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Diagnostics Regulatory

 News Release - March 19, 2019

Abbott Announces CE Mark for Alinity(TM) m Diagnostics System and Assays, the Latest in Molecular Technology, to Help Deliver Critical Test Results and Benefits to Patients

Alinity m will allow labs to meet the growing demand for infectious disease testing by offering increased efficiency and market-leading speed and accuracy

This new technology presents one of the most significant advancements seen in the molecular diagnostics field in decades

ABBOTT PARK, Ill., March 19, 2019 -- (Healthcare Sales & Marketing Network) -- Abbott (NYSE: ABT) announced today CE Mark for its Alinity™ m diagnostics system and assays. This new technology will help keep up with the growing demand for infectious disease testing. Alinity m will provide unprecedented flexibility in molecular diagnostic testing, allowing more tests to be done in shorter timeframes, while reducing the space and number of instruments needed to conduct large amounts of tests.

"To design Alinity m, we spent countless hours with hundreds of lab directors around the world to address the challenges they face, including higher testing volumes, managing complex, labor-intensive processes and doing so with less time and space," said John Carrino, divisional vice president, research and development, Molecular Diagnostics, Abbott. "Alinity m will dramatically increase efficiency while delivering accurate results that patients and healthcare professionals can trust to help make decisions about their health and treatment."

The World Health Organization (WHO) reports that more than a billion people around the world are living with infectious diseases. For people living with infectious diseases, quick and accurate molecular test results are needed to help prevent the spread of communicable diseases globally. Advanced molecular testing also allows those living with these health conditions to be diagnosed correctly and then monitor how they respond to treatment.

"Molecular laboratories are playing an increasingly important role in providing critical test results, and we're struggling to keep up with demand," said Martin Obermeier, M.D., CEO, Medical Center for Infectious Diseases in Berlin. "Alinity m will significantly improve the way we operate laboratories by letting staff run any sample at any time, without the need to group samples, allowing us to focus on giving physicians the information they need to make accurate, timely clinical decisions."

Alinity m provides unprecedented flexibility for lab staff and faster testing results for clinicians and patients. Alinity m may also reduce the lab equipment footprint from four to six instruments down to one – decreasing the space requirements and hours spent learning and maintaining different instruments.

Now available in countries that recognize CE Mark, Alinity m offers initial assays including virologic testing for human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV); sexual health-related testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium or CT/NG/TV/MG panel; and high-risk human papillomavirus (HPV) testing.

Local product availability may vary depending on geographic location. In the U.S., Alinity m is in development and is not commercially available for diagnostic use.

About Alinity

Abbott's Alinity family of harmonized solutions is unprecedented in the diagnostics industry, working together to address the challenges of using multiple diagnostic platforms and simplifying diagnostic testing. Alinity systems are designed to be more efficient – running more tests in less space, generating test results faster and minimizing human errors – while continuing to provide quality results. The availability of the Alinity systems and tests varies by geography. More information is available at

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Connect with us at, on LinkedIn at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Source: Abbott

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