Did you miss the 2018 Molecular Diagnostics Europe conference in Lisbon, Portugal? Even though you may not have seen the São Jorge Castle or tasted the great food- here is what was important!
Hot Topic #1: Finding Alternatives to Lyophilization and Cold Storage
One of the motifs at MDx Europe was a general shying away from cold storage and freeze-drying methods. Cold storage is a logistical nightmare for many industries and companies, aside from those in the molecular diagnostics space. Samples must be preserved and shipped in bulky, waste generating containers that may or may not preserve the sample during its journey. The same can be said about reagents in devices and cartridges. These reagents need to be stored at lower temperatures to prevent degradation that could result in shorter shelf-life. As far as lyophilization, many attendees believe that the high cost of freeze-drying capital equipment and time investment needed up front create a huge barrier for innovation. We here at Biomatrica tend to echo this sentiment.
Hot Topic #2: Sample Standardization
Another point of discussion at the conference was an interest in learning more about how to standardize samples and sample collection for reproducible results in downstream applications. Many were curious to find out the best method of collecting and stabilizing CTCs and cfDNA in order to minimize the occurrence of false negatives in testing. It is essential to choose the ideal workflow (from sample collection to storage and analyte isolation) early on, as it is very difficult to make changes once a full workflow has been validated with a certain set of conditions. Comparing multiple options under stressed conditions minimizes the chance of false negative results.
The conference also had worthy buzz-level around RNA, cfRNA, and exosome collection and analysis. Although epigenetic alterations of cfRNA and miRNA in the early stages of biomarker development and clinical validation have not been fully established, changes in gene expression patterns might provide additional clues towards a patients’ disease state. Consensus on standardized conditions for extraction and purification of these biomarkers will be key to reaching their full potential.
Hot Topic #3: Point-of-Care Diagnostics
MDx Europe also put quite the emphasis on point-of-care Diagnostics. The industry is moving toward self-testing that puts the sample collection and testing in the hands of the patient rather than the healthcare provider. Attendees expressed interest in sample analysis of saliva, urine and other generally non-invasive samples. As the molecular diagnostics industry moves to point-of-care, a greater priority will be given to at home sample collection and testing which will need to be standardized and made user-safe/user-friendly.
Another point made at MDx Europe (and worth noting) was regulatory changes being made to CE-IVD product approvals by 2022. There is still confusion regarding the fate of existing regulated products, and additional feedback from the agency is needed. New products looking to be CE-IVD marked will undoubtedly have to abide by the new rules and regulations put forth. More information on this to come…
For a beginner’s guide to the current IVD Directive, check out this guide.
So there you have it- three of the hottest topics at MDx Europe 2018!
Contact us to find out more about how Biomatrica’s products can address your sample standardization needs, provide an alternative to your cold-storage, or complement your POC diagnostic!