This is a companion article to the feature, “Targeting Antibiotic Resistance.”

By Shara Rosen

IVD manufacturers have become very active in developing tests to detect the presence of antibiotic-resistant pathogens, wherever they may appear. Below, roughly in company order, is a short selection of some of the advances made in antibiotic resistance testing over the past few years.

Alere received the first CLIA waiver for a nucleic acid-based flu diagnostic test—the Alere i influenza A and B test—permitting it to be used in a wider variety of healthcare settings.

Aperiomics is developing a system combining high-throughput next-generation sequencing and advanced Bayesian statistics to produce faster and more accurate results than culture-based or even other molecular-based diagnostic approaches. From a single test, the company’s technology can simultaneously test for bacteria, viruses, fungi, or parasites. The sample can be tissue, blood, plant, animal, or environmental.

The FilmArray platform by BioFire Diagnostics, a subsidiary of bioMérieux, offers an easy-to-use multiplex PCR system with FDA-cleared panels for blood culture identification, respiratory infections, and gastrointestinal infections. It can also detect common resistance patterns.

Cepheid, the Foundation for Innovative New Diagnostics, and Rutgers New Jersey Medical School are codeveloping Xpert MTB/RIF Ultra, a next-generation test for tuberculosis (TB) with increased sensitivity to aid in detecting patients with smear-negative TB.

The Critical Path Institute has received a multiyear grant from the Bill & Melinda Gates Foundation to fund the creation and implementation of a rapid drug susceptibility test data platform. The platform will catalog a vast amount of genomic data about tuberculosis strains worldwide. The database will inform correlations between mutations and clinically relevant resistance.

In 2014, Great Basin Scientific announced it had initiated a clinical trial for its sample-to-result staph identification/resistance diagnostic test.

Greiner Bio-One Genspeed MRSA_500

The Genspeed test kit for rapid detection of methicillin-resistant Staphylococcus aureus, by Greiner Bio-One.

Greiner Bio-One has developed the Genspeed test system for rapid detection of methicillin-resistant Staphylococcus aureus (MRSA). The test provides qualitative detection of MRSA within 75 minutes from human nasal and pharyngeal smears, targeting both resistance genes mecA and mecC.

Hain Lifescience GmbH has developed the GenoType MTBDRsl, a rapid molecular test that detects resistance to second-line fluoroquinolone drugs and second-line injectable drugs as well as detecting multidrug resistant tuberculosis.

Mass spectrometry (MS) is contributing to antibiotic resistance testing with MS-based microbiology systems from a variety of IVD companies, including Abbott Diagnostics, Becton Dickinson, bioMérieux, Bio-Rad Laboratories, Bruker Biosciences, Siemens Healthcare Diagnostics, and Thermo Fisher. MS tests reduce turnaround time for organism identification from days to hours, improving the options for therapeutic decision-making.

Mobidiag has developed a microarray-based assay, Prove-It Bone & Joint Assay, to detect more than 60 of the most common Gram-positive and Gram-negative bacterial species, including detection of mecA, vanA, and vanB resistance genes directly from osteoarticular samples.

Gene-Radar by Nanobiosym employs a nano-biophysics approach to provide a portable nanotechnology platform that can rapidly detect a genetic fingerprint from any biological organism, anywhere. The resulting DNA/RNA signature identifies the pathogen and its drug-resistance profile.

Shara Rosen is a contributing writer for CLP. For more information, contact CLP chief editor Steve Halasey via [email protected].