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Abbott’s $25 rapid Covid test cleared for home use in US by FDA

The Abbott news follows FDA’s clearance of the first at-home, over-the-counter Covid test on Tuesday from East Brisbane, Australia-based Ellume.

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Washington: Abbott Laboratories won U.S. authorization for a rapid Covid-19 test that costs $25 and can be used at home, a new accessible option from the manufacturer after months of obstacles to screening access in the country.

The emergency clearance from the Food and Drug Administration opens a new market for Abbott’s BinaxNOW, a single-use swab-collected test that produces results in 15 minutes. Until now, the test had been administered by health-care providers. Abbott is partnered with a service to remotely prescribe the screening.

The U.S. government purchased much of Abbott’s BinaxNow supply after the test was first authorized by regulators in late August. The company plans to make 30 million tests available for at-home use in the first quarter of next year and 90 million more in the second quarter.

Patients can order the test through the Abbott-developed Navica smartphone app, where they will fill out a series of health questions. Abbott’s prescribing partner, eMed, ships the test and virtually supervises its administration. Results are then delivered through the Navica app.

Although the need for rapid testing has risen during the pandemic, “unfortunately, we’re still hearing that many people can’t access testing as quickly as they need it,” Robert Ford, Abbott’s chief executive officer, said in a statement.

The new offering “allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy,” he said.

Accuracy study

In an ongoing study of 52 people who used the at-home offering within a week of developing symptoms, the test accurately produced positive results about 92% of the time, and correctly returned negative tests 100% of the time, the company said. The test was especially accurate for a subset of patients who were more likely to be infectious, according to Abbott, producing true positives in 100% of cases.

The Abbott news follows the FDA’s clearance of the first at-home, over-the-counter Covid-19 test on Tuesday from East Brisbane, Australia-based Ellume. Ellume will sell its rapid test in pharmacies and online for about $30, with plans to manufacture 100,000 a day starting in January.

Testing has been a key line of defense against the virus, but it has also been hard to access at times. People looking to get tested have often faced slow turnaround times, high costs and long lines, which presents particular challenges when people without symptoms may be infectious.

Public-health experts have called for making screening more accessible and criticized the FDA for moving too slowly on green-lighting new applications. While at-home options are a step forward, lower prices and more widespread access are still needed, some experts have said.

Medical setting

The vast majority of U.S. Covid-19 tests are performed in a medical setting and require a provider’s authorization, including an at-home test from Lucira Health Inc. cleared by the FDA last month. Last week, the agency cleared a test from Laboratory Corp of America Holdings that doesn’t require medical authorization but must undergo lab processing.

One of the priorities for regulators around at-home testing has been ensuring that it’s easy for the public to use and that results are reported to public-health officials.

Abbott partner eMed, led by former American Medical Association president Patrice Harris, will decide on users’ eligibility for the test, guide them through the screening process and conduct public-health reporting.

Abbott, which sells BinaxNOW for $5, said the $25 cost will include both the test and eMed’s services.-Bloomberg

Also read: US approves first at-home, over-the-counter Covid test, calls it ‘major milestone’


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