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Dx Focus: Quidel, OpGen, Curetis, Luminex


Quidel said this week that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct HSV 1+2/VZV multiplex real-time assay.

Quidel's assay detects and differentiates herpes simplex viruses 1 and 2 and varicella-zoster virus nucleic acids isolated and purified from swab specimens taken from cutaneous or mucocutaneous lesions on symptomatic patients.

HSV 1 is the virus responsible for most cold sores and some genital herpes transmissions, while HSV 2 is primarily responsible for most genital herpes and some cold sores. Meantime, VZV is responsible for chicken pox in children and shingles in adults.

The test is part of Quidel's portfolio of Lyra brand ready-to-use PCR reagent kits designed to be compatible with a laboratory's existing thermal cycler. According to Quidel, these kits feature a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents.

Quidel also offers FDA-cleared molecular diagnostic assays under the Lyra brand for infectious diseases such influenza A and B, respiratory syncytial virus, human metapneumovirus, Clostridium difficile, and Group A and pyogenic Group C or G Streptococcus.


OpGen has launched a molecular test to identify patients at risk for harboring serious disease-causing and antibiotic-resistant organisms, the company said this week.

The new Acuitas MDRO Gene Test is a comprehensive screening tool that can detect as many as seven genes from one patient sample, and is designed to help hospitals and public health officials combat some of the most critical multi-drug-resistant organisms threatening patients, OpGen said.

Performed in OpGen's CLIA-certified clinical services laboratory in Gaithersburg, Md., the assay uses DNA amplification and detects genes from bacteria such as carbapenem-resistant enterobacteriaceae containing KPC, NDM-1, and OXA-48 genes. These bacteria are resistant to nearly all antibiotics such as carbapenems, a broad spectrum class of antibiotics considered to be the last resort for serious gram-negative bacterial infections, the company said.

Unlike current microbe detection methods based on growing cells in laboratory culture — which can take up to four days and miss patients at risk for being colonized — Acuitas uses highly sensitive molecular technology to detect antibiotic resistant genes within 24 hours, according to OpGen.

"The strength of this technology is based on the more accurate genomic approach to the detection of highly transmissible genes as opposed to traditional bacterial culture," James Snyder, professor of pathology and laboratory medicine at the University of Louisville School of Medicine, said in a statement. "In addition, it can help to identify those patients who harbor MDROs, which may increase their risk for infection."

OpGen said that it plans to share additional details about the Acuitas MDRO Gene Test at the American Society of Microbiology annual meeting next week in Boston.


German molecular diagnostics developer Curetis said this week that Robin Patel, professor of medicine and microbiology at the Mayo Clinic in Rochester, Minn., has been named lead principal investigator of the clinical trial to gain clearance for the company’s Unyvero LRT test.

Patel, who chairs the Division of Clinical Microbiology and Mayo Clinic's Bacteriology Laboratory and directs the Infectious Diseases Research Laboratory, is a specialist in the clinical detection and identification of bacteria, including the characterization of their antimicrobial resistance and susceptibility, particularly for biofilm-mediated infections.

She succeeds Christine Ginocchio, formerly of North Shore-LIJ Health System Laboratories, who recently left North Shore-LIJ to assume a corporate position in the microbiology field, Curetis said.

Curetis' LRT (lower respiratory tract) application is designed to detect 17 pathogens and 22 antibiotic resistance gene markers of clinical importance in patients with suspected LRT infections.

To bolster enrollment and to capture potential geographical differences in pathogen and antibiotic resistance gene distribution, Curetis also announced the addition of six new clinical trial sites in the last few quarters, expanding its clinical trial network to nine testing sites.


Luminex said this week that Group B Streptococcus (GBS) is the fifth assay planned for the launch menu of its forthcoming sample-to-answer molecular testing system, Aries.

Previously announced items in the five-assay launch menu include influenza A/B and respiratory syncytial virus; herpes simplex viruses 1 & 2, norovirus, and Clostridium difficile.

"Early detection of group B strep in pregnant women is important to prevent serious disease in infants," Luminex CEO Patrick Balthrop said in a statement. "Our expanding menu of assays, universal protocol, and flexible random batch capability provide unmatched ease of use and versatility for today's laboratories."