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 delivers results in 10 minutes, can now be used in home and medical facility settings with CLIA certificates of waiver.
The QuickVue COVID-19 test is approved for individuals aged 14 or older for self-testing and for those aged two and older when administered by an adult. The test is intended for use within six days of symptom onset. If an initial test result is negative, re-testing is required between 48 and 72 hours later with an antigen or molecular test for SARS-CoV-2.
In related news, QuidelOrtho secured FDA 510(k) clearance in December 2023 for its Savanna PCR platform and the accompanying Savanna HSV 1+2/VZV PCR assay, allowing the marketing and sale of these products to U.S. laboratories conducting moderate or high complexity diagnostic testing.
However, the company has withdrawn its FDA 510(k) submission for the Savanna RVP4+ assay after the final dataset did not meet expectations. QuidelOrtho is now focusing on developing a next-generation multiplex assay, expected to be available during the 2024/2025 respiratory season.
QuidelOrtho is also progressing with a sexually transmitted infection (STI) panel and anticipates starting clinical trials later in the second quarter.
This news comes as part of QuidelOrtho's broader efforts to expand its diagnostic offerings and enhance its competitive edge in the market.
The information for this article is based on a press release statement from QuidelOrtho Corporation.
InvestingPro Insights
QuidelOrtho Corporation (NASDAQ: QDEL), known for its diagnostic products such as the QuickVue COVID-19 test, is navigating a challenging market. The company's market capitalization stands at $3.14 billion, reflecting investor sentiment and the company’s position within the diagnostics industry. Despite recent FDA clearances boosting its product lineup, QuidelOrtho's share price has experienced volatility, with a 3-month price total return showing a significant decline of -37.11%. This may suggest market uncertainty about the company's near-term prospects.
From a financial perspective, QuidelOrtho's revenue for the last twelve months as of Q4 2023 was $2.997 billion, with a notable gross profit margin of 49.85%. However, the company has faced a decline in revenue growth over the same period, down by -8.21%. This decline is further accentuated on a quarterly basis, with revenue growth contracting by -14.3% in Q4 2023. These figures provide context to the company's financial health and its operational challenges amidst a dynamic healthcare landscape.
InvestingPro Tips highlight a mixed outlook for QuidelOrtho. On the positive side, the company is expected to become profitable this year, which can be a key driver for future growth. However, it's worth noting that two analysts have revised their earnings expectations downwards for the upcoming period, and the company has not been profitable over the last twelve months. Additionally, QuidelOrtho does not pay a dividend, which may influence investment decisions for income-focused shareholders.
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