OpGen Submits Antibiotic Resistance Test to FDA

May 14, 2019

|

NEW YORK (GenomeWeb) — OpGen said today that it has submitted its Acuitas AMR Gene Panel for the detection of antibiotic resistance to the US Food and Drug Administration for 510(k) clearance.

The PCR-based test is designed to detect 47 antibiotic resistance genes in less than three hours from bacterial isolates. It is currently available for research use only.

To read the full story....

...and receive Daily News bulletins.

Already have a 360Dx or GenomeWeb account?
Login Now.

Don't have a 360Dx or GenomeWeb account?
Register for Free.

Featured White Papers

Delivering Precision Health: the Role of Molecular Diagnostics

Type 1 Interferon Gene Expression Analysis: Precision Medicine in Lupus

Jul

23

Featured Webinar

A Novel Quality Improvement Model to Support Molecular Testing of Oncology Patients

This webinar will discuss how the Molecular Pathology Laboratory at the University of Oklahoma (OUMP) is using a new quality improvement model to support molecular testing of oncology patients.

Jul

25

Featured Webinar

Cell-free DNA Testing for Fetal Aneuploidy: Lessons Learned and Implications for Clinical Practice

This webinar will discuss the evolution of fetal aneuploidy screening and the most recent evidence around the implementation of prenatal cell-free DNA testing in clinical practice.

Jul

31

Featured Webinar

Considerations and Impact of Implementing Targeted NGS in Myeloid Malignancies

This webinar will provide a first-hand look at how a molecular laboratory validated and implemented a targeted next-generation sequencing-based myeloid assay to expedite the assessment of myeloid malignancies and assist in the understanding of myeloid cancers.

Menu