Frost & Sullivan has been exploring advances made in both non-invasive and implantable biosensors that will create opportunities for real-time monitoring technologies in health care. Read about several of these opportunities.
The earlier physicians and clinicians can detect diseases, the better the treatment outcomes. A promising diagnostic approach for this is the development of biosensors. These biomedical devices combine a biocatalyst, such as an enzyme, cell, or tissue, with a transducer. The biocatalyst will respond to a target biomarker of disease, and the transducer will convert that response into an electrical signal for analysis. The most common application in health care today is to determine blood glucose levels, though research is intensifying to use them for the rapid diagnosis of infectious diseases.
Frost & Sullivan has been exploring advances made in both non-invasive and implantable biosensors that will create opportunities for real-time monitoring technologies in health care. Several of these opportunities are discussed below.
Real-Time Zika Biosensor: Nanomedical Diagnostics Inc. (San Diego, Calif.)
The Zika virus, which is transmitted primarily by mosquitoes, is present in at least 85 countries. It can cause serious health problems including microcephaly in children and Guillain-Barre syndrome, where a person’s immune system attacks the nervous system. Diagnosis normally requires laboratory testing of bodily fluids. Nanomedical Diagnostics’ goal is to shorten the diagnostic time with its grapheme-based biosensor.
The company covalently links a highly specific immobilized monoclonal antibody with graphene particles—planar counterparts to carbon nanotubes—in its biosensor. The device is able to detect native Zika viral antigens in real time by measuring changes in capacitance of the graphene. Nanomedical Diagnostics demonstrated the sensitivity of detecting the antigens in concentrations as minute as 450 parts per million in a simulated human serum, and demonstrated the biosensor’s selectivity using Japanese Encephalistic NS1 viral antigen. The biosensor’s sensitivity and specificity, combined with real-time results, would make it a powerful tool in Zika diagnosis. Mindful of Zika’s presence in developing countries, the company used commercially available graphene sensors with Centers for Disease Control and Prevention antibodies to keep costs low.
Faster HIV Detection: Spanish National Research Council (Madrid, Spain)
A team at the Spanish National Research Council has developed a biosensor on a 0.5-millimeter chip that can detect type 1 human immunodeficiency virus (HIV) within a week after infection instead of the three to four wee4ks needed by the conventional viral ribonucleic acid with nucleic acid amplification test, also known as P24 antigen with immunoassays test.
The patented technology incorporates silicon micro
-structures holding gold nanoparticles that are functionalized with antibodies specific to P24. During testing, samples are held between the silicon structures and nanoparticles. As the nanoparticles efficiently scatter light, the microstructures detect minute intermolecular forces indicating the presence of HIV in concentrations 100,000 times lower than viral RNA and P24 immunoassay test systems. The technology has been licensed to Mecwins, a research council spin-off company, for further exploration.
The team is now adapting the biosensors for the early detection of some forms of cancer.
Real-Time Glucose Detector: PKvitality (Paris, France)
The discomfort and inconvenience of the traditional finger prick for measuring and monitoring diabetics’ blood glucose level led PKvitality to develop its pain-free glucose monitoring bracelet, called K’Watch Glucose. The user presses a button on the device to insert microneedles less than 0.5 millimeters into the interstitial fluid that surrounds cells in tissue. Interstitial fluid provides nutrients to cells, removes cellular wastes, and carries biomarkers including glucose.
Microneedles carry a drop of the interstitial fluid into the bracelet, whose K’apsul biosensor will analyze the concentration of glucose in the sample and send the data to a dedicated iOS or Android computer app. The device, which is not yet commercially available, does not break skin or nerve cells and does not cause pain. The company has been taking pre-orders since early 2017 as it pursues regulatory clearances.
Speedy Stroke Detection: Sarissa Biomedical Ltd. (Coventry, U.K.)
According to the World Heart Association, approximately 6 million people die and 5 million are disabled each year because of strokes. Inaccuracies in stroke diagnosis can delay treatment and affect outcomes.
Sarissa Biomedical is developing SMARTChip, a biosensor that will detect purines (a biomarker that is released at the onset of a stroke) within minutes to improve patient outcomes. SMARTChip is a portable, point-of-care device that uses a finger prick blood test to detect purines faster than the conventional—and less accurate—face arm speech test, or FAST, that paramedics use to diagnose suspected stroke patients. An observational study of 375 participants is continuing and is expected to be completed in June.
The Road Ahead
Frost & Sullivan has determined that biosensor development is being driven by the demand for accurate and early disease detection, the search for alternatives to complex conventional methods, declining sensor prices, and the demand for painless and intelligent devices that make patient monitoring less tedious. Several roadblocks remain, however, including the dominance of traditional diagnostics, high biosensor manufacturing costs, and the need for device standardization.
A major factor affecting the fortunes of biosensors is the regulatory reforms that are shaping the entire health care industry. The shift toward value-based care is compelling many physician practices to find cheaper alternatives to current care models. Frost & Sullivan believes that this will lead to more patient-oriented innovations that support more interactive and compatible platforms for better care and monitoring.
Before then, Frost & Sullivan researchers believe that the U.S. Food and Drug Administration’s cumbersome regulatory process and a lack of product standards will slow the acceptance of these innovative devices.
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