The clinical application of molecular diagnostic technology is mainly in the form of detecting nucleic acid markers, including reagents and instruments, which are regulated by the National Medical Product Administrati..

China plans to allow the establishment of wholly foreign-owned hospitals in certain cities and regions across the country, according to an official document unveiled on Sunday.

Burning Rock Biotech and drugmaker Dizal said Thursday that they have received approval from China's National Medical Products Administration (NMPA) for a next-generation sequencing-based companion diagnostic for the lung cancer drug sunvozertinib.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has expanded its portfolio of sexually transmitted infection (STI) testing options to include the First to Know® Syphilis Test, the first over-the-counter blood test granted market authorization by the U.S. Food & Drug Administration (FDA) that can be performed by both physicians and patients.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOYTM (zolbetuximab).

Diagnostic company SphingoTec GmbH (“SphingoTec”) today announced a new partnership with Beckman Coulter Diagnostics Inc. (“Beckman Coulter”). Through this collaboration, the companies will bring an assay for SphingoTec’s innovative kidney function biomarker, Proenkephalin 119-159 (penKid), to Beckman Coulter’s extensive test menu for use on the Access Family of Immunoassay Analyzers. This alliance marks the first central laboratory license for a penKid assay and aims to significantly enhance the diagnostic capabilities for acute kidney injury (AKI) globally, by leveraging Beckman Coulter’s global installed base of instruments.

Roche on Wednesday announced that it is partnering with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) Burn and Blast Medical Countermeasures Program to develop diagnostics for traumatic brain injuries (TBI).

Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA's De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes.

Seegene Inc., a leading South Korean company providing a total solution for PCR molecular diagnostics, announced today the finalization of a partnership agreement with Werfen, a worldwide leader in specialized diagnostics, on the technology-sharing initiative. Under the agreement, Seegene and Werfen will set up a NewCo in Spain, Werfen-Seegene, upon the conclusion of mandatory government approvals anticipated by the first half of 2025.

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

Agilent Technologies Inc. (NYSE: A) today announced a new strategic partnership with the National University of Singapore (NUS), acting through the Yong Loo Lin School of Medicine (NUS Medicine), to establish the NUS-Agilent Center of Excellence (CoE) in Cell Metabolism. This scientific collaboration will advance cardiovascular and metabolic disease translational research over the next four years.

An international team has tracked the protein changes that occur in cerebrospinal fluid (CSF) during disease progression in individuals with autosomal dominant forms of Alzheimer's disease.

Diasorin (FTSE MIB: DIA) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Negative Blood Culture Assay, the second of the three molecular multiplexing panels for Blood Culture identification on the LIAISON PLEX®.

Following the passage of continuing resolutions (CR) by the US Senate and the House of Representatives this week, lab test reimbursement cuts and price reporting requirements called for under the Protecting Access to Medicare Act (PAMA) are likely to be delayed one year.