This is an extended version of content that appears in the Emerging Technologies feature in the April issue of CLP.
Faced with decreasing budgets and constrained resources, healthcare providers are seeking high-quality diagnostics that deliver efficiency in every way, from performance to results. With the unique capability of delivering multiplexed results in a rapid test format requiring just one drop of specimen, MedMira is developing a new class of diagnostic testing solutions for its customers.
Headquartered in Halifax, Nova Scotia, Canada, MedMira is developing a robust pipeline of tests based on its patented Rapid Vertical Flow (RVF) technology. The technology facilitates the formation of highly specific antigen-antibody reactions, allowing specific biomarkers in many sample types—including human whole blood, serum, or plasma—to be captured and visualized on a unique membrane.
In tests using MedMira’s RVF technology, the sample is applied from above and runs vertically through the membrane. As a result, the time required for a test result does not change when multiplexed to obtain several results: a single assay takes 2 minutes; obtaining five assay results will still only take 2 minutes. “Products built on the RVF platform can give practically instant results,” says Kevin Jones, PhD, MedMira’s senior director for global sales and marketing. “Such products are especially suited for use in counseling or instant-result settings, such as hospital emergency rooms or other emergency or disaster-response situations.”
Under its Multiplo brand name, MedMira is currently working on two multiplexed tests. The first is a combined HIV and syphilis test, primarily for the neonatal market, which is already in use in several Latin American countries. The second is a combined HIV, hepatitis B, and hepatitis C test, which has received approval for use in some countries. This product is currently going through FDA premarket review for entry to the US market.
“We foresee an increased demand for multiplexed assays,” says Jones. “In addition to testing for sexually transmitted viral diseases, for instance, it would be useful from an epidemiological perspective to be able to test for a variety of flu strains simultaneously. Similarly, multiplexed testing to identify the type of bacteria causing an infection would enable clinicians to select the correct antibiotic.”
MedMira is also working on a Canadian National Research Council project that is looking at alternate labels and reader technology, with the aim of further decreasing the lower detection limit of assays and making the reading of test results more straightforward. While readers and their algorithms require validation and raise the technology to a higher level of complexity, they may also offer strong benefits for a company focused on multiplexing.
“A visually read test can probably only handle five analytes, due to the need to allow for spatial resolution of the spots,” says Jones. “However, an instrument-read system could easily accept a 4 x 4 array within the current housing, and by using a smaller spot size the array could easily be increased to 10 x10.”
For further information, visit MedMira at www.medmira.com.