QuidelOrtho Expands Portfolio With the Launch of FDA-Approved Test

Last week, QuidelOrtho Corporation QDEL announced the availability of QUICKVUE Influenza + SARS Test. The CLIA-waived, 510(k)–cleared rapid, easy-to-use immunoassay is the latest addition to the company’s QUICKVUE portfolio and has been designed for professional use in physician office laboratories, urgent care centers, emergency departments, pharmacies and decentralized hospital labs.The latest launch of the QUICKVUE Influenza + SARS Test expands QuidelOrtho's portfolio of respiratory solutions and is currently available in the United States through its existing distribution channels. However, the test is not intended for in-home use.The latest addition and subsequent expansion of QuidelOrtho's portfolio are expected to significantly boost its Molecular Diagnostics and Point of Care business units and strengthen its foothold in the niche space across the nation.Significance of QDEL’s Product LaunchPer QuidelOrtho, the QUICKVUE Influenza + SARS Test is expected to deliver rapid, simultaneous detection and differentiation of influenza A, influenza B and SARS-CoV-2 antigens from a single patient sample and provide results within 10 minutes. Management believes that this capability will likely aid clinicians in distinguishing between COVID-19 and seasonal flu infections, which present similar symptoms, enabling timely treatment decisions and improved patient outcomes.Industry Prospects in Favor of QuidelOrthoPer a report by Grand View Research, the global point-of-care diagnostics market was estimated at $47.8 billion in 2024 and is anticipated to reach $68.5 billion by 2030 at a CAGR of 5.8%. Factors like the ability of point-of-care diagnostic tests to provide immediate results and technological advancements are likely to drive the market.Given the market potential, the latest launch is expected to provide a significant boost to QuidelOrtho’s business.QDEL’s Notable DevelopmentIn August, QuidelOrtho reported its second-quarter 2025 results, wherein its Molecular Diagnostics revenues recorded robust growth on both a reported basis and at constant exchange rate (CER).Comparison With PeersA notable peer of QuidelOrtho is Qiagen N.V. QGEN. This month, Qiagen received CE-IVDR certification for its full portfolio of QIAstat-Dx syndromic testing systems and panels, including an expanded Meningitis/Encephalitis Panel. The QIAstat-Dx system now offers CE-IVDR certified panels for respiratory, gastrointestinal and central nervous system infections that help clinicians diagnose infectious diseases with greater speed and accuracy. The same month, Qiagen announced the launch of QIAstat Dx Rise – a version of the QIAstat-Dx automated syndromic testing system.Another notable player in the Molecular Diagnostics space and peer of QuidelOrtho is Hologic, Inc. HOLX. In July, Hologic announced its third-quarter fiscal 2025 results, wherein it recorded a robust uptick in Diagnostics revenues both on a reported basis and at CER. This was primarily driven by Hologic’s higher molecular diagnostics sales, whose revenues were also solid on a reported basis and at CER on the back of higher sales of its BV CV/TV and Panther Fusion assays. Excluding COVID-19 revenues, Hologic’s molecular diagnostics revenues were also robust both on a reported basis and at CER.QuidelOrtho’s peer and another notable name in the Diagnostics space is Thermo Fisher Scientific Inc. TMO. In July, Thermo Fisher reported its second-quarter 2025 results, wherein its Specialty Diagnostics revenues witnessed strength. The same month, Thermo Fisher debuted two new solutions, LabLink360 and Thermo Scientific MAS Max quality controls, designed to support quality control assurance and streamline workflows in clinical laboratories, at the Association for Diagnostics & Laboratory Medicine Conference.7 Best Stocks for the Next 30 DaysJust released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.5% per year. So be sure to give these hand picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Thermo Fisher Scientific Inc. (TMO): Free Stock Analysis Report Hologic, Inc. (HOLX): Free Stock Analysis Report QIAGEN N.V. (QGEN): Free Stock Analysis Report QuidelOrtho Corporation (QDEL): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks