August 28, 2020 – Quidel Corporation (San Diego, CA) yesterday announced business updates and reaffirmed that it is “an industry leader in the introduction of FDA-authorized rapid tests for a wide range of diseases and medical conditions, [and] remains in the forefront of the battle against the COVID-19 pandemic.”
Competition Was Expected
“Abbott’s entry into the SARS antigen testing market was fully anticipated, as was the potential scale of visually read lateral flow assays,” Quidel said.
“The assay performance described in the package insert is unsurprising as well and is very encouraging as it further validates the utility of rapid immunoassay technology in addressing the critical testing needs of our nation. The suggestion of lower product pricing was also expected, given how the Alere BinaxNOW Influenza A+B Card had been previously priced relative to other rapid influenza products, including Sofia Influenza A+B, the premier product and market leader in rapid influenza testing.”
Differentiating Features
Quidel says its Sofia system features “an objectively read result, internal controls that ensure testing accuracy, and the Virena data management system, which provides aggregated, de-identified testing data in near real-time to thousands of hospital systems, urgent care networks and public health officials.
“These differentiating features are valuable to customers and help to explain the price difference between Sofia assays – like Influenza A+B, Strep A and RSV – and visually read products,” said Quidel.
Challengers Welcome
“Another SARS Antigen product from a high-quality company with scale like Abbott is welcome. The validity of rapid antigen testing has been questioned by some, including state public health officials, and together with Abbott, BD and perhaps others, we can begin to change this mindset and to expand the utility and demand for this technology,” said Douglas Bryant, president and CEO Quidel Corporation. “Another entrant into the segment doesn’t change our plans to develop or manufacture any of the products in our pipeline, doesn’t change our marketing plans, and has no impact on our financial forecast at this time.”
