Sona Nanotech (CSE: SONA) last night finally announced it is waving the white flag on its COVID-19 rapid saliva test. The company has terminated a licensing arrangement it had in place with Arlington Scientific following the results of two clinical studies conducted on the test.
Evidently, studies and consultations with the US Food and Drug Administration did not go as the company intended, with the test proving to be too ineffective to be useful. Test results revealed a sensitivity of 88% for the test specifically within a point of care environment, where patients had to have a viral load so high that they would be contagious before the test would detect the presence of the virus.
In wider testing however, sensitivity of the rapid saliva test came in at just 62%, far below the 80% threshold to be deemed effective. The company simplifies the results by stating that “the test worked well with contagious subjects but not as well with subjects whose viral load was low.” Point of care specificity meanwhile came in at 94%.
Outside point of care testing, a study was also conducted for self-testing using the rapid saliva kit, wherein sensitivity was 70%, and specificity was 81%. Guidelines currently in place by the FDA expect mid-to-high 90% for both those figures.
Following the results, the company indicated that due to “deteriorating market dynamics” as well as the preference for over-the-counter testing options by the FDA, it will not be proceeding with further studies or commercialization efforts on its rapid saliva COVID-19 test. Instead, the firm will be focused on the development of concussion and bovine tuberculosis rapid test, along with continuing the development of its gold nanorod manufacturing tech.
The development follows the news from last year, wherein the company discontinued clinical trials of the rapid antigen saliva test, at the time citing inadequate test sensitivity.
Sona Nanotech last traded at $0.16 on the CSE.
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