Welcome to our dedicated page for Quidel news (Ticker: QDEL), a resource for investors and traders seeking the latest updates and insights on Quidel stock.
QuidelOrtho Corporation reports developments in in vitro diagnostics, including rapid testing, immunoassay and molecular testing, clinical chemistry, transfusion medicine and point-of-care diagnostic platforms. Company updates commonly address financial results, revenue trends, guidance, respiratory testing seasonality, international market conditions and portfolio activity across labs, cardiac, immunohematology and molecular diagnostics.
Recurring news also covers product and technology developments such as the LEX VELO System, a point-of-care molecular PCR platform with FDA 510(k) clearance and CLIA waived status for Flu A, Flu B and COVID-19 testing, as well as diagnostic education topics including syphilis screening and high-sensitivity troponin. Governance and management changes appear alongside business updates and investor conference participation.
Quidel Corporation (NASDAQ: QDEL) announced that it expects revenue for Q4 2020 to be between $808 million and $810 million, a significant increase from $476 million in the previous quarter. This growth is attributed to heightened demand for COVID-19 diagnostic products, with open orders at the end of 2020 representing about 25% of total shipments for the year. Additionally, Quidel plans to significantly scale production from 13 million tests per month to over 70 million by the end of 2021. The company will present more detailed financial results in February 2021.
Quidel Corporation (NASDAQ: QDEL) has received Emergency Use Authorization (EUA) from the FDA for its Solana® SARS-CoV-2 Assay. This isothermal RT-HDA assay allows for qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal and nasal swab specimens. Key advantages include a 25-minute run time for up to 11 samples, no sample extraction, and enhanced laboratory efficiency. The Solana instrument is user-friendly and designed for space efficiency. Quidel aims to meet the increasing demand for COVID-19 testing solutions with this innovative technology.
Quidel Corporation (NASDAQ: QDEL) has received Emergency Use Authorization (EUA) from the FDA for its QuickVue® SARS Antigen test, designed for rapid COVID-19 detection within five days of symptom onset. This test boasts a 96.6% positive and 99.3% negative predictive accuracy compared to PCR tests, providing results in just 10 minutes without the need for instrumentation. Quidel aims for a production rate of 600 million tests annually by end of 2021, enhancing access to affordable testing across diverse healthcare settings.
Quidel Corporation (NASDAQ: QDEL) announced that CEO Douglas Bryant has been named Executive of the Year in the MedTech Dive Awards for 2020. This recognition highlights Bryant's leadership in pivoting the company's focus to COVID-19 diagnostics during the pandemic. Quidel was the first to receive FDA Emergency Use Authorization for rapid antigen testing, achieving a performance rate of 96.7% PPA. The company doubled its production capacity to over two million tests per week and plans to triple it to six million tests thanks to rising demand.
Quidel Corporation (NASDAQ: QDEL) has announced its participation in two upcoming virtual conferences: the Canaccord Genuity Virtual MedTech & Diagnostics Forum on November 19, 2020, and the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 2, 2020. Presentations by CEO Douglas Bryant and CFO Randy Steward will cover business and financial developments. Live webcasts of both events will be available on Quidel's Investor Relations website, with archives accessible for 30 days post-event.
Quidel Corporation has received three prestigious awards from the MarCom Awards competition, recognizing its creative excellence in marketing and communications. Notably, Quidel earned a Platinum Award for its consumer website, “Lyme Disease Answers,” which aims to educate the public about Lyme disease. Additionally, the company won a Gold Award for its upcoming series of educational videos titled “Quick Takes,” aimed at enhancing knowledge among healthcare professionals and consumers. Quidel's Sofia® 2 Lyme FIA test continues to lead in rapid Lyme disease testing, providing quick results to facilitate timely treatment.
Quidel Corporation (NASDAQ:QDEL) will host its Investor Day 2020 virtually on November 12, 2020, starting at 8:00 a.m. PT. The event will feature a management presentation followed by a Q&A session, where the company will discuss key business and financial developments.
To participate, register at Quidel's Investor Relations page or via the presentation link. A live webcast and replay will be available on the company's website for 90 days.
Quidel Corporation (NASDAQ: QDEL) will announce its third fiscal quarter 2020 financial results after market close on October 29, 2020. CEO Douglas Bryant and CFO Randy Steward will host a conference call at 5:00 p.m. ET to discuss these results and address investor questions. The live call will be accessible by phone or webcast, with a replay available for one year on the website and for 14 days via telephone. Quidel focuses on rapid diagnostic testing and aims to enhance healthcare outcomes globally.
Quidel Corporation (NASDAQ: QDEL) has received Emergency Use Authorization (EUA) from the FDA for its Sofia® 2 Flu + SARS Antigen FIA, a rapid test for detecting SARS-CoV-2 and influenza viruses. This single test provides results in just 15 minutes from a nasal swab, promoting timely and accurate diagnosis. Quidel's test shows a 95.2% positive predictive accuracy for SARS-CoV-2 and significant sensitivity for influenza strains, addressing the challenge of overlapping symptoms during flu season. The company aims to enhance diagnostic speed and accuracy in healthcare settings.
Quidel Corporation (NASDAQ: QDEL) announced anticipated third-quarter revenues ranging from $475 million to $477 million, driven by increased demand for COVID-19 diagnostic products. The CEO highlighted the company’s role in enhancing testing accessibility and expects revenues to exceed $800 million in the last quarter of 2020. A virtual Investor Day is scheduled for November 12, 2020, where management will discuss significant business developments. Full financial results will be released in late October 2020.