Lucira Health COVID All-In-One Test Kit
… Lucira Health COVID All-In-One Test Kit …

FDA Approves First At-Home COVID-19 Test

Lucira Health launches its COVID-19 All-In-One Test Kit for consumer and medical professional use

John G. Baresky

The U.S. Food and Drug Administration (FDA) has issued emergency use authorization for Lucira Health’s at-home COVID-19 test. It is the first COVID-19 diagnostic resource that can be administered and completed entirely at home without requiring the resources of a laboratory. The well-designed and easy to use test produces accurate results in about 30 minutes.

Lucira’s product, known as the Lucira COVID-19 All-In-One Test Kit, is available as a single-use product. A household of 4 individuals would need to purchase 4 separate tests if they all wanted to know their COVID-19 status. Its quick, accurate results and its lab-free process is universally attractive to a variety of market segments as it saves time and money.

In addition to consumers, the Lucira COVID-19 test can potentially be used by clinics, medical groups, hospitals, health systems, long-term care facilities, military bases and other point-of-care locations.

The Lucira COVID-19 test is administered with a nasal swab. A sample is collected from the test subject’s nose with the swab which is then stirred into a sample vial which is placed into the primary test unit. The main test unit has a user-friendly light-up display that clearly indicates positive or negative results.

The price is reportedly in the range of $50 per test however this is highly subjective depending upon the markup a retailer or other reseller assigns to it. At the moment, it’s still too early to tell if payers such as managed care organizations, health insurance companies, Medicaid or Medicare plans will cover part or all of its costs for consumers or healthcare provider organizations.

Lucira Health is a compact, privately-held company based in Emeryville, California. Founded in 2013, it specializes in infectious disease diagnostics. The Lucira COVID-19 All-In-One Test Kit is manufactured in the United States. It is not known what their daily production volume is but demand is expected to be extraordinarily high as Roche Diagnostics quickly escalated its COVID-19 diagnostic test production following its approval.

If necessary, there is the potential for Lucira Health to be eligible for HHS funding to quickly invest in its manufacturing facilities as Cue Health did to ramp up its COVID-19 test production volume. Lucira Health’s clinical and technical innovation is making a significant difference in the global fight against COVID-19.

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