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QuidelOrtho pulls FDA submission of 4-virus test

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Dive Brief:

  • QuidelOrtho said it has withdrawn a 510(k) submission for its Savanna four-virus respiratory test because the final data set for the assay did not meet the company’s expectations.
  • The diagnostics company, which is currently searching for a permanent chief executive after firing longtime CEO Douglas Bryant in February, said it is developing a next-generation RVP4+ assay that it expects to be commercially available during the 2024-25 respiratory season.
  • Analysts said the test was expected to be a key sales driver for the company’s Savanna PCR platform. “This is a required assay to help drive a meaningful number of platform placements,” William Blair analyst Andrew Brackmann said in a note to clients on Tuesday.

Dive Insight:

Bryant’s departure from QuidelOrtho followed the company’s first full year as a combined organization after Quidel acquired Ortho Clinical Diagnostics for $6 billion in May 2022. The merger of the two in vitro diagnostics companies was designed to target a $50 billion total addressable market and benefit from significant synergies, but the deal received a chilly reception from investors.

QuidelOrtho posted a decline in revenue and a net loss for the full-year 2023, and analysts expressed disappointment with the company’s 2024 forecasts.

Interim CEO Michael Iskra, at a recent investor conference, said the company planned to accelerate a previously announced headcount reduction and would lay off less than 10% of its global workforce in an effort to cut costs and focus on growth opportunities in areas including molecular diagnostics.

QuidelOrtho secured FDA 510(k) clearance for the Savanna molecular testing platform in December. Noting it is committed to building a menu for the platform with the highest-quality assays, the company said nine-month data for the four viruses targeted by the RVP4+ test “initially showed great promise.”

The company made its FDA submission for the assay in July, but decided to withdraw the application after the final data set, submitted in February 2024, did not meet its expectations. The test is intended to detect and differentiate between influenza A, influenza B, respiratory syncytial virus and SARS-CoV-2.

QuidelOrtho’s shares closed down more than 10% to $42.15 on Nasdaq Tuesday after the news.

William Blair’s Brackmann said that while management did not provide much detail about what went wrong with the submission, “the company did say it has conducted significant analysis on the test and is well along with work on the new panel.”

Brackmann pointed out that competitor bioMérieux recently obtained 510(k) clearance for its respiratory panel. “This is critical time that is potentially lost” for QuidelOrtho, the analyst said.

On Tuesday, QuidelOrtho also announced it received 510(k) clearance for its QuickVue COVID-19 test. The company said it remains committed to expanding the Savanna platform menu and is making progress on a sexually transmitted infection panel. It expects to begin clinical trials for that test later in the second quarter.

Susan Kelly

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