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.
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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.
Industry Prospects Favor QIAGEN
Per a research report, the global gastrointestinal diagnostics market was valued at $5.1 billion in 2024 and is expected to grow at a compound annual rate of 4.3% through 2030. Major factors driving the growth of this market are the rising demand for point-of-care (POC) testing for gastrointestinal disorders and the increasing incidence of gastric infections and cancers.
Latest Updates Within QGEN
Last month, QIAGEN announced the official opening of a new data center in Melbourne, Australia, to strengthen its global bioinformatics leadership position in this region. The investment supports the expanding data center market in the Australia/Asia-Pacific region while ensuring local compliance and high-quality solutions for Omics analysis and interpretation in genomic testing laboratories.
QGEN Stock Price Performance
In the past three months, QGEN shares have lost 12.5% compared to the industry’s modest 0.7% decline.
QGEN’s Zacks Rank and Key Picks
QIAGEN currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Hims & Hers Health HIMS, Inspira Medical Systems INSP and Cardinal Health CAH. Each of these carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Hims & Hers Health’s 2025 earnings per share have jumped 34.6% to 70 cents in the past 30 days. Shares of the company have surged 186.2% in the past year against the industry’s 11.2% fall. HIMS’ earnings surpassed estimates in two of the trailing four quarters, matched in one and missed on another occasion, the average surprise being 40.4%.
Inspira shares have dipped 2.3% in the past year. Estimates for the company’s 2025 earnings per share have increased 6.4% to $2.16 in the past 30 days. INSP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 332.5%. In the last reported quarter, it posted an earnings surprise of 55.4%.
Estimates for Cardinal Health’s fiscal 2025 earnings per share have increased 14.7% to $7.94 in the past 30 days. Shares of the company have jumped 12.8% in the past year against the industry’s 2.1% fall. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. In the last reported quarter, it delivered an earnings surprise of 10.3%.
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