近期，IVD行业的AI概念股表现强势。安必平、迪安、华大、三诺、万孚、润达、金域、塞力医疗等多家IVD企业股价大幅上涨。 这一轮强势表现离不开 ...

The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s ...

Critically, the Final Rule ended FDA’s longstanding policy of not actively regulating LDTs pursuant to its enforcement discretion (although the agency has long maintained it can regulate LDTs in the ...

本报告对过去五年IVD（体外诊断）产品市场的规模和增长率进行了全面统计，并预测了未来的发展前景。数据显示，2024年全球和中国IVD（体外诊断）产品市场规模分别达到 亿元和 亿元。基于市场增长模式，报告预测全球IVD（体外诊断）产品市场将在2030年达到 ...

While the U.S. Supreme Court sidelined itself over patent issues such as subject matter eligibility, the diagnostic patent wars are still in full swing as a casual review of cases at the U.S. Patent ...

As the global burden of disease caused by multidrug resistant bacteria is a major source of concern, credible clinical alternatives to antibiotic therapy, such as personalized phage therapy, are ...

Making an in vitro diagnostic assay has never been easy. Now with the global lab and supply chain and disruptions caused by the COVID pandemic, the development and manufacture of IVDs faces further ...

The miRpredX-31-3p kit (IntegraGen S.A., France) is a CE-IVD marked theranostic test intended to identify patients with metastatic CRC who can benefit from anti-EGFR (epidermal growth factor receptor) ...