Molecular diagnostic firm T2 Biosystems announced Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration to expand the use of its T2Candida Panel for pediatric testing.

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has formalized an exclusive distribution agreement with Aptitude Medical Systems (Aptitude™), an innovative developer of decentralized molecular diagnostics, to sell the Aptitude MetrixTM COVID-19 Test in the U.S. The Metrix test is currently the only EUA approved, molecular test which can be used with both swab and saliva samples and can performed by healthcare professionals or at home by consumers.

As of August 2023, the top three provinces in terms of the number of medical device manufacturers are Guangdong, Shandong and Hebei, with Guangdong ranking first with 8,493 medical device manufacturers. Chongqing has a total of 756 medical device manufacturing enterprises, ranking 19th in China.

UK-based liquid biopsy firm Angle said Tuesday that it inked an agreement with drug firm Eisai to conduct a pilot study on the use of Angle's HER2 assay to guide treatment of breast cancer patients with HER2-expressing solid tumors.

Roche Holding AG will fold its stand-alone diabetes business into its broader diagnostics unit after a decade and a half of declining sales.

There are multiple classification criteria for immunodiagnostic techniques, the most commonly used of which are classified into labeled immunoassays and non-labeled immunoassays according to whether they are labeled or not.

Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime¡¯s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.

Swiss drugmaker Roche (ROG.S) said on Friday it has agreed to buy LumiraDx's (LMDX.O) Point of Care diagnostics platform business for about $295 million.

In 2023, China Chamber of Commerce of Medical & Health Products Importers & Exporters (CCCMHPIE) successively announced three batches of export brand certificates for companies recommended by CCCMHPIE in FY2023.

Bruker has entered into an agreement with private equity firm PAI Partners to purchase EliTechGroup, PAI announced on Wednesday.

Eli Lilly and Company (NYSE: LLY) today announced the successful completion of its acquisition of POINT Biopharma Global Inc. (NASDAQ: PNT), a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer.

Up to now, the total number of domestic Class II & III medical device product registrations within the validity period in China has reached 114,626.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

By rapid development of China's immunoassay, the market share of chemiluminescence has gradually expanded. Immunoassay diagnosis was already the largest sub-field of the market in China, currently accounting for about 25%.

The Egyptian Drug Authority (EDA) and Roche, global leader in pharmaceuticals and diagnostic solutions have signed a Memorandum of Understanding (MOU) to shape the regulatory environment and undergo digital transformation.

H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.

Virax Biolabs said on Thursday that it has formed an alliance with the University of Manchester and Northern Care Alliance Foundation Trust, a member organization of the UK's National Health Service, to investigate T-cell responses in long COVID-19 patients.

Enable Biosciences said on Tuesday that it has received a $3 million Phase IIB Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases for its type 1 diabetes test.

The US Food and Drug Administration announced on Tuesday that it has approved AutoGenomics' test to determine whether a patient has an elevated risk of developing opioid use disorder (OUD).

QuidelOrtho Corporation (Nasdaq: QDEL) (¡°QuidelOrtho¡±), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients.