Cue Health has been granted emergency use authorization for an over the counter COVID-19 test. The San Diego, CA-based company’s test is aimed at consumers ages 2, and older – without the need for a prescription.
The molecular nucleic acid amplification test is designed to detect genetic material from the SARS-CoV-2 virus. It uses a lower nasal swab and delivers results in about 20 minutes to the user's mobile smart device. Each Cue OTC Test Cartridge Pack includes the single-use, self-contained Cue Test Cartridge and the Cue Sample Wand.
In prospective studies to evaluate the use of the Cue OTC Test, the results were 97.4% agreement for positive cases and 99.1% agreement for negative cases compared to the results from a highly sensitive EUA PCR laboratory-based test.
This is the first molecular diagnostic test available without a prescription,” said Ayub Khattak, Co-Founder and CEO of Cue. “For the first time, consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of COVID-19 testing.”
The EUA follows another significant milestone Cue has had in recent months. The company raised a sizeable $100 million in a Series C financing back in June to help with the development of its molecular COVID-19 diagnostic.
Even as the story is becoming more about vaccine deployment – there are still significant developments in virus testing. Abbott Laboratories recently received EUA for a laboratory PCR Assay that detects and differentiates SARS-CoV-2, Flu A, Flu B, and RSV in One Test - and FDA EUA for Asymptomatic Usage of Alinity m COVID-19 test.
The Abbott Park, IL-based company was able to bring in $2.4 billion in COVID-19 testing-related sales for its 4Q20 earnings. Robert Ford, Abbott’s president and CEO spoke on the impact of the company’s testing efforts.
“We realized very early that a variety of different testing solutions would be required to tackle the pandemic,” Ford said according to a Seeking Alpha transcript of the earnings call. “With that understanding, starting last March we developed and launched an entire portfolio of tests to target the virus. The biggest contribution in the fourth quarter came from our rapid lateral flow test to detect the virus, which includes BinaxNOW in the U.S. and Panbio internationally. These are highly portable, reliable, and affordable tests and in just 15 minutes can detect if someone is infectious without the use of an instrument, which means the test can be performed in virtually any setting, such as physician offices, pharmacies, urgent care centers, workplace settings, and even at home.”