Mesa Biotech

Mesa Biotech, Inc. operated as a molecular diagnostic company, specializing in the development of PCR-based testing platforms for infectious diseases at the point-of-care (POC).

The company was founded in 2009 by Dr. Hong Cai and Dr. Bruce Cary, who initiated their work at Los Alamos National Laboratory. Their journey began in response to the SARS-CoV-1 outbreak in 2003, with the goal of creating a field-deployable diagnostic test for pandemic preparedness. Dr. Cai, who served as co-founder and CEO, has over two decades of experience in molecular biology and is credited as the inventor of the technology utilized in Mesa Biotech's platform. Her background includes 13 years as a principal investigator at Los Alamos National Laboratory, where she led projects on nucleic acid-based assays for various applications, including biothreat pathogen detection and human disease diagnosis. The company was originally established in New Mexico and later relocated to San Diego to leverage its more established life sciences environment.

Mesa Biotech's core business centered on its Accula™ System, a portable, palm-sized dock with disposable, assay-specific test cassettes. This system was designed to provide laboratory-quality results with high sensitivity and specificity directly to healthcare professionals in various settings, including physician offices, pharmacies, and clinics. The Accula platform integrates nucleic acid extraction, PCR amplification, and visual detection into an automated, self-contained device, delivering results within 30 minutes. The business model focused on selling this low-cost-entry system and the accompanying disposable test cassettes for various infectious diseases. By 2020, the company had grown to approximately 500 employees and reported revenues of around $45 million.

The company's product portfolio included tests for Influenza A/B, Respiratory Syncytial Virus (RSV), and Strep A, which had received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waivers from the FDA. A significant milestone was achieved when the Accula SARS-CoV-2 test received FDA Emergency Use Authorization (EUA) in March 2020, becoming one of the first rapid PCR tests available during the early stages of the COVID-19 pandemic. This pivotal development led to a major achievement for the company: its acquisition by Thermo Fisher Scientific. The deal, announced in January 2021 and completed in February 2021, was for approximately $450 million in cash, with an additional $100 million contingent on certain milestones. Following the acquisition, Mesa Biotech was integrated into Thermo Fisher's Life Sciences Solutions Segment.

Keywords: point-of-care diagnostics, molecular diagnostics, PCR testing, infectious disease testing, Accula System, rapid diagnostics, Thermo Fisher Scientific, Hong Cai, Bruce Cary, Los Alamos National Laboratory, SARS-CoV-2 testing, Influenza testing, RSV testing, Strep A testing, CLIA waiver, diagnostic equipment, pandemic preparedness, microfluidics, nucleic acid amplification, lab-on-a-chip