Molecular diagnosis refers to the technique of using molecular biological methods to detect changes in the structure or expression level of genetic material in patients to make a diagnosis.

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.