Haemonetics Says Supports FDA Guidance On Viscoelastic Testing During COVID-19 Pandemic

(RTTNews) - Haemonetics Corp. (HAE) said Friday it supports new guidance issued by the U.S. Food and Drug Administration or FDA related to the use of viscoelastic testing for the duration of the public health emergency related to COVID-19.

Viscoelastic testing is used to analyze the ability of patients to form blood clots and to resolve them. It provides holistic and unique insights beyond the information gained from conventional coagulation tests that each only look at one step in this process.

Haemonetics said it is working expeditiously to fulfil the requirements to modify the indications for the TEG 5000 and TEG 6s hemostasis analyzers and all related assays by amending product labeling and instructions for use, in line with the FDA guidance. The company noted this will allow healthcare professionals to begin using TEG products for improved patient care during the pandemic.

Haemonetics' TEG 5000 and TEG 6s hemostasis analyzers provide viscoelastic tests. TEG analyzers use whole blood, including platelets, and provide functional insights into the entire blood clotting process.

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 or 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, common among COVID-19 patients, can lead to potentially deadly complications such as venous thromboembolism, pulmonary embolism or stroke.