Qiagen Wins FDA Clearance for QIAstat-Dx Syndromic Testing System, Respiratory Panel

Qiagen Wins FDA Clearance for QIAstat-Dx Syndromic Testing System, Respiratory Panel
Qiagen has launched its QIAstat-Dx Syndromic Testing System (pictured) along with the multiplex QIAstat-Dx Respiratory Panel after receiving FDA 510(k) clearances. [Qiagen]

Qiagen said today it has launched its QIAstat-Dx syndromic testing system along with the multiplex QIAstat-Dx respiratory panel after receiving FDA 510(k) clearances.

QIAstat-Dx (formerly STAT-Dx DiagCORE) is a next-generation multiplex molecular diagnostic system designed to enable fast, cost-effective and flexible syndromic testing with novel “Sample to Insight” solutions applying real-time PCR technology and Qiagen chemistries.

Based on proprietary DiagCORE technology, QIAstat-Dx has what the company termed a “significant” installed base of users. The system received CE-IVD marking in January 2018—the same month Qiagen announced its up-to-$191 million acquisition of the technology and its original developer, STAT-Dx of Barcelona, Spain.

Qiagen agreed to pay $147 million cash upfront, and up to an additional $44 million through 2022 tied to achieving regulatory and commercial milestones, in a deal completed in April 2018—the month that QIAstat-Dx was launched in Europe

“DiagCORE has been enthusiastically received in Europe and other regions of the world for its rapid, clear insights in clinics and other near-patient settings, as well as its cost-efficiency. We now look forward with the launch of QIAstat-Dx to similar success in the U.S.,” Thierry Bernard, Senior Vice President and Head of Molecular Diagnostics for Qiagen, said in a statement.

QIAstat-Dx is being launched with a respiratory panel designed to detect more than 20 pathogens—the first in a pipeline of planned assays for the syndromic testing system in the U.S., with plans to launch a gastrointestinal panel later in 2019.

48-Target Pipeline Planned

Qiagen said the planned pipeline will have the ability to multiplex as high as 48 targets, spanning infectious diseases, oncology, companion diagnostics, and other disease areas.

QIAstat-Dx Respiratory Panel is a multiplexed nucleic acid test designed to evaluate nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections.

The panel is capable of identifying the following pathogens and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussisChlamydophila pneumoniae and Mycoplasma pneumoniae.

The company cited growing demand for syndromic testing with molecular diagnostics, as users seek to more accurately assess infections and other diseases that first manifest as a set of symptoms with uncertain causes.

According to estimates by the U.S. Centers for Disease Control (CDC), the nation saw about 49 million influenza cases in 2017-2018, leading to 960,000 hospitalizations and 79,000 deaths. CDC uses estimates of flu cases because most respiratory infections are not diagnosed or reported with precision as part of the agency’s disease surveillance system.

Qiagen has forecasted a total addressable market at about 1.5 million tests per year in the U.S. for flu syndromes and respiratory syndromes. In its annual report for 2018, Qiagen said the size of that addressable marked was am estimated $800 million.

“We are pleased to roll out the QIAstat-Dx Respiratory Panel for healthcare providers as they begin to prepare for the 2019-20 flu season,” Bernard added.

Among selling points cited by Qiagen for QIAstat-Dx are ease of use, lower cost compared to other systems, flexibility, and speed: According to Qiagen, the system can operate in a range of near-patient clinical setting, eliminating time spent sending samples to a centralized laboratory, with results available in about one hour.

QIAGEN plans to demonstrate the QIAstat-Dx system at the American Society of Microbiology (ASM) Microbe meeting, set for June 20-24 in San Francisco; and the 71st Association of Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo, set for August 4-8 in Anaheim, CA.