QIAGEN says FDA cleared second QIAstat‑Dx bloodstream panel

A second bloodstream infection panel received U.S. FDA clearance on Monday as QIAGEN N.V. NYSEQGEN FRAQIA added a gram-negative assay with 13 bacterial targets to its QIAstat-Dx range. The same September 2026 QIAGEN document lists 18 antimicrobial resistance markers for the new test.

QIAGEN described the Sept. 28 clearance as completing its U.S. bloodstream infection portfolio. The company announced FDA clearance for its first QIAstat-Dx bloodstream panel on Aug. 10, making Monday's decision a second regulatory step for the test range.

QIAGEN is a Netherlands-based global supplier of molecular diagnostics and life sciences tools for clinical and research laboratories.

Its New York shares closed at US$44.18 on Sept. 25, according to NYSEQGEN as of 4:00 p.m. EDT. That close preceded the Sept. 28 announcement and cannot measure the market's response to the new clearance.

The Test Starts With A Positive Blood Culture

QIAGEN's blood culture product page describes its first panel as covering gram-positive bacteria and fungi, while the newly cleared assay covers gram-negative bacteria. It says the panels can identify pathogens and selected resistance markers in approximately one hour after a blood culture turns positive.

That timing starts after a laboratory has grown and flagged a blood culture, rather than when blood is first collected from a patient. The new assay identifies organisms and selected genes associated with resistance; it is not a stand-alone screen of an untreated blood sample.

The September safety summary says the gram-negative test works with both versions of the QIAstat-Dx analyzer. Some positive blood culture samples require dilution before they are loaded into the cartridge, a handling step that laboratories would have to account for when adding the panel to their routine.

"The performance of this test has not been established for monitoring response to treatment for any of the panel organisms," QIAGEN says in its September 2026 safety and performance summary.

The same document describes a qualitative result and says the panel is intended for use alongside standard culture and antimicrobial susceptibility testing where applicable. A resistance marker identifies a genetic signal; the test's instructions still direct clinicians to interpret the result alongside other laboratory and clinical findings.

QIAGEN's product page cautions that the gram-negative panel is not available in every country. FDA clearance establishes its U.S. regulatory status, while a first shipment or an order from a U.S. laboratory would provide separate evidence of commercial uptake.

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BioMérieux Lists A Competing Blood Culture Test

bioMérieux SA EPABIM says its BIOFIRE BCID2 panel tests 43 targets associated with bloodstream infections, including 10 antimicrobial resistance genes. Its product page, checked Sept. 28, says results take about one hour from a positive blood culture.

BioMérieux offers those targets on one panel, while QIAGEN's cleared U.S. range uses separate gram-positive and gram-negative panels. The published target counts describe test menus; they do not establish which system performs better in a laboratory or improves a patient's outcome.

BioMérieux shares closed at €77.70 in Paris on Sept. 25, according to EPABIM as of 5:35 p.m. CEST. That sector peer price also predates QIAGEN's announcement, so neither quoted close captures a reaction to Monday's news.

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The Sept. 28 New York close will be the first dated market measure after QIAGEN's release, showing whether shares repriced on the second FDA clearance. Later orders and sales will show whether the expanded test range gains laboratory use.