Cepheid Wins FDA Clearance for Xpert Norovirus Test - Analyst Blog

California-based molecular diagnostics company Cepheid (CPHD) has received the U.S. Food & Drug Administration (FDA) clearance for selling its qualitative in vitro diagnostic test – Xpert Norovirus – in the U.S. market.

The Xpert Norovirus test is designed to rapidly detect the presence of highly contagious Noroviruses of genogroup I (GI) and genogroup II (GII) in a patient's body and accurately differentiate between them. The test runs on Cepheid's proprietary molecular diagnostic system – GeneXpert, also acclaimed as the world's leading molecular diagnostic platform.

Last April, Cepheid released the Xpert Norovirus test in the European market, where the test is sold as a CE-IVD product under the European Directive on In Vitro Diagnostic Medical Devices.

Norovirus, a very easily transferable pathogen, globally affects approximately 267 million people and causes over 200,000 deaths each year.

Exposure to Norovirus can be fatal for young children and aged people, who generally have a weak immune system. If not contained at an early stage, rapid spread of Norovirus can result in widespread disease outbreak.

At times of such epidemics, faster detection of infection among those already affected and prevention of further spread of the pathogen is necessary. Cepheid's offering will come of help to clinicians under such circumstances.

Cepheid's Xpert Norovirus test comes as the much-desired solution, with its capacity to determine the presence of Norovirus and accurately isolate the different groups of this pathogen, all within as little as one hour.

Xpert Norovirus will begin shipping in the U.S. from the current month.

Only last week, Cepheid received the FDA go-ahead for the sale of its on-demand molecular test – Xpert Flu/RSV XC, used to detect the presence of Flu A, Flu B as well as respiratory syncytial virus (RSV) infection in a patient's body.

Both these tests have been categorized as Moderate Complexity tests.

The back-to-back FDA approvals for the two aforementioned tests in the U.S. market reflect the potential of the ongoing test menu expansion at Cepheid. We believe such growth-inducing initiatives will result in higher clinical revenues for the company, going forward.

Zacks Rank

Currently, Cepheid retains a Zacks Rank #3 (Hold). Some well-placed stocks worth reckoning in the medical instruments industry are AngioDynamics Inc. (ANGO), EnteroMedics Inc. (ETRM) and Fluidigm Corporation (FLDM). While AngioDynamics and EnteroMedics sport a Zacks Rank #1 (Strong Buy), Fluidigm holds a Zacks Rank #2 (Buy).

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