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Quidel

NEW YORK (GenomeWeb) – Quidel has received US Food and Drug Administration 510(k) clearance for its human parainfluenza virus molecular diagnostic test, the firm said today.

NEW YORK (GenomeWeb) — Quidel said on Monday that it has received 510(k) clearance from the US Food and Drug Administration to market its Lyra Adenovirus Assay, a real-time PCR test for the qualitative detection of human adenovirus viral DNA from nasal and nasopharyngeal swabs.

NEW YORK (GenomeWeb) — In cases where US Food and Drug Administration-cleared assays do not exist, clinicians often use their own lab-developed PCR assays to test for conditions of interest. This process can involve separate extraction and amplification steps, and extensive hands-on time.

NEW YORK (GenomeWeb) — Researchers at Johns Hopkins University have performed the first validation of the Cepheid Xpert Flu assay in a population of emergency room patients with acute undifferentiated respiratory illness.

NEW YORK (GenomeWeb) — The US Food and Drug Administration has cleared for marketing Quidel's AmpliVue GAS Assay for detection of Group A Streptococcus from throat swabs in patients with symptoms of pharyngitis, the company announced today.

NEW YORK (GenomeWeb) — Quidel said this week that it will officially unveil two new molecular diagnostic systems at the American Association of Clinical Chemistry annual conference and expo in Chicago next week.

NEW YORK (GenomeWeb) — Quidel said after the close of the market Tuesday that second quarter revenues rose 6 percent to $31.5 million compared to $29.7 million in the second quarter of 2013.

NEW YORK (GenomeWeb) – Wells Fargo Securities today initiated coverage of Cepheid with an Outperform rating, Qiagen with a Market Perform rating, and Quidel also with a Market Perform rating.

Quidel said this week that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct HSV 1+2/VZV multiplex real-time assay.

NEW YORK (GenomeWeb) — Quidel said today after the close of the market that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct HSV 1+2/VZV multiplex real-time assay.

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