Bio-Rad Laboratories Rolls Out Shipping of Coronavirus Antibody Test
Bio-Rad Laboratories Inc. (BIO) has started the commercial launch of its blood-based kit test which is used to screen if patients have developed antibodies against SARS-CoV-2, the virus causing COVID-19.
The company, which makes test systems for medical diagnostics products, said that the test can help clinicians detect patients who have been infected by SARS-CoV-2 by checking if they develop an immune reaction to the virus. The test can be done manually or by using automated equipment. Bio-Rad asserts that antibody testing provides a more complete account of infection rates and immunity to help public health officials in their efforts to reduce containment rates.
Clinical evaluation of the SARS-CoV-2 antibody test has demonstrated diagnostic specificity of more than 99% and diagnostic sensitivity of 98%, Bio-Rad said. In addition, cross-reactivity testing showed specificity of 100% with no response against other interfering specimens including non-CoV-2 coronaviruses.
On an update on regulatory hurdles, Bio-Rad said the company has met the CE mark requirements for Europe and has applied for Emergency Use Authorization status awarded by the U.S. Food and Drug Administration.
“Having applied for FDA Emergency Use Authorization and meeting the requirements for CE marking, we have begun shipping the test and are in the process of scaling up manufacturing to meet demand in the weeks and months ahead,” Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President said.
Bio-Rad shares advanced 0.5% to $426.94 around midday trading on the New York Stock Exchange. Citigroup analyst Patrick B Donnelly yesterday raised the company’s price target to $480 from $425, while maintaining a Buy rating.
TipRanks data shows that Donnelly is 1 of 4 Wall Street analysts recommending investors buy the company’s stock adding up to a Strong Buy consensus rating. However, the $450 average price target suggests shares are poised to gain a mere 5.9% in the next 12 months. (See Bio-Rad Laboratories stock analysis on TipRanks).
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