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Quidel

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.

Roche said this week that the US Food and Drug Administration has approved Roche's Cobas HPV test for use as a first-line primary screening test for cervical cancer in women 25 years and older.

NEW YORK (GenomeWeb) — Quidel said after the close of the market Wednesday that first quarter revenues fell 26 percent to $46.7 million from $62.7 million in Q1 2013.

NEW YORK (GenomeWeb) — Quidel said today that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct Strep multiplex real-time PCR assay.

Quidel said last week that it has received 510(k) clearance from the US Food and Drug Administration for its AmpliVue HSV 1+2 assay for the differentiation of herpes simplex viruses 1 and 2.

NEW YORK (GenomeWeb News) – Quidel announced after the close of the market on Thursday the 510(k) clearance by the US Food and Drug Administration of the company's AmpliVue HSV 1+2 Assay for differentiating and detecting herpes simplex viruses 1 and 2.

Packaging isothermal PCR reagents in blisters and using lateral flow detection, researchers at Boston University hope to develop a low-cost, disposable assay for Bordetella pertussis, the causative agent of whooping cough.

NEW YORK (GenomeWeb News) – Quidel reported after the close of the market on Tuesday that its fourth quarter revenues declined 7 percent year over year on slower influenza and respiratory disease business.

NEW YORK (GenomeWeb News) – UK diagnostics firm Lab21 today announced an expansion of a distribution agreement with Quidel to include AnDiaTec's real-time PCR tests in the UK.

NEW YORK (GenomeWeb News) – Quidel announced that for full-year 2013 it anticipates reporting $175 million in revenues.
That would represent a 12 percent bump up from $155.7 million recorded in 2012 and would beat the average analyst estimate of $174.0 million.

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A new analysis suggests warming, not the arrival of humans, led to the extinction of the woolly rhinoceros thousands of years ago, the Economist reports.

Chinese health officials uncovered SARS-CoV-2 viral RNA on imported frozen food, but the New York Times reports catching COVID-19 that way would be unlikely.

The UK has ordered 60 million coronavirus vaccine doses from Novavax and 30 million doses from Janssen, according to the Guardian.

In Science this week: machine learning model predicts whether ion channel mutations will cause disease, and more.