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.

H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Fujirebio Europe N.V. has obtained a CE certificate of the Lumipulse G pTau 217 Plasma assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This CLEIA (chemiluminescent enzyme immunoassay) test allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K2EDTA).

Lucent Diagnostics, a brand of Quanterix Corporation (NASDAQ: QTRX), today announced a collaboration with Tempus AI Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, to broaden access to a novel blood-based biomarker panel designed to improve detection accuracy for Alzheimer’s disease. Through the agreement, Tempus AI will build a Tempus Next care gap program for Alzheimer’s disease blood-based biomarker testing, with the LucentAD® Complete multi-biomarker blood test becoming available for neurologists to order on the Tempus clinical ordering platform.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

BGI Genomics (300676.SZ), opens new tab and Roche Diagnostics (ROG.S), opens new tab have rolled out tests for Alzheimer's disease in China, the companies said, in an effort to expand access to easier-to-use diagnosis and monitoring choices for patients with the brain-wasting condition.

Altoida, Inc., a pioneer in AI- and AR-powered digital diagnostics for neurological diseases, today announced a research collaboration with Mindspan, the cognitive care company focused on changing the trajectory of decline for patients with Alzheimer's disease and related conditions. Together, the companies will conduct an investigational pilot study evaluating the clinical, operational, and potential economic impacts of integrating Altoida’s rapid, AI/AR-powered digital NeuroMarker platform into Mindspan’s innovative cognitive care delivery model.

Roche Diagnostics’ Elecsys® Alzheimer’s disease (AD) cerebrospinal fluid (CSF) test panel has received approval from the National Medical Products Administration (NMPA) for market launch in China.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

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.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection of the amyloid plaques associated with the disease in appropriate patients. Developed by Fujirebio Diagnostics, Inc., the test is now available nationwide through Labcorp.