Beckman Coulter Diagnostics, a global leader in clinical diagnostics and a Danaher company, today announced it received CE Mark under IVDR for its Access p-Tau217 assay, a blood test designed to support clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline. The company also introduced its high-specificity Access BD-pTau217 Research Use Only (RUO) assay at the Alzheimer's Association International Conference (AAIC) 2026 in London.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its Shield™ blood test for colorectal cancer screening (CRC) is now covered for eligible UnitedHealth Group (UHG) members, making it the first major commercial insurer to provide coverage for adults 45 or older amid rising CRC rates for adults under 65 and mortality for younger adults as the leading cause of cancer death for those under 50.

According to the network statistics, market size of China’s blood group reagent was RMB 2.55 billion in 2024, which is expected to achieve RMB 2.86 billion in 2025 with growth rate of 12.3%.

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that its Personalis EDTA Blood Collection Kit and Personalis cfDNA Blood Collection Kit have obtained Class A CE-IVD marking in compliance with the European Union’s In Vitro Diagnostic Regulation (IVDR).

It is foreseeable that development trend of Blood typing reagent technologies is mainly reflected by improvement of Blood typing accuracy, increase in Blood typing efficiency and reduction of test time; improvement of Blood typing sensitivity and prevention of missed test; evaluation of antibody titer determination and other aspects.

At present, MGT-based blood group test card has been used extensively in the field of blood typing, and MGT boasts of easy operation, high sensitivity, accurate results that can be saved and other strengthens, which allowed it to become method recommended by American Association of Blood Banks (AABB), technique recognized by FDA and internationally recognized blood group analysis test technique.

Trend of domestic blood typing reagent patent applications can be seen from Fig. 3, number of domestic Blood typing reagent-related patent applications increased rapidly between 2014 and 2017, which reached the peak of 38 applications for the whole year of 2017.

At present, domestic blood typing reagent-related products already covered ABO blood typing, test of Rh and other irregular antibodies, and anti-human globulin test.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has received CE Mark for Elecsys® pTau217, a blood test developed in collaboration with Eli Lilly and Company and designed to measure the phosphorylated Tau (pTau) 217 protein, an indicator of amyloid pathology and a hallmark of Alzheimer’s disease. The same cutoffs (high and low) of the blood test can be used across primary and secondary care settings, to rule in or rule out amyloid pathology in people presenting with symptoms or complaints of cognitive decline. The early detection of the amyloid pathology is critical for Alzheimer’s diagnosis and treatment, as it enables individuals, families, and caregivers to understand the cause of symptoms, access appropriate care, and actively contribute to the planning of next steps.

Proportion of blood transfusion departments taken as an independent administrative unit is 45% at the moment, proportion of blood transfusion departments under management of laboratory department is 32%, proportion of blood transfusion departments taken as a professional group of laboratory department is 23%, utilization ratio of Automatic blood grouping analyzer is only 40%, while utilization ratio of manual/semi-automatic test instruments is still 60%.