Devyser’s novel test for detecting donor-derived cell-free DNA in blood samples from kidney-transplant patients and its product for screening and follow-up of stem cell transplant patients fulfill IVDR requirements in Europe.

Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced a new partnership combining their respective immunoassay strengths to support therapeutic development, clinical trials, reimbursement, and routine clinical adoption in the field of neurodegenerative diseases.

On the evening of July 12, Zhejiang Orient Gene Biotech Co., Ltd announced that its wholly owned subsidiary, Shanghai Wanzi Health Medical Laboratory Co., Ltd., had obtained medical device registration certificates for carcinoembryonic antigen, neuron-specific enolase, and cytokeratin 19 fragment detection kit (flow fluorescence luminescence method).

A partnership between Quest Diagnostics and Envision Sciences has introduced a new prostate cancer biomarker test.

To address challenges with error-prone, manual molecular testing workflows, Thermo Fisher Scientific today has introduced Diomni Enterprise Software, helping streamline routine diagnostics testing for standardization and faster time-to-results. By connecting workflow steps within one interface, Diomni Enterprise can increase a lab’s ability to dynamically respond to today’s rapidly changing testing environment. The solution can be used by a variety of labs performing routine quantitative polymerase chain reaction (qPCR) diagnostic tests and by developers to increase the speed of innovation for emerging testing solutions.

Recently, Ustar and Hangzhou Biotest Biotech received the IVDR CE certificate from TÜV SÜD, a notified body designated under the EU's IVDR.

Fortis Life Sciences on Wednesday said it has acquired diagnostic testing component maker International Point of Care.

Tempus, a leader in artificial intelligence and precision medicine, announces its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery.

On July 10, 2023, NMPA released information on the delivery of medical device approval certification documents.

Prenosis on Wednesday said it will use $4.8 million from two Small Business Innovation Research (SBIR) grants from the National Institutes of Health's National Institute of General Medical Sciences (NIGMS) to study why patients develop sepsis in acute care settings and how best to treat them using its Immunix Artificial Intelligence platform.

Alveo Technologies said on Tuesday that it has partnered with Germany's Fraunhofer Institute for Cell Therapy and Immunology IZI to develop molecular diagnostic tests for the veterinary space.

On July 5th, the State Council Information Office held a series of press conferences covering the review and approval of medical devices, medical device regulation, innovative medical devices and other industry issues of concern.

Quest Diagnostics (NYSE: DGX), the leader in diagnostic information services, today announced the launch of its first consumer-initiated genetic test, now exclusively available through the company's consumer health business at questhealth.com. Called Genetic Insights, the new offering helps people understand their potential risk of developing certain inheritable health conditions, with advanced technology and end-to-end support that includes personalized health reports and access to genetic counseling.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced that it has entered into an agreement with Legacy Health to acquire select assets of its outreach laboratory business, including laboratory facilities and equipment. Labcorp will also manage Legacy's inpatient hospital laboratories through a long-term agreement to provide staffing, leadership, scientific knowledge, analytics, supply chain services and laboratory support.

Owing to the aging population, increasing awareness of disease management, and continuous technological advancements, the global in vitro diagnostic reagents market is expected to grow from USD 69.25 billion in 2019 to USD 90.65 billion by 2023, with a CAGR of 6.2%.

Researchers have determined that a liquid biopsy human papillomavirus DNA test may serve as a useful tool for the diagnosis and surveillance of HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).

Agilent Technologies Inc. (NYSE: A) today announced the company has achieved certification as a Great Place to Work®. The recognition reflects Agilent's commitment to creating a positive work environment that fosters employee engagement, innovation, teamwork and professional growth.

Beijing Hotgen Biotech Co., Ltd（688068.SH）released an announcement on July 6, the company intends to use its own funds together with Qingdao Chuangjing Private Equity Fund Management Co., Hangzhou Bioer Technology Co.,Ltd, Anhui Yaoan Investment Group Co. and Shaoxing Guochuang Zhende Medical (603301) Industry Phase I Equity Investment Partnership (Limited Partnership) co-finance and participate in the investment in Tristar Conrad.

Quest Diagnostics said Thursday that women seeking to start or expand a family can now access the Proov Confirm PdG home collection kit for assessing fertility through questhealth.com.

Diagnostics company Novacyt UK has agreed to purchase UK-based genomic medicine company Yourgene Health in a £16.7m ($21.3m) deal.