Haemonetics Welcomes New FDA Guidance on Viscoelastic Testing During COVID-19 Pandemic

BOSTON, Jan. 22, 2021

Haemonetics' TEG® 5000 and TEG® 6s hemostasis analyzers provide market leading viscoelastic tests. TEG® analyzers use whole blood, including platelets, and provide functional insights into the entire blood clotting process. For this reason, viscoelastic testing, such as the TEG® technology, has been recognized by the FDA as a potential adjunctive diagnostic to help better characterize COVID-19 associated coagulopathy (CAC) and to inform patient management, including personalized anticoagulation to reduce the risk of bleeding.

CAC is characterized by hypercoagulability resulting from increased blood clot formation and impaired fibrinolysis, or the body's ability to resolve blood clots. This condition is common among COVID -19 patients and can lead to potentially deadly complications, such as venous thromboembolism, pulmonary embolism or stroke.

"While leading symptoms of COVID-19 include fever, cough and shortness of breath, it has become apparent that blood coagulation and clotting issues play a critical role in this disease," said Jan Hartmann, MD, Haemonetics' VP Medical Affairs, Clinical Development & Medical Safety.

"COVID-19 is a healthcare and humanitarian crisis of unprecedented dimensions," said Stewart Strong, Haemonetics' President, Global Hospital. "As a market leader, we have worked closely with our partners at hospitals across the country to provide our support with tools to optimize use of scarce blood resources. We remain committed to making our innovative technologies available to healthcare professionals at the front line of fighting this pandemic."

About Viscoelastic Testing
Viscoelastic testing is used to analyze the ability of patients to form blood clots and to resolve them, and it provides holistic and unique insights beyond the information gained from conventional coagulation tests that each only look at one step in this process. This unique testing reviews the entire process, from the activation of the coagulation to the clot formation and ultimately to its resolution. In addition, viscoelastic testing uses whole blood from patients, as opposed to platelet-poor plasma like conventional tests, so it can provide more and valuable information, including about the contribution of platelets.