Quidel’s Lyra Covid-19 Test Gets Nod For Sale In Canada; Shares Rise 6%

Quidel announced that it received regulatory authorization to market and sell its Lyra Direct SARS-CoV-2 test in Canada, sending shares up almost 6%.

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The stock rose to $253.50 in early afternoon trading. Quidel (QDEL) said that under the terms of the authorization by Health Canada, the Lyra Direct SARS-CoV-2 test does not require an upfront sample extraction, which removes supply bottleneck. The Lyra Direct test uses a reformulated buffer that replaces extraction with a simple 10-minute heat step, saving approximately 50 minutes in processing time. The assay can run on any of seven possible thermocyclers.

The Lyra testing includes unique features that provide for simple transport and storage, improved workflow, shorter time to result, and other benefits that favorably affect diagnostic test outcome, the company said.

“The Lyra SARS-CoV-2 Assay provides these and certain additional advantages over many other tests currently on the market for this novel coronavirus, including easier set-up and faster time to result,” Quidel said in the statement.

In addition to Canada, the test is currently available for sale in the US under emergency use authorization, and in Europe under the CE Mark.

Back in May, the diagnostics company was granted emergency use authorization by the US Food and Drug Administration (FDA) for its Sofia antigen testing, a rapid point-of-care test for suspected COVID-19 infection. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes.

Driven by the company’s focus on Covid-19 antigen testing, Quidel shares have put on a dramatic rally recently, and are up an impressive 238% year-to-date. Meanwhile, the stock has a cautiously optimistic Moderate Buy analyst consensus, with the $361.50 average analyst price target indicating another 43% upside potential for investors over the coming 12 months.

After the company beat Q2 results, Craig-Hallum analyst Alexander Nowak at the end of last month raised the stock’s price target to $363 (43% upside potential) from $306 and maintained a Buy rating. (See QDEL stock analysis on TipRanks)

The analyst said that the Q2 call demonstrated the massive demand for Quidel’s Covid-19 tests and the positive effect it is having on margins and profitability.