From January 2024 and June 2025, the U.S. Food and Drug Administration (FDA) approved 39 in-vitro toxicology testing products through the 510(k). This period marked a significant reshaping of the global market: Chinese companies, driven by rapid product iteration and precise market positioning, surged in the market share. At the same time, the worsening fentanyl crisis in the U.S. fueled an unprecedented demand for fentanyl testing, making it the most competitive and dynamic segment in the field.

Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for bleeding disorders and diagnosis of bleeding origins, with a relatively narrow scope of application and relatively poor accuracy.

Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek™ for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. MI Cancer Seek is available for adults and pediatric patients, ages 1-22.

Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), today provided a business update for the Company and presented financial results for the three months ended September 30, 2024.

Chinese authorities recently released revised rules on foreign investors' strategic investment in listed companies in a move to encourage foreign investors to make long-term and value investments in the country.

Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO), through its subsidiary Life Technologies Corporation (“Thermo Fisher”), a world leader in supplying life sciences solutions and services.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the third quarter ended September 30, 2024.

The following innovative products have obtained the registration certificate of regulatory authorities for the first time in the industry based on the technology platform, and are open to the whole market as the benchmark. Only some representative products are listed.

The Board of Directors of Diasorin S.p.A. (FTSE MIB: DIA), examined and approved the Group’s Consolidated Financial Statements at September 30, 2024.

Siemens Healthineers AG today announces its results for the fourth quarter of fiscal year 2024 ended September 30, 2024, and the full fiscal year 2024.

Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the third quarter ended September 30, 2024.

On November 8, 2024, Roche Diagnostics enhanced the company's long term commitment to China's local healthcare industry, to ultimately benefit patients in China and beyond, with the opening of its new Roche Diagnostics Head Office in China.