Pandemic Response Lab (PRL), a wholly owned subsidiary of Opentrons Labworks, Inc., announced two new three-target monkeypox tests, each developed and performed by its New York and Maryland laboratories, respectively. These skin lesion tests qualitatively detect three different viral genome targets of increasing specificity: non-variola orthopoxvirus, monkeypox virus species and monkeypox virus clade II. Use of these three viral targets identified by the Centers for Disease Control and Prevention (CDC) enhances the ability to detect mutant monkeypox virus strains.
The outbreak and spread of the monkeypox virus was declared a public health emergency by the World Health Organization and by the U.S. Department of Health and Human Services in August 2022, when more than 25,000 cases had been identified across all 50 states and Washington, D.C. These U.S. infections make up more than one-third of all cases globally. Currently, only a handful of commercial laboratories have authorization to offer one of the CDC tests that targets a single location in the virus genome common to all non-variola orthopoxvirus.
PRL’s offerings add increased diagnostic capacity and accessibility nationwide and improve upon the typical two-to-four-day turnaround time, delivering results to physicians and patients much faster, in less than 24 hours after sample receipt. Additionally, the use of multiplex real-time polymerase chain reaction to simultaneously detect viral DNA sequences unique to the genus, the species and the clade safeguards against mutations that could potentially render single-target tests unable to detect mutant substrains.
“PRL’s market leading molecular testing automation expertise benefits healthcare systems, clinicians and patients by providing affordable, quick turnaround testing to prevent further transmission of viruses and infections,” said PRL’s General Manager of Laboratory Services, Nick Mitilenes. “Our multi-target monkeypox tests include confirmatory results rather than presumptive positive results and do not need additional confirmatory testing.”
The monkeypox tests further strengthen PRL’s leadership in the diagnostic testing industry and its proven ability to provide fast-turnaround infectious disease test results to address current clinical diagnostic and public health challenges. PRL has been a leader in the COVID-19 response by making affordable molecular SARS-CoV-2 testing accessible on a public health scale. Its monkeypox tests follow the recent introduction of its respiratory and sexually transmitted infection test panels, marking another step toward expanding PRL’s diagnostic services beyond COVID-19 into other infectious disease areas.
PRL’s Monkeypox (NVO, MPXV Clade II, MPXV) DNA, NAA PCR, swab tests are available in its Long Island City, New York and Rockville, Maryland CLIA-certified laboratories. Tests run in each PRL laboratory are independently developed and validated at their respective facility.