In This Article:
QIAGEN N.V. QGEN has secured FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, bolstering its syndromic testing portfolio in the United States. This marks the company’s second FDA clearance of a QIAstat-Dx panel in 2025, building on the authorization of five panels for use on the QIAstat-Dx system in the last 10 months.
With the latest development, QIAGEN now has regulatory clearances for three mini panels for the detection of respiratory and gastrointestinal conditions. These panels are designed for fast and informed treatment decisions in outpatient settings.
QGEN Stock’s Likely Trend Following the News
Following the announcement yesterday, shares of QIAGEN jumped 3.4% to finish the session at $39.88. The Netherlands-based company is the first to offer both comprehensive and targeted syndromic gastrointestinal panels, allowing laboratories to tailor testing to their specific requirements. The panels address the distinct diagnostic needs of both inpatient and outpatient care while addressing a growing demand for flexible testing options that can address healthcare reimbursement challenges. As a result, we expect the new regulatory milestone to positively boost the market sentiment toward QGEN stock.
QIAGEN has a market capitalization of $8.55 billion. The company’s earnings yield of 5.8% compares favorably to the industry average of -32.8% yield. In the trailing four quarters, it delivered an average earnings surprise of 3.6%.
Importance of QGEN’s New Panel and Future Expansion Plans
The newly authorized panel focuses solely on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella and Yersinia enterocolitica – all recognized by the Infectious Diseases Society of America (“IDSA”) as leading causes of gastrointestinal illness. It complements the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral) that covers Campylobacter, Salmonella, Shiga-like toxin-producing STEC, Shigella and Norovirus.
Image Source: Zacks Investment Research
The QIAstat-Dx Gastrointestinal Panel 2 Mini B uses the real-time PCR technology on the company’s QIAstat-Dx system, delivering results in about one hour and with less than one minute of hands-on time. Cycle threshold (Ct) values and amplification curves provide laboratories with additional information in the context of co-infections, and are instantly viewable on the instrument touchscreen with no additional software required.
The QIAstat-Dx system is currently available in more than 100 countries, with over 4,600 instruments placed worldwide through the end of 2024. QIAGEN plans to further expand its QIAstat-Dx portfolio and recently submitted the QIAstat-Dx Rise, a higher-capacity instrument designed to process up to 160 tests per day, for U.S. regulatory clearance.