A rapid 1 hour sample-to-result molecular diagnostic assay to monitor the presence of life-threatening viruses in patients who are undergoing solid organ transplants is now commercially available in Europe.

The NeuMoDx™ diagnostics company have released its molecular assays for cytomegalovirus (CMV) and Epstein-Barr virus (EBV) which run on its two NeuMoDx molecular systems – the NeuMoDx 288 and the NeuMoDx 96. Viral load is especially important in monitoring disease progression and these systems have been proven to provide rapid and accurate quantitative results. The NeuMoDx systems perform extraction, amplification and interpretation of results automatically.

Both of these viruses are members of the herpes family, and both cause serious complications during surgery. The viruses can be replicated if the organ donor is seropositive or because these viruses are present in 90% of the population, mostly in a latent state, can be re-activated due to the application of immune-suppressive drugs used to prevent the immune system from attacking the transplanted organ.  

NeuMoDx claim the assays along with their reagents NeuDry™ can ease workflow in the lab. The high throughput automated system can run by itself for up to 8 hours and their reagents have an ambient shelf life of greater than one year requiring no refrigeration, which will cut down on costs. They also state their reagents are unitized, thus reducing the amount of waste that goes with usual manual reconstitution of reagents.

At the recent 2019 conference of European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in the Netherlands, NeuMoDx presented their CMV assay results, which were determined using the 1^st WHO international standard for CMV: “Evaluation of analytical sensitivity of the NeuMoDx CMV Test gave a LoD and LLoQ of 20 IU/mL. The NeuMoDx CMV Test demonstrated excellent linearity across clinically relevant >6 log dynamic range with a slope of 0.99 as well as quantitative precision across 3 systems over 12 days, and equivalence across multiple reagent lots. Turnaround time for the NeuMoDx CMV Test was ~60 min. No cross-reactivity was detected against any of the 35 non-target pathogens tested and there was no interference observed against the 33 endogenous or exogenous agents tested. A method correlation study conducted between the NeuMoDx CMV Test and the reference tests showed excellent linear correlation and a bias of 0.24 log10 IU/mL.  

In September last year, QIAGEN and NeuMoDx™ went into partnership with QIAGEN responsible for distributing NeuMoDx systems in Europe. NeuMoDx are currently being sued by Becton, Dickonson and Company (BD) over patents that BD claim were purchased when they bought over Handylab from Jeff Williams who then went onto start NeuMoDx. BD claim that the patents purchased under the agreement are still being utilized by NeuMoDx™ and being made commercially available, which they say constitutes as patent infringement.

Source Article: www.neumodx.com