Molecular POC Makes Strides

Molecular POC Makes Strides

Make sure to visit our Point of Care Testing page, Kalorama's all-in-one resource covering the POC testing market. 

Molecular Point-of-Care (POC) devices are instruments that are able to perform complex diagnostic analyses, while being designed to minimize the time, resources, and effort required to do so. Due to their self-contained design, much – if not all – of the processing and analysis is fully automated, meaning that they can be operated with the bare minimum of interaction on the part of the user, and thus need very little training to use.   Kalorama covers molecular POC systems in its report, The Market and Potential for Molecular Point of Care (https://www.kaloramainformation.com/Point-Care-POC-10212249/).

As more tests using advanced technology become CLIA-waived –that is, approved for decentralized use, outside of traditional labs – the ability to provide accurate, central lab-quality results on demand has become increasingly prevalent over the last two years in physicians’ offices, clinics, emergency rooms, remote clinics, and other healthcare facilities. Rather than send patient samples to labs, a physician can analyze a sample using one of a multitude of small benchtop systems optimized to detect biomarkers for specific infectious diseases, such as influenza A/B (IFV) and respiratory syncytial virus (RSV), and streptococcus, among others. Not only does this expedite the results and arrive at a patient’s diagnosis more quickly, it also reduces potential complications and spread of disease, by relying on fewer people to run the tests.

Furthermore, the increasing portability of these instruments, the simplicity of their use, and the ability to use them outside of typical clinical environments make them especially vital in emerging nations and regions of low socioeconomic status, where access to state-of-the-art diagnosis techniques may not be so readily available. This has been taken into wide consideration, and more tests for infectious diseases associated with such places (e.g. Ebola) are being approved for CLIA waivers.

  • Cepheid: Cepheid produces the GeneXpert Omni, a fully automated PCR system with a small footprint (the size of a shoebox, as the company states); being battery-powered, it looks to be the most portable diagnostic device of its kind on the market. It uses the same cartridge system as its larger GeneXpert siblings, but internal components have been miniaturized and ruggedized to maximize portability for use on-site in the truest sense, making the Omni optimal for use in developing nations where resources and infrastructure are lacking or compromised. Its relatively diminutive design has an additional benefit: it is priced nearly 90% less than the next smallest device, the GeneXpert I. Finally, the unit is operated using a smartphone interface,with test results shared wirelessly and stored in the cloud. In addition to the requisiteIFV A/B and Strep tests, Cepheid has applications for detection of Ebola, tuberculosis, and HIV.

  • BioFire Diagnostics:BioFire’sFilmArray is a multiplex PCR system whose assays can detect dozens of possible biomarkers associated with meningitis/encephalitis, as well as respiratory, bloodstream, and gastrointestinal diseases, in one of each respective test unit. It automates sample preparation, DNA amplification, and detection in a single closed system, reducing operator interaction to two minutes. In November, parent company BioMerieux was given a CLIA waiver for the FilmArray Respiratory Panel EZ Configuration, which optimizes and simplifies the existing respiratory panel for use in primary care, pediatric, community, and family practice clinics. This particular assay can detect 11 bacterial and 3 viral pathogens associated with respiratory infections.

  • Roche:The cobas® Lab in a Tube (Liat) system needs only three steps for operation: pipet a patient’s sample into the assay tube, scan the barcode on the assay tube, insert the assay tube into the Analyzer. The tubes are comprised of a segmented series of pouches containing the reagents necessary for each assay; the Analyzer compresses the assay tube to release reagents from the segments and mix with the sample, controlling reactions at different temperatures, all in a pre-programmed sequence. PCR analysis produces accurate results in twenty minutes. Roche produces CLIA-waived assays for diagnosis of IFV A/B, RSV, and streptococcus group A, and has recently been given clearance for point-of-care diagnosis of methicillin-resistant staphylococcus aureus (MRSA/SA).

  • Alere: An improved technology is most useful when it can lead to changes in the test process, and this is the case with Alere’s i.  Traditionally, PCR uses a thermal cycling technique to amplify nucleic acids, denaturing the DNA at 95°C, cooling it to anneal primers to single-strand DNA templates, heating again to synthesize complementary strands of DNA for the template, and repeating the cycle dozens of times. However, the Alerei platform uses nicking enzyme amplification reaction (NEAR), an isothermal mechanism that requires neither a thermal cycler nor a DNA purification step, drastically reducing time and complexity.   The result is fast results - Alere claims that their CLIA-waived assays can detect IFV in 15 minutes, RSV in 13, and strep A in just eight minutes.

  • Spartan: The Spartan Cube is a tiny PCR device that integrates DNA collection, extraction, and analysis, and does so in a matter of thirty minutes. Like Cepheid’s GeneXpert Omni, it can connect wirelessly to a tablet or a laptop for convenient, portable access to results. Thus far, the Cube is expanding into Canadian pharmacies, hospitals, and physicians’ offices, and has three applications in the CLIA waiver pipeline: streptococcus A, legionella, and apolipoprotein E (ApoE, a protein with significant involvement in Alzheimer’s disease).

  • Biocartis: The BiocartisIdylla is a PCR platform with multiplexing capabilities (up to 30 molecular targets in one cartridge) that can offer a syndromic approach to diagnosis, similar to the BioFireFilmArray. The Idylla, however, appears to be primarily an oncology device,as the only infectious disease diagnostic designed for the system thus far is a respiratory panel (influenza A/B & RSV). Idylla promises to deliver results in 35 to 150 minutes with less than two minutes of hands-on time. As of now, there are three CE-marked in vitro diagnosis assays available for Idylla: BRAF and KRAS oncogene assays, and respiratory syncytial virus panel.

  • Mesa Biotech: Mesa’sAccula system, which is not yet available for sale, tests for influenza A and B, using a disposable assay-specific cassette that interfaces with a palm-sized dock, allowing medical professionals to get highly accurate results on-site in thirty minutes or less, presumably at a lower cost than with competing products. Mesa has recently received ISO quality certification, which brings them closer to making the Accula system commercially available in the EU and the United States.

The next steps for molecular POC testing should be to expand the scope of infectious diseases to be tested on site by improving sensitivity and selectivity for more biomarkers in assays, bringing them to the quality expected in centralize laboratories.  Another step would be to better distinguish between bacterial infections and viral infections so physicians know better what methods to use to treat illnesses. As stated above, some strides are being made on this front:BioFire’s offering does test for pathogens of both kinds in its respiratory panel. As multiplex PCR technology like that used with the FilmArray Respiratory Panel EZ is simplified, more tests will be CLIA-waived and brought right to the clinic.