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Abbott And Quidel: The Test Makers That Survived

Abbott sold about $7.7 billion of COVID-19 tests in 2021 and $297 million in 2025. Quidel sold about 65 million QuickVue antigen tests in the last quarter of 2021; in 2025 the merged QuidelOrtho booked $80.2 million of COVID-19 revenue for the whole year. The product that carried both was the rapid test: a box in a pharmacy, a cartridge in a clinic, a lateral-flow strip on a kitchen table.

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Abbott and Quidel were established diagnostics companies that converted emergency demand into real sales, then had to live through the demand collapse. Unlike the fly-by-night storefront, the reimbursement opportunist or the lab with a state complaint, they were the incumbents of the testing boom: they built, sold, and survived.

FDA authorized Quidel's antigen test in May 2020 and Abbott's in August 2020

FDA's emergency-use pathway let tests enter the market before the ordinary device-clearance process would have run its full course. The emergency gate still carried authorization letters, labeling conditions, settings of use, and later revisions.

Quidel was early in that gate. FDA's authorization letter for the Sofia 2 SARS Antigen FIA says the agency issued an EUA on May 8, 2020, for qualitative detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal or nasal swabs, authorized for use at the point of care in CLIA-certified settings that met the relevant requirements.1

Abbott's BinaxNOW letter says FDA issued its EUA on August 26, 2020, for the BinaxNOW COVID-19 Ag Card. The initial authorization was professional/point-of-care.2 The over-the-counter shift came later, when Abbott announced the March 2021 EUA for the BinaxNOW self-test for asymptomatic, non-prescription, multi-test use.3

Abbott's COVID testing sales: $3.9 billion in 2020, $7.7 billion in 2021

In its 2021 Form 10-K, Abbott said COVID-19 testing-related sales totaled about $3.9 billion in 2020 and $7.7 billion in 2021. The 2021 figure was led by roughly $6.6 billion in combined sales from the BinaxNOW, Panbio, and ID NOW rapid-testing platforms.4

The public did not need to understand sensitivity, specificity, antigen detection, or PCR confirmation rules to understand a box on a shelf. Abbott sold the box.

In January 2021, Abbott said it was completing the U.S. government order for 150 million BinaxNOW COVID-19 tests and would supply another 30 million tests through March under a new government order.5

By 2025, Abbott's COVID testing sales were $297 million

By 2025, Abbott's annual report said COVID-19 testing-related sales had fallen to $297 million, down from $747 million in 2024 and $1.6 billion in 2023.6

That is a fall of 96 percent from 2021.

Abbott survived because Abbott was never only a COVID testing company. Diagnostics was still a major segment in 2025, but Abbott's annual report also discusses medical devices, nutrition, established pharmaceuticals, diabetes care, and emerging-market sales.6

Quidel sold 65 million QuickVue tests in one quarter

Quidel was more exposed to the respiratory-testing swing.

The company had two key rapid-testing products in the pandemic: Sofia SARS antigen tests and QuickVue COVID-19 antigen tests. In January 2022, Quidel announced preliminary fourth-quarter 2021 results and said it had sold about 65 million QuickVue COVID-19 antigen tests and more than 4 million Sofia SARS antigen tests in the quarter, the highest quarterly test sales volume in the company's history.7

That was the Omicron quarter.

QuidelOrtho later said its Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance in March 2023, making it the first rapid antigen COVID-19 test to receive that type of market clearance.8 The product category moved, at least in part, from emergency authorization toward a conventional device pathway.

Quidel bought Ortho; respiratory revenue still fell 20 percent in 2025

Quidel later merged with Ortho Clinical Diagnostics, creating QuidelOrtho.

Quidel and Ortho announced the definitive agreement in December 2021, with Quidel acquiring Ortho in a cash-and-stock transaction with an equity value of about $6.0 billion.9 QuidelOrtho announced completion in May 2022, saying the combination created a larger in vitro diagnostics company with more than $3.5 billion in combined 2021 revenue and about 6,000 employees.10

In its full-year 2025 results, QuidelOrtho reported total revenue of $2.73 billion. Non-respiratory revenue was $2.33 billion. Respiratory revenue was $402 million, down 20 percent due to lower COVID-19 testing, while flu revenue grew 3 percent.11

Respiratory diagnostics persisted, flu included, and COVID testing continued: QuidelOrtho reported $80.2 million in full-year 2025 COVID-19 revenue inside the respiratory segment. What ended was the emergency testing market.

The incumbents' decline tracks the end of emergency demand

A small testing company can fail for many reasons: a weak product, bad reimbursement assumptions, too little capital, operational limits, regulatory trouble. Abbott's fall in COVID testing sales has one: demand fell when the emergency use case did. QuidelOrtho's respiratory decline follows the same pattern, more concentrated.

Both companies were in diagnostics before the pandemic

That gave Abbott and Quidel an advantage over new entrants trying to build testing, distribution, quality systems, and regulatory credibility at once.

Abbott could absorb the COVID testing fall because FreeStyle Libre, medical devices, nutrition, and other diagnostics still mattered. QuidelOrtho used scale and combination to reduce dependence on a single emergency respiratory product.

In 2025 QuidelOrtho's flu tests brought in $254.6 million. Its COVID-19 tests brought in $80.2 million.11

Notes

  1. FDA, letter reissuing Sofia 2 SARS Antigen FIA EUA, noting original EUA issued May 8, 2020, original. ↩
  2. FDA, letter reissuing BinaxNOW COVID-19 Ag Card EUA, Jan. 13, 2023, noting original EUA issued Aug. 26, 2020, original. ↩
  3. Abbott, "Abbott's BinaxNOW Rapid Antigen Self Test Receives FDA Emergency Use Authorization for Asymptomatic, Over-the-Counter, Non-Prescription Multi-Test Use", Mar. 31, 2021, original. ↩
  4. Abbott Laboratories, 2021 Form 10-K, filed Feb. 18, 2022, original. ↩
  5. Abbott, "Abbott Announces Fulfillment of Federal Government Purchase of 150 Million BinaxNOW COVID-19 Rapid Tests", Jan. 12, 2021, original. ↩
  6. Abbott Laboratories, 2025 Annual Report, original; the same figures are in its 2025 Form 10-K, filed Feb. 20, 2026, original. ↩1 ↩2
  7. Quidel, "Quidel Announces Preliminary Revenue for Fourth Quarter 2021," Jan. 6, 2022, https://ir.quidelortho.com/news/news-release-details/2022/Quidel-Announces-Preliminary-Revenue-for-Fourth-Quarter-2021/default.aspx. ↩
  8. QuidelOrtho, "QuidelOrtho Receives De Novo FDA Authorization for Sofia 2 SARS Antigen+ FIA", Mar. 8, 2023, original. ↩
  9. Quidel and Ortho Clinical Diagnostics, "Quidel Corporation Signs Definitive Agreement to Acquire Ortho Clinical Diagnostics", Dec. 23, 2021, original. ↩
  10. QuidelOrtho, "QuidelOrtho Formed By The Completion Of Transaction Combining Quidel And Ortho Clinical Diagnostics", May 27, 2022, original. ↩
  11. QuidelOrtho, "QuidelOrtho Reports Fourth Quarter and Full-Year 2025 Financial Results", Feb. 11, 2026, original; filed as Ex. 99.1 to Form 8-K, original. ↩1 ↩2
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