CUUR Diagnostics was founded by experienced medical scientists and healthcare professionals and utilize industry leading equipment including Thermofisher, under CAP and CLIA quality standards, to rapidly deliver high complexity qPCR molecular testing for infectious disease identification. The CUUR Diagnostics’ SARS-COV-2 assay is an Emergency Use Authorization (EUA) test awarded by the U.S. FDA.
CUUR Diagnostics is a division of Assurity Healthcare, and is a Medicare-certified clinical laboratory provider that offers innovative healthcare laboratory solutions to hospitals, clinics and other medical entities. Serving clients across multiple states in the U.S., our services include infectious disease testing, planning, build-out, staffing, compliance and operation of complex medical labs.
Our solutions are based on three key pillars:
- Innovation through research and development
- Quality though analysis, education and training
- Long-term success through service excellence
The recent spread of COVID-19 as a Pandemic, decades of antibiotic overuse, skyrocketing healthcare costs and cumbersome diagnostic processes all contribute to lowering the level and speed of patient care.
CUUR Diagnostics is here to address these and many other issues that face both provider and patient in today’s ever-changing healthcare environment.
The SARS-CoV-2 Molecular Assay is a real-time RT-PCR test designed for the qualitative detection of nucleic acid from the SARS-CoV-2 virus extracted from respiratory specimens from individuals. This assay Testing is limited Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a certified high-complexity laboratories with FDA Emergency Use Authorization FDA for performing SARS-CoV-2 testing.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The assay is intended for use by CLIA certified high-complexity laboratories with experience in developing molecular diagnostics and is authorized under the Food and Drug Administration’s Emergency Use Authorization.
It’s clear that after hundreds of years of steady medical breakthroughs, the public health crisis of Antimicrobial Resistance poses a very real threat to our healthcare system. Developing new medicines isn’t enough. The discovery of new antimicrobials is too slow to keep pace with how quickly microbes are evolving rather we need to preserve the effectiveness of the ones we have.
Aligning with CUUR Diagnostics means having the ability to provide infectious disease molecular diagnosis with accuracy, affordability, accessibility, efficiency, sensitivity, specificity and ease of handling. Results are rapid, cost effective and reliable; offering increased sensitivity, specificity and speed.
Especially for microorganisms that cannot be or are difficult to cultivate, CUUR Diagnostics methods increase automation and standardization while decreasing the potential for human error. Our methods empower healthcare providers to make targeted treatment decisions sooner — reducing inappropriate antimicrobial use and the spread of resistance.
Leveraging the CUUR Diagnostics advanced molecular biotechnology means together we can improve patient outcomes, detect current and even emerging threats, and prevent the spread of antimicrobial resistance to save lives.