Idexx Unit Gets European Union Regulatory Nod For Covid-19 Test Kit


Idexx Laboratories Inc.’s (IDXX) subsidiary Opti Medical Systems, Inc., announced that it has received the European Union’s regulatory CE mark approval for its laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19.

The Opti SARS-CoV-2 test kit uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology and is developed to provide results in about 2–3.5 hours.

“The CE mark certification is an important step in advancing our efforts to support critical COVID-19 testing,” said Olivier te Boekhorst, Corporate VP and General Manager of Opti Medical Systems. “We are committed to helping our communities around the globe and will continue to work with regulatory authorities and customers to expand the availability of diagnostic testing.”

In addition, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Opti’s DNA/RNA magnetic bead kit for nucleic acid extraction from respiratory samples to be used with the Opti SARS-CoV-2 RT-PCR test kit. This will enable Opti Medical Systems to provide laboratories with a complete manufactured workflow solution for COVID-19 testing, the company said.

Opti’s RT-PCR laboratory test kit has previously been approved by the Institut Pasteur of France and has also received EUA by the FDA.

Shares in Idexx Laboratories have climbed about 70% since reaching a multi-year low in March. The stock rose 0.5% to $311.71 as of Friday’s close.

Five-star analyst Erin Wright at Credit Suisse recently reiterated his Buy rating on the stock with a $300 price target, as weekly clinical visit trends turn positive.

“While we acknowledge near-term COVID-19 headwinds remain, the reported patient visit growth underscores our view of IDXX as a compelling alternative investment, with durable revenues and consistent price realization in a healthy longer term fundamental backdrop, contributing to greater predictability and visibility on growth,” Wright wrote in a note to investors.

The rest of the Wall Street analyst community is cautiously optimistic on Idexx stock. The Moderate Buy consensus consists of 3 Buy versus 2 Hold ratings. The $300.75 average price target now indicates 3.5% downside potential in the shares, following the sharp rally this year. (See Idexx stock analysis on TipRanks).

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