Dive Brief:
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OraSure Technologies has won emergency use authorization for three versions of its InteliSwab COVID-19 rapid antigen tests.
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Each version features a swab integrated into a test stick. After being used to collect a sample from the lower nostrils, the swab is put in a solution and the result displays on the integrated test stick in 30 minutes.
- The technology is somewhat differentiated from other rapid antigen tests but is coming to market amid what Abbott Laboratories characterized as a "sharp and rapid" drop in demand for COVID-19 tests.
Dive Insight:
OraSure received Biomedical Advanced Research and Development Authority support to develop a rapid self-test for coronavirus antigens in April 2020. At that time, OraSure expected to develop the test over four to six months and then seek an EUA. Ultimately, OraSure received the EUA 14 months after disclosing the BARDA funding.
The rapid antigen test market has been through multiple phases over those 14 months, from early skepticism about accuracy through to surging sales and now to the "sharp and rapid" drop in demand seen by Abbott.
OraSure is now set to try to carve out a piece of the shrinking market. The EUAs cover a prescription home test, an over-the-counter home test and a professional-use test. The populations covered by the EUAs differ somewhat but the technology is the same.
OraSure CEO Stephen Tang argued the technology can set InteliSwab apart from the competition.
"We believe that this easy and intuitive 'swab, swirl and see' test will be one of the simplest COVID-19 tests on the market," Tang said in a statement.
The sensitivity and specificity figures reported in the EUAs are in line with the data on some other rapid antigen tests, clocking in at 84% and 98%, respectively, when samples were analyzed within seven days of symptom onset. Quidel's QuickVue At-Home COVID-19 Test, for example, received EUA with a sensitivity of 85% and specificity of 99%.
OraSure's EUAs come tied to certain postmarket requirements. FDA wants the company to carry out a post-authorization analytical bridging study, evaluate performance in people aged 15 years and younger and develop a mobile app or website to facilitate results reporting. OraSure has four months to comply with the requests.
