North America Nucleic Acid Amplification Testing Market Size, Share, Growth, Trends, Industry Analysis & Forecast 2026–2034

2. Cepheid – Xpert Carba-R

Cepheid's Xpert Carba-R is a multiplex nucleic acid amplification test designed to identify major carbapenemase genes associated with antimicrobial-resistant Enterobacterales. The FDA cleared the test in July 2026.

3. Abbott – Alinity m HIV-1 AMP Kit

Abbott's Alinity m HIV-1 AMP Kit received FDA clearance in August 2025 for use with the Alinity m molecular diagnostic system, expanding automated HIV-1 testing capabilities.

4. Abbott – Alinity m HCV

The Alinity m HCV assay detects hepatitis C virus RNA. It received FDA 510(k) clearance on September 25, 2025.

5. DiaSorin Molecular – LIAISON NES FLU A/B, RSV & COVID-19

This multiplex respiratory nucleic acid test detects influenza A/B, RSV, and SARS-CoV-2. Its FDA clearance in December 2025 supports expanded respiratory pathogen testing.

6. QIAGEN – QIAstat-Dx Respiratory Panel Plus/Mini

QIAGEN received FDA clearance in August 2025 for its QIAstat-Dx Respiratory Panel Plus and Mini systems, which support multiplex molecular detection of respiratory pathogens.

7. Roche – cobas HIV-1/HIV-2 Qualitative Nucleic Acid Test

The qualitative HIV-1/HIV-2 molecular assay received FDA clearance in June 2025 for use with Roche's cobas 5800/6800/8800 platforms.

8. Roche – cobas HIV-1 Quantitative Nucleic Acid Test

Roche received FDA clearance in July 2025 for its quantitative HIV-1 nucleic acid test, supporting molecular measurement of HIV-1.

9. Roche – cobas liat SARS-CoV-2 v2 Nucleic Acid Test

This point-of-care molecular diagnostic solution received FDA 510(k) clearance in April 2025 and supports near-patient SARS-CoV-2 testing.

10. Hologic/Gen-Probe – APTIMA HPV Assay

The APTIMA HPV Assay detects E6/E7 messenger RNA from 14 high-risk HPV types in cervical specimens. An FDA PMA supplement was approved in February 2026.

Country Analysis of the North America NAAT Market

United States Nucleic Acid Amplification Testing Market

The United States represents the dominant market for nucleic acid amplification testing in North America. Its advanced healthcare infrastructure, extensive laboratory networks, established biotechnology ecosystem, and high adoption of molecular diagnostics support market development.

Infectious disease testing remains a major application, while the use of NAAT is expanding into oncology, genetic testing, and precision medicine.

The presence of leading diagnostic manufacturers, including Roche, Abbott, Danaher, and other biotechnology companies, supports continuous innovation in automated, multiplex, and point-of-care molecular testing.

Government investment in infectious disease surveillance, laboratory preparedness, and healthcare modernization further contributes to market expansion.