Dive Brief:

• FDA has granted emergency use authorization to Quidel’s QuickVue At-Home COVID-19 Test. The product makes lateral flow technology used by healthcare professionals available to the public, albeit initially only on a prescription basis.

• An analyst at Craig-Hallum called the EUA "the first step in morphing at-home testing into a multi-billion-dollar market," while acknowledging that over-the-counter clearance is still needed to unlock the full commercial potential of the product line.

• Several other companies including Abbott already sell fully at-home COVID-19 tests, one of which is available over the counter. The at-home sample collection market is also getting more congested, with Eurofins securing an EUA for its OTC product on Monday. Currently, there are 38 molecular authorizations by FDA that can be used with home-collected samples.

Dive Insight:

FDA issued a flurry of EUAs for at-home COVID-19 tests late last year. Lucira Health secured clearance to sell its single-use, 30-minute molecular test kit with a prescription in November. The following month, Abbott received an EUA for its prescription at-home rapid antigen test and Ellume secured clearance to sell a similar product OTC to people with or without coronavirus symptoms.  

On Monday, FDA gave Quidel the green light for a version of its QuickVue antigen test for home use. The EUA covers symptomatic people aged 8 years and older on the strength of a study that found its positive results concurred with PCR 84.8% of the time. Negative QuickVue results agreed with PCR 99.1% of the time. The sensitivity is lower than for the QuickVue product aimed at healthcare professionals, potentially due to swab self-collection.

NIH on Monday announced it has launched a study to assess performance and usability of a smartphone app paired with Quidel's QuickVue at-home antigen test, which provides results in 10 minutes. "As rapid, at-home COVID-19 tests like QuickVue become more widely available, companion smartphone apps are expected to play an important role in their successful use" by providing step-by-step test instructions, according to NIH.

Quidel's EUA positions it to compete for the prescription at-home COVID-19 testing market. The size of that market is unclear and its long-term prospects are doubtful. However, an analyst at Craig-Hallum contends the significance of the EUA extends well beyond the near-term COVID-19 opportunity.

"[Quidel] has internally developed at-home tests for flu and strep years prior, but interest seemingly deflated at FDA. With the population hyperaware of disease now, at-home tests are a no-brainer for 2021 and beyond. In a few years it may look odd to not have routine tests that can be pulled from the local pharmacy shelf (or shipped via online retailers) and placed near the box of Band-Aids for easy, anytime infectious disease testing," the analyst wrote in a note to investors. 

The analyst sees OTC authorizations as critical to the realization of that vision. Ellume received an OTC authorization in December but is still ramping up manufacturing. The big companies that could bring a step change in OTC test availability are yet to receive authorizations to provide kits without a prescription.

Quidel is working on an OTC approval but last month said it was running behind schedule due to the time needed to generate enough positive results in asymptomatic individuals. 

News of Quidel's prescription authorization emerged on the same day that Eurofins disclosed an EUA for its at-home sample collection kit. The kit is available without a prescription but, unlike tests sold by Abbott, Quidel and their rivals, requires users to send a sample for processing at a laboratory. Only the sample collection step is done at home.