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%.

According to network data analysis, market size of China’s blood grouping analyzer was RMB 1.704 billion in 2024, and it is predicted to achieve RMB 1.89 billion in 2025.

Integrated pipeline: high speed and high throughput instrument’s rigid demand of high-end hospitals and laboratories will develop towards the direction of integrated pipeline to meet high-end hospitals’ test requirements.

It can be seen from analysis on major blood grouping analyzer-related patent applications published in the 3 years from 2018 to 2021 that benefited from the basically stable original technologies of the industry; domestic enterprises have continuously increased R&D inputs, constantly improved technical innovation capability, made breakthroughs in many technologies, and developed a batch of core components of instruments with independent intellectual property rights through follow-on R&D strategy.