Abbott Laboratories (ABT)

[DewDiligence]

FDA approves ABT’s BINAX-NOW COVID-19 test—produces result in 15min on credit-card-sized card with no additional instrumentation—price is only $5/test:

https://www.prnewswire.com/news-releases/abbotts-fast-5-15-minute-easy-to-use-covid-19-antigen-test-receives-fda-emergency-use-authorization-mobile-app-displays-test-results-to-help-our-return-to-daily-life-ramping-production-to-50-million-tests-a-month-301119289.html

Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection.

Abbott will sell this test for $5.

It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider.

…Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities…

…In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

…Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.

…Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.

The PR above has an image of the compact (credit-card-size) test card.

BinaxNOW uses lateral flow (rather than PCR) to detect COVID-19 antigens (rather than COVID-19 RNA) from a standard nasal swab.

The $5/test price and ABT’s massive manufacturing scale make BinaxNOW a truly differentiated testing solution.