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December 1, 2021

FDA grants 510(k) clearance for Immunexpress’ SeptiCyte RAPID test

SeptiCyte RAPID is performed on Biocartis’ PCR-based molecular testing system, the Idylla platform.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the fully automated SeptiCyte RAPID test from Immunexpress.

Developed in collaboration with Biocartis Group, the test distinguishes sepsis from non-infectious systemic inflammation in patients who are suspected of having sepsis.

The test is performed on Biocartis’ easy-to-use, polymerase chain reaction (PCR)-based molecular testing system, the Idylla platform.

It comprises all the reagents which are required to quantify gene expression with the help of a reverse transcription (RT)-PCR to determine the host response genes’ relative expression levels from whole blood.

The fully automated test provides results in approximately one hour and allows physicians to optimise their patient management decisions.

Immunexpress chief medical officer Roy Davis said: “SeptiCyte RAPID has the potential to transform sepsis diagnosis, addressing a critically unmet need in the ICU.

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“SeptiCyte RAPID has been evaluated in hospitals since 2019. Major hospital systems with which we have worked are anxiously waiting to incorporate this into the current diagnostic toolset, allowing clinicians to make swift and accurate clinical decisions, ultimately improving patient outcomes.”

The company stated that the regulatory approval was based on data obtained from retrospective and prospective studies which assessed the SeptiCyte RAPID’s clinical accuracy.

The NEar PatienT MolecUlar TestiNg in SEpsis (NEPTUNE) prospective study assessed the test’s real-time performance in a clinical setting at Emory University in Georgia, the University of Southern California and Rush University in Chicago.

Meanwhile, the retrospective clinical study included eight centres in Europe and the US from the VENUS clinical trial (NCT02127502) and MARS clinical trial (NCT01905033).

Furthermore, Immunexpress plans to commercialise the SeptiCyte RAPID test across the US next year.

In March, Biocartis introduced its Idylla GeneFusion Assay as a rapid lab workflow solution for gene fusion testing.

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