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FDA grants Qiagen 510(k) clearance for syndromic testing system

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Thierry Bernard

Qiagen announced it has received 510(k) clearance from the FDA for a multiplex syndromic testing system.

The system, called the QIAstat-Dx, will launch in the United States with a respiratory panel that will allow providers to test for more than 20 viral and bacterial respiratory pathogens.

The QIAstat system is based on Qiagen’s DiagCORE technology and has been available in Europe since 2018, the company said.

“Qiagen’s QIAstat-Dx turns samples into valuable, actionable insights by identifying the exact cause of a patient’s syndrome in as little as an hour, whereas traditional testing can take up to 2 weeks,” Thierry Bernard, senior vice president and head of molecular diagnostics for Qiagen, told Infectious Disease News.

“It delivers the precision of molecular testing to identify hard-to-diagnose respiratory infections, which sicken millions of patients each year and kill tens of thousands. Currently, QIAstat-Dx can be used to detect more than 20 causes of respiratory infections including various types of the flu, coronavirus, rhinovirus, pertussis and pneumonia.”

Bernard noted that the information gathered by the test can determine factors including whether a patient needs an antibiotic vs. an antiviral, whether a patient needs to be isolated and whether a potential outbreak is possible.

“Low plex testing — usually three pathogens — is available for around $40. QIAstat-Dx provides clinicians with more than 20 pathogens for screening and added value information like Ct values and amplification curves for just a little more than $100,” Bernard said. “Cost-efficiency is further driven by a proven decrease of patient length-of-stay in hospitals or increased precision of adapted anti-biotherapy.”

The respiratory panel is the first in a series of planned assays for QIAstat-Dx in the U.S. Additional panels will test for gastrointestinal conditions and meningitis, according to Bernard. – by Joe Gramigna

Disclosure: Bernard is employed by Qiagen.