Against the background of an increasingly aging global population, the incidence of thrombotic and hemostatic diseases, including cardiovascular diseases, remains high.

Presently, the domestic IVD market shows a slow overall growth rate, but with the emergence of new projects, the improvement of industry concentration, and the emergence of assembly line trends, etc., the blood coagulation market will become thriving.

According to basic survey results, the existing main problems for coagulation testing include nonunified standardization, insufficient academic knowledge of blood coagulation, less equipment, few testing items, insufficient sample size, insufficient clinical communication, etc.

Implementation of in Vitro Diagnosis of Thrombosis and Hemostasis in the Chinese Market

With the development of the blood coagulation industry, more and more IVD companies have joined it and actively expanded the related services.

In terms of the domestic IVD markets of hemostasis and thrombosis, the special testing items are gradually promoted and popularized in domestic medical institutions.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (FDA) has cleared its Elecsys pTau181 test, the only blood-based biomarker (BBM) test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting. The Elecsys pTau181 test is intended for patients ages 55 and older presenting with signs, symptoms or complaints of cognitive decline. It measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer’s pathology, including amyloid plaque and tau aggregate pathology.

The routine four items are usually used for preoperative examination, but they cannot specifically determine the cause of thrombosis and bleeding in patients.

At present, the coagulation tests are mainly applied for the screening of thrombotic diseases and hemorrhagic diseases, and the routine six items are relatively common in clinical practice (Table 3), mainly including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), D-dimer (D-D), and fibrin (pro) degradation products (FDP).

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced a broad strategic collaboration to make Guardant’s Shield™ blood-based screening test available to physicians and patients served by Quest in the United States.