This section highlights FDA-related milestones and regulatory updates for drugs developed by Qiagen (QGEN).
Over the past two years, Qiagen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
QIAstat-Dx and Cabozantinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
QIAstat-Dx FDA Regulatory Timeline and Events
QIAstat-Dx is a drug developed by Qiagen for the following indication: Respiratory syndromic testing panel.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- QIAstat-Dx
- Announced Date:
- March 10, 2026
- Indication:
- Respiratory syndromic testing panel
Announcement
QIAGEN N.V nnounced that the U.S. Food and Drug Administration (FDA) has cleared the use of all QIAstat-Dx® Gastrointestinal (GI) Panels on the QIAstat-Dx Rise automated syndromic testing system.
AI Summary
QIAGEN announced that the U.S. Food and Drug Administration has cleared the use of all QIAstat-Dx® Gastrointestinal (GI) Panels on the QIAstat-Dx Rise automated syndromic testing system. This clearance lets laboratories run both QIAstat-Dx Respiratory and GI panels on the same high-throughput platform. The panels support syndromic testing—detecting multiple pathogens that cause similar symptoms in a single run—and also offer targeted Mini panels for focused testing.
QIAstat-Dx Rise is designed to increase automation and capacity with a smart drawer that automates cartridge loading and unloading, reducing manual handling and increasing walkaway time. With up to eight analytical modules, the system can process as many as 160 tests per day, run 16 samples per batch, and keep urgent slots for priority samples to support faster clinical decisions. QIAstat-Dx systems are available in more than 100 countries, with over 5,200 instruments placed worldwide.
Read Announcement- Drug:
- QIAstat-Dx
- Announced Date:
- March 6, 2025
- Indication:
- Respiratory syndromic testing panel
Announcement
QIAGEN announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.
AI Summary
QIAGEN announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use. This new panel is designed to deliver rapid detection of five common bacterial pathogens that frequently cause gastrointestinal infections, such as Campylobacter, Salmonella, STEC, Shigella, and Yersinia enterocolitica. Tailored for outpatient settings, the panel helps healthcare providers make swift and informed treatment decisions. It uses real-time PCR technology to multiply specific genetic targets, generating results in about one hour with less than one minute of hands-on time. The FDA clearance further strengthens QIAGEN’s portfolio in syndromic testing within the United States by offering a targeted solution aimed at efficiently diagnosing bacterial gastrointestinal infections, ultimately supporting laboratories and clinicians in optimizing diagnostic workflows and patient care.
Read Announcement- Drug:
- QIAstat-Dx
- Announced Date:
- June 3, 2024
- Indication:
- Respiratory syndromic testing panel
Announcement
QIAGEN announced the launch of the QIAstat-Dx Gastrointestinal Panel 2 in the United States.
AI Summary
QIAGEN recently launched the QIAstat-Dx Gastrointestinal Panel 2 in the United States. This new panel, which received FDA clearance for clinical use, tests for up to 16 different bacterial, viral, and parasitic pathogens that cause gastrointestinal infections. The test uses real-time PCR technology to deliver results in about one hour—a significant improvement over traditional methods that may take from 24 hours to several days.
The new panel provides cycle threshold (Ct) values and amplification curves, offering clear insights into positive or negative results for each pathogen. This quick and accurate diagnosis helps healthcare providers identify the specific GI pathogen involved and decide the best treatment plan for patients. Additionally, it simplifies workflow in clinical settings by coming in a single-use cartridge that fits easily into the QIAstat-Dx Analyzer, making the testing process efficient and reliable.
Read Announcement
Cabozantinib (CABOMETYX) FDA Regulatory Events
Cabozantinib (CABOMETYX) is a drug developed by Qiagen for the following indication: Differentiated thyroid cancer (DTC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cabozantinib (CABOMETYX)
- Announced Date:
- January 9, 2025
- Indication:
- Differentiated thyroid cancer (DTC)
Announcement
QIAGEN announced a significant increase in the powerful capabilities of its QIAcuity Digital PCR (dPCR) system with a more than two-fold increase in the number of targets that can be simultaneously analyzed from a single biological sample.
AI Summary
QIAGEN announced a significant upgrade to its QIAcuity Digital PCR system. With the new QIAcuity Software 3.1 and the High Multiplex Probe PCR Kit, the system can now analyze up to 12 targets simultaneously from a single biological sample – a more than two-fold increase from the previous capability of five targets. This improvement boosts the system’s effectiveness in detecting DNA and RNA signals, streamlining research workflows. Researchers benefit by saving time, reagents, and valuable sample material while obtaining deeper biological insights. The enhanced multiplexing capacity overcomes many assay design challenges and is ideal for complex studies, including microbiome analysis, pathogen detection, translational research, and cell and gene therapy development. Best of all, these upgrades require no hardware changes, allowing current QIAcuity users to immediately enjoy improved capabilities in their laboratory work.
Read Announcement
