, 2018-Roche wins US FDA clearance for Factor II and Factor V test on the cobas 4800 system for the diagnosis of suspected thrombophilia

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Pharmaceuticals company Roche (SIX:RO)(OTCQX:RHHBY) stated on Tuesday that it has passed the US FDA clearance for the cobas Factor II and Factor V Test for use on the cobas 4800 system for testing of patients for inherited thrombophilia.

Thrombophilia is a condition with a predisposition to develop thrombosis (e.g., blood clots) due to either an inherited or acquired defect in the coagulation system. Blood clots may form in either the venous or arterial vascular system and can lead to Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

The company said the cobas Factor II and Factor V test enables laboratories to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, which can reduce hands-on time when testing patients for inherited thrombophilia.

In conjunction, the new cobas Factor II and Factor V Test further complements the recent CE approval of the cobas t 511 and cobas t 711 coagulation analyzers for the central lab, making the company a key partner for laboratories performing coagulation and thrombophilia testing.

According to the company, the cobas Factor II and Factor V Test is a multiplex test, with flexible reporting of both Factor II and Factor V gene mutations. The cobas Factor II and Factor V Test allows labs the flexibility to select the extraction method that best fits their workflow needs as well as allows laboratories to report up to 94 patient samples -and 188 results - per 90 minutes.

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Publication:M2 EquityBites (EQB)
Date:Feb 14, 2018
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