The US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq.

Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced it has signed an agreement with Janssen Research & Development, LLC (Janssen). This collaboration will be the first relating to the development of Illumina's novel molecular residual disease (MRD) assay, a whole-genome sequencing (WGS) multi-cancer research solution that detects circulating tumor DNA (ctDNA) to better understand the persistence or recurrence of disease following clinical intervention.

OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced it is leading the Series B financing and has entered wide-ranging strategic distribution agreements with Sapphiros, a privately held consumer diagnostics portfolio company based in Boston, and certain of its related entities. Sapphiros was conceived in 2020 by experienced healthcare executive Namal Nawana and launched along with leading global investment firm KKR in 2021. The company has since developed innovative capabilities including novel sample collection, next-generation detection systems, computational biology, and printed electronics to help consumers access diagnostic results.

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the ¡°Company¡± or ¡°Burning Rock¡±), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that it has received written notification from the staff of the Listing Qualifications Department of the Nasdaq Stock Market LLC (¡°NASDAQ¡±) dated December 29, 2023, indicating that for the last 30 consecutive business days, the closing bid price for the Company¡¯s American depositary shares (the ¡°ADSs¡±) was below the minimum bid price of US$1.00 per share requirement set forth in NASDAQ Listing Rule 5450(a)(1). The NASDAQ notification letter has no current effect on the listing or trading of the Company¡¯s securities on NASDAQ.

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.