SAN DIEGO – QuidelOrtho Corporation (NASDAQ: QDEL), a leading diagnostics company, has received FDA 510(k) clearance for its QuickVue COVID-19 test, designed for symptomatic individuals. The test, which provides results in 10 minutes, can now be used at home and in medical facilities with CLIA exemption certificates.
The QuickVue COVID-19 Test is approved for individuals aged 14 years and older for self-testing and for those aged two years and older when administered by an adult. The test must be used within six days of the onset of symptoms. If your initial test result is negative, you should retest within 48 to 72 hours with an antigen or molecular test for SARS-CoV-2.
In other news, QuidelOrtho received FDA 510(k) clearance in December 2023 for its Savanna PCR platform and the accompanying Savanna HSV 1+2/VZV PCR assay, enabling the commercialization and sale of these products to US laboratories that perform diagnostic tests of moderate or high complexity.
However, the company withdrew its application for FDA 510(k) clearance for the Savanna RVP4+ test after the final data set did not meet expectations. QuidelOrtho is now focusing on the development of a next-generation multiplex test, which is expected to be available during the 2024/2025 respiratory season.
QuidelOrtho is also moving forward with a panel for sexually transmitted infections (STIs) and expects to begin clinical trials during the second quarter.
This news is part of QuidelOrtho’s broader efforts to expand its diagnostic offerings and improve its competitive advantage in the market.
The information in this article is based on a press release from QuidelOrtho Corporation.
Insights from InvestingPro
QuidelOrtho Corporation (NASDAQ: QDEL), known for its diagnostic products like the QuickVue COVID-19 test, is going through a tough market. The company’s market capitalization is $3.14 billion, reflecting investor sentiment and the company’s position in the diagnostics industry. Despite recent FDA clearances that have boosted the product line, QuidelOrtho’s share price has seen some volatility, with the three-month total return showing a significant decline of -37.11%. This could suggest market uncertainty about the company’s near-term prospects.
From a financial perspective, QuidelOrtho’s revenue over the trailing twelve months, as of Q4 2023, was $2.997 billion, with an impressive gross profit margin of 49.85%. However, the company faced a decline in revenue growth of -8.21% during the same period. This decline is further accentuated on a quarterly basis, with a revenue contraction of -14.3% in the fourth quarter of 2023. This data provides insight into the company’s financial health and operational challenges in a dynamic healthcare landscape.
InvestingPro’s recommendations highlight mixed prospects for QuidelOrtho. On the bright side, the company is expected to become profitable this year, which can be a key driver for future growth. However, it is worth noting that two analysts have revised down their earnings expectations for the coming period, and that the company was not profitable in the last twelve months. Additionally, QuidelOrtho does not pay a dividend, which could influence the investment decisions of income-minded shareholders.
For readers looking to delve deeper into QuidelOrtho’s financials and future prospects, InvestingPro offers additional insights and metrics. There are currently 6 more InvestingPro recommendations for QuidelOrtho available at https://www.investing.com/pro/QDEL. These tips can provide valuable guidance to investors considering QuidelOrtho as part of their investment portfolio. Use the coupon code PRONEWS24 to get an additional 10% discount on an annual or two-year subscription to Pro and Pro+, giving you comprehensive analysis that could inform your investment decisions.
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