Point-of-Care drugs of abuse testing is estimated at $576 million and is anticipated to grow at 2.4% over the next five years.

The TOBY Test has received breakthrough device designation from the FDA for the early detection of bladder cancer. This designation underscores the significant potential of this innovative urine-based assay to fundamentally alter the landscape of bladder cancer detection and surveillance, offering a much-needed non-invasive alternative to current diagnostic paradigms.

PHASE Scientific International Limited ("PHASE Scientific"), a pioneering biotechnology company revolutionizing early disease detection through proprietary urine-based diagnostics, today announced the successful completion of a US$34 million Series A funding round. This represents the largest Series A raise in Asia’s diagnostic technology sector since 2019, reflecting robust investor conviction in PHASE Scientific’s innovative PHASIFY™ technology and ambitious growth strategy. The funding round is led by a private equity fund managed by Value Partners Group (HKEX: 0806), one of Asia's largest independent asset management firms, with significant backing from new healthcare-focused investors and continued support from existing global backers.

Copan Diagnostics, a leader in microbiology laboratory innovations, is proud to announce that UriSponge®, a urine collection and transport device which uses a new formulation of advanced preservatives to ensure specimen stability for culture, has received clearance from the U.S. Food and Drug Administration (FDA). The solution offers clinical laboratories and healthcare providers a user-friendly, reliable, and cost-effective way to improve urine specimen collection, preservation, and transport.

PreAnalytiX GmbH, a joint venture between QIAGEN N.V. (NYSE: QGEN; Frankfurt, Prime Standard: QIA) and BD (Becton, Dickinson and Company; NYSE: BDX), today announced the launch of the PAXgene® Urine Liquid Biopsy Set, which enables the reliable analysis of cell-free DNA (cfDNA) from urine with most molecular testing technologies, including qPCR, digital PCR and next-generation sequencing (NGS). The new set will be commercialized by QIAGEN.

Astek Diagnostics and Key Technologies announced on Tuesday that they have partnered to develop a benchtop analyzer that will be used to diagnose urinary tract infections.

In a new study looking at the long-term effects of hospitalized patients who have acute kidney injury, Johns Hopkins Medicine researchers found that higher levels of certain biomarkers in urine and blood can predict a patient’s risk of developing chronic kidney disease.

Recently, Shenzhen Superbio Technology Co., Ltd. Fentanyl Drug Abuse Detection Kit (fluorescence chromatography method) has obtained 510 (k) pre-market notification, which is the world's first POCT product approved by the US FDA for the detection of fentanyl by fluorescence method.