Kaya17

Month: October 2020

Kaya17 completes its second clinical validation of a rapid COVID-19 antigen test with PCR-level accuracy on nasal swab samples

Kaya17 Inc., the developer of an innovative Point of Care test for COVID-19 and other medical diagnostics applications, completed its first clinical validation study in collaboration with paradigm labs, Tucson, Arizona.

Paradigm labs is one of the leading testing entities for COVID-19 in the state of Arizona and routinely performs thousands of nasal swab-based RT-PCR test of COVID-19 tests per day. Kaya17 is the first company to have developed a rapid (15min) saliva test with PCR level accuracy. It offers a complete system with test kit, reader, and software.

Two hundred samples were run in this test using two readers supplied by Kaya17 and samples procured from patients by Paradigm Labs. The tests were run at the Tucson facility by Paradigm personnel. Since Kaya17’s system is easy-to-use, Kaya17 was able to train the paradigm personnel to operate its reader and software in less than 30 min. Techicians trained on Kaya17’s test found that it was so much simpler to operate, unlike many other commercial PCR tests that require elaborate training.

This study was a retrospective clinical study with nasal swab samples collected in viral transport media (VTM) for the Kaya17 test and stored in refrigerator form. The validation was done against the RT-PCR test of Paradigm labs that is already FDA approved.

The test on 200 samples was completed using the Kaya17 system in less than 8 hours ( ~25 samples/hr). Two readers were used to validate repeatability of results. Kaya17 test to RT-PCR matched in 97% of the cases. The sample set contained approximately an equal set of positive and negative results.

Kaya17’s CSO, Dr. Camille Troup, said, “Proving that our tests work with both saliva and nasal swab samples gives us an added level of confidence. However, saliva samples are much easier to procure and are much more “patient friendly”. The 97% agreement with RT-PCR is very encouraging.”

Kaya17 Complete First clinical validation study at Arizona State University Biodesign Institute

Kaya17 Inc., the developer of an innovative Point of Care test for COVID-19 and other medical diagnostics applications, completed its first clinical validation study in collaboration with Arizona State University, Biodesign Institute, Phoenix, AZ.

In response to the pandemic crisis, the Biodesign institute has converted its state-of-the-art research infrastructure into an FDA-approved and clinically certified diagnostics lab capable of performing thousands of COVID-19 tests per day. The Biodesign institute is one of the early developers of saliva-based PCR tests. Kaya17 is the first company to have developed a rapid (15min) saliva test with PCR level accuracy. It offers a complete system with test kit, reader, and software.

Ninety-six samples were run in this test using two readers supplied by Kaya17, with samples procured from patients by the Biodesign Institute. The tests were run at the Biodesign institute by Biodesign institute personnel who went through a 20-minute training.

This was a retrospective study with neat saliva samples collected for the Kaya17 test. The validation was done against the FDA-approved RT-PCR test for saliva, developed by the Biodesign Institute. The same person’s samples were tested by Kaya17 and RT-PCR.

The test on 96 samples was completed using the Kaya17 system in less than 3 hours (30 samples/hour). Two readers were used to validate repeatability of results. Kaya17 test matched to RT-PCR results in 98% of the cases. The sample set contained an equal set of positive and negative results and were all from asymptomatic subjects.

Kaya17 CEO, Dr. Sulatha Dwarakanath, one of the co-founders of the company said, “I am excited to see the high sensitivity of our test and 98% correlation to RT-PCR. The fact that our test is rapid and can be used at the point of use will make it possible for the economy to get back into gear.”

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