The US Food and Drug Administration has issued its anticipated guidance for drug and device makers on the use of circulating tumor DNA tests in clinical trials of drugs for early-stage cancer, embracing the increasingly widespread use of these tests to genotype patients as well as their emerging value to enrich trials by identifying patients more likely to benefit from adjuvant or neoadjuvant treatment.

Devyser has received IVDR approval for its non-invasive fetal RHD screening product. This marks the first approval of a Class D product, the highest risk class under the new, comprehensive European regulation that came into force in May 2022.

The Egypt Healthcare Authority (EHA), Roche Diagnostics and Roche Pharmaceuticals have signed a memorandum of understanding (MOU) to advance digital pathology in Egypt.

Canon Medical Systems USA is proud to announce the launch of its AI-powered Automation Platform, an advanced, zero-click solution that leverages deep learning technology to streamline clinical workflows. Designed to deliver fast, actionable results, this innovative platform integrates seamlessly from scanner to clinical decision-making, empowering healthcare providers with precise tools to help with patient triage and confident treatment planning.

Suraksha Diagnostic Ltd, an integrated diagnostic chain based in Kolkata, has successfully raised ₹254 crore from anchor investors ahead of its initial public offering (IPO).

Original from: QIAGEN QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of two new tools for designing and ordering custom solutions that can be used to support microbial anal..

Original from: 360dx Hong Kong-based genomic testing firm Prenetics on Wednesday announced that its Q3 revenues rose 59 percent year over year. The firm reported revenue of $7.8 million, up..

Oxford Nanopore Technologies, the company delivering a new generation of nanopore-based molecular sensing technology, today announced a new collaboration with UK Biobank to create the world’s first comprehensive, large-scale epigenetic dataset.

QIAGEN today announced the inclusion of the QIAcuityDx digital PCR System in the Australian Register of Therapeutic Goods (ARTG). This pivotal addition to QIAGEN’s portfolio is now expanding digital PCR into clinical diagnostics, enabling labs to harness its precision and efficiency for applications in oncology and infectious diseases. The instrument and accessories are IVDR-certified.

Original from: Roche Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc. (“Poseida”, NASDAQ: PSTX), a public ..

1.4 Automatic Database Building Database building is a link to high-throughput sequencing. Manual database building is cumbersome and time-consuming; it requires multiple labs, and it is difficult to meet the re..

Agilent Technologies Inc. (NYSE: A) today announced a new organizational structure to accelerate the company's operational transformation to drive higher growth through a market-focused, customer-centric enterprise strategy. The new structure, including new leadership roles, takes effect immediately.

Original from: Agilent Fourth-quarter fiscal year 2024 · Revenue of $1.70 billion, up 0.8% reported and down 0.3% core(1) from the fourth quarter of 2023. · GAAP net income of $351 million; ..

Xcell Therapeutics is expanding the business scope of its exosome isolation and purification device, “EXODUS,” into the diagnostics market.

1.3 Automatic Nucleic Acid Extractor Paraffin Sample With a large number of tumor-targeted drugs on the market, companion diagnosis is increasingly used in the process of tumor treatment. The results of using ti..

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* test.

Artificial intelligence continues to reshape healthcare, but a new study highlights the challenges of integrating AI tools into medical practice. ChatGPT-4, an AI chatbot developed by OpenAI, outperformed doctors in a diagnostic accuracy study, raising questions about how effectively physicians can use such technology.

Sheba Medical Center’s innovation arm, Accelerate, Redesign, and Collaborate (ARC), has partnered with Roche to advance the diagnosis and treatment of non-small cell lung cancer (NSCLC) by leveraging AI.

NMPA，Medical Device，Pharmaceutical

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced updates to its agreement with Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies.