View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
October 19, 2017updated 23 Oct 2017 4:08pm

US FDA clears Quidel’s new diagnostic assay for RSV and hMPV

Diagnostic testing solutions provider Quidel has obtained marketing approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) Assay for the diagnosis of RSV and/or hMPV infections.

By GlobalData Healthcare

Diagnostic testing solutions provider Quidel has obtained marketing approval from the US Food and Drug Administration (FDA) for its Solana respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) Assay for the diagnosis of RSV and/or hMPV infections.

Indicated for use in the Solana instrument, the assay is designed to detect nucleic acids extracted from nasal and nasopharyngeal swabs of patients having signs and symptoms of a respiratory infection.

The assay uses a new Reverse-Transcriptase Helicase-Dependent Amplification (HDA) for the generation of a rapid and accurate test result within 45 minutes.

Quidel president and CEO Douglas Bryant said: “We are pleased to introduce an additional innovative, rapid testing solution that addresses the leading cause of viral respiratory infections in both the young and elderly, RSV and hMPV.

“The easy-to-use molecular test does not require prior RNA extraction.”

“This economic and focused approach to testing to detect and differentiate these infections replaces expensive syndromic panels or laboratories capable of performing high-complexity testing.”

Bryant further added that the easy-to-use molecular test does not require prior RNA extraction.

The ability of Solana to process up to 12 samples in a single 45-minute run is expected to offer time-saving and workflow advantages in moderately complex settings.

With CE-Mark obtained in August this year, the RSV + hMPV assay expands the firm’s Solana platform, which includes tests for the detection of various infections such as Clostridium difficile, Group A β-hemolytic Streptococcus, Herpes simplex virus 1 (HSV-1), influenza A and B, and trichomonas.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU