SensiVida Medical Technologies, a developer and provider of minimally invasive diagnostic technologies and devices, has presented the company's first clinical results using its minimally invasive allergy test as cleared by the Western Institutional Review Board (WIRB) of Olympia, Washington.
Under the supervision of clinical and research staff at the Allergy, Asthma, Immunology of Rochester (AAIR) Research Center, SensiVida’s test was benchmarked against the well-known ‘Skin Prick Test’ using the same allergens and subjects. Dimension and color of allergic responses produced by SensiVida’s test were compared with reactions produced by the Skin Prick Test with the aim of quantifying extent of reaction, test time, and accuracy.
SensiVida’s test device was found to reduce the area of allergic reactions, be painless to the patient, reduce time required for the test, enable allergic reactions to dissipate rapidly.
SensiVida’s ‘non-significant risk’ test device was found to reduce the area of allergic reactions by a factor of four or more when compared with to Skin Prick Test. As a result, only small areas on the subjects’ arms were tested and all reactions were accurately monitored using the company’s microsystems and image science technologies.
Test-to-test variation for each subject was found to be less than 10%, lower than when using the same allergens with the Skin Prick Test. Negative control (saline) reactions with the SensiVida test were virtually absent, an indication of negligible trauma inherent in its minimally invasive technology. The early results are promising since test variation often leads to uncertain diagnosis of allergies, and at times may indicate further testing is required.
From the subject’s point of view, SensiVida’s test was not only totally painless, but test time was shorter due to more efficient patient prep, faster allergic reaction times, and faster data acquisition. SensiVida’s test was virtually complete after 10 minutes, at least one third the time required by the Skin Prick Test.
In addition to the benefits, SensiVida’s allergy test automatically creates an Electronic Medical Record that includes patient information, allergy reaction data, and supportive image video files.
Jose Mir, president and CTO of SensiVida, said: “We are very pleased with these results. SensiVida seeks to replace today’s painful, inaccurate, and laborious skin allergy test with a pain-free, productive, accurate, digital option.
“Although these data still represent a statistically small sample, SensiVida is encouraged by its painless test results, diminished reactions and low variability when compared with today’s standard test. The company will continue to gather clinical data under WIRB clinical test guidelines as it continues product development efforts and commercialization.”