Molecular point-of-care tests are starting to make a significant impression on the market. Dr Carmelo Volpe, commercial director at Enigma Diagnostics, tells Practical Patient Care about the importance of usability in device design, how best to reduce the risk of cross-contamination and what steps need to be taken before such devices are regularly reimbursed.
While many types of point-of-care (POC) testing have become commonplace in the clinical environment, molecular POC testing devices have taken longer to come to maturity. Molecule-based tests such as those for flu or RSV are highly complex and, for a long time, developers struggled to create devices that could carry out tests with laboratory-standard accuracy and consistency.
That has changed in recent years, as more and more developers demonstrate the ability to pack sophisticated
PCR amplification capabilities into increasingly portable, user-friendly packages. Most important, these devices are proving their accuracy in the clinical environment, convincing clinical and laboratory staff of their value as a quicker, equally effective alternative to traditional laboratory testing.
One company that forms part of this new wave is UK med-tech company Enigma Diagnostics. Its Enigma MiniLab is seeing a growing number of successful deployments, from A&E departments to bone marrow transplant clinics. A fully automated POC laboratory testing system, the MiniLab is designed to carry out a range of molecular tests while minimising the risk of cross-contamination and operator error.
Let's say an A&E department was conducting up-front flu tests to ensure that sick patients are prevented from contaminating others. A swab would be taken, put into a tube and then, instead of being sent to the lab for testing, the tube with the swab is placed in a cartridge containing the relevant reagents. The tube is never opened, eradicating risk of cross-contamination and ensuring a reading of the same accuracy that would be achieved in a laboratory setting.
According to Dr Carmelo Volpe, commercial director at Enigma Diagnostics, this design is indicative of efforts to tailor products to the needs of clinical staff, who are overworked enough without having to learn how to use a new machine. Training takes less than five minutes, and the process of inserting the swab into the cartridge around 35 seconds. Results come back in an hour and a half, as opposed to six-plus hours in the case of laboratory testing.
"I think it's down to manufacturers to fully understand the market and customer needs, not just to look at who has the best technology," he says. "The clinicians and microbiology laboratories don't want samples to be aliquoted by nursing staff or healthcare professionals as this can increase the risk of accidentally contaminating the sample. I think we've done a really good job of understanding what clinicians do and have kept the workflow as close as possible to what they do on a daily basis."
At the moment, customers are paying for molecular POC tests out of their own laboratory budgets. The next step is getting these devices approved for reimbursement so that they make greater financial sense to hospitals. This process is slow and requires a lot of supporting data. The National Institute for Health and Care Excellence does a good job of assessing technologies on the market, though Volpe would like to see it make clear recommendations on which devices to use. This, he believes, would help med-tech companies in the molecular testing space really stand out.
"You have all these new technologies coming out really quickly in comparison with the reimbursement evaluation process, which typically takes much longer", he says. "And that's fine - you are talking about people's health, so you want to make sure when a decision is made that it's the correct decision. There are a number of companies showing that you can move PCR or just amplification-based technologies outside the lab environment and that they can be successful. The pieces are in place. We probably just need one or two platforms to prove a major success for an alignment of all these components."
In the meantime, Enigma Diagnostics will continue to rack up case studies and data to back up its reimbursement cause. It is also developing new assays, including ones for multidrug-resistant tuberculosis, meningitis and carbapenem-resistant organisms, to help expand the scope of MiniLab.
"Some of these are time-sensitive critical infections, which you will want to know about and deal with as quickly as possible," says Volpe. "The value of a POC test is that it gives you an answer in a time frame that you can act upon. It allows the clinician to make a quick decision."