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30
4 进行中
药物批准
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监管机构
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进行中（未招募）
4
13.3%
已完成
19
63.3%
暂停
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3.3%
终止
3
10.0%
Unknown
2
6.7%
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3.3%
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- The 2026 Scientists' Choice Awards were announced at the ADLM Clinical Lab Expo, recognizing the most impactful clinical diagnostics innovations of 2025. - Thermo Fisher Scientific's Oncomine Dx Express Test won Best New Clinical Diagnostics Kit or Assay for advancing precision diagnostics and delivering timely, actionable results. - Mindray's FA-N Series Fully Automated Microbial Culture System won Best New Clinical Diagnostics Instrumentation for enhancing microbiology workflow productivity and operational efficiency. - Siemens Healthineers won Clinical CE Webinar of the Year, while Danaher received the Innovation in Thought Leadership award for educational content and industry insights.
- The global bone densitometers market is projected to grow from USD 391.3 million in 2026 to USD 584.8 million by 2036 at a 4.1% CAGR, according to FMI Research. - DXA systems remain the clinical gold standard, accounting for 63.0% of total market demand in 2026, while hospitals dominate end-user share at 56.0%. - Growth is increasingly driven by value-based healthcare adoption, preventive osteoporosis screening, and hospital modernization initiatives rather than new installation volume alone. - Procurement strategies are shifting toward enterprise imaging integration, with hospitals prioritizing interoperability, cybersecurity, predictive maintenance, and long-term lifecycle value over hardware specifications.
- The FDA has warned of a nationwide shortage of stereotactic breast biopsy needles expected to last until March 2027 due to a Hologic recall of its Brevera 9 Gauge Needle over contamination risks. - Hologic initiated the recall in January 2026 after reports of metal and plastic particles dislodging from needles, with 108 complaints identified among nearly 700,000 devices reviewed over three years. - The American College of Radiology has described the shortage as creating "immediate and substantial challenges" that represent a "patient safety and public health concern," particularly at high-volume and safety-net institutions. - The FDA recommends conservation strategies including vendor diversification, use of alternative needle gauges, prior-generation devices, and transparent communication with patients about diagnostic delays.
- The global molecular diagnostics market is projected to grow from USD 19.48 billion in 2025 to USD 30.74 billion by 2030, at a CAGR of 9.6%, according to MarketsandMarkets. - PCR and real-time PCR technologies dominate the market with a 42.54% revenue share, while sequencing-based testing is the fastest-growing segment due to personalized medicine adoption. - North America leads the global market with a 38.49% share, while Asia Pacific is the fastest-growing region with an estimated CAGR of 24.45% through 2035. - Key players including Roche, Danaher, Abbott, and Thermo Fisher are investing in automation, AI-powered analytics, and multiplex assay development to strengthen competitive positioning.
- New data from the BCI Registry Study shows physician recommendations for extended endocrine therapy increased by more than 30% among patients identified as likely to benefit from the Breast Cancer Index Test. - Among patients identified as unlikely to benefit from extended therapy, physician recommendations decreased by nearly 40%, demonstrating the test's ability to guide personalized treatment decisions. - The Breast Cancer Index Test is the only genomic assay with exclusive guideline recognition from NCCN and ASCO for extended endocrine therapy decision-making in hormone receptor-positive breast cancer. - Overall treatment recommendations shifted significantly, with the percentage of patients recommended for extended therapy decreasing from 54.6% to 41.2% after BCI testing.
- OM1's AI-enabled platform supported one of the largest real-world evidence studies ever conducted for an FDA submission, spanning more than 650,000 women across multiple U.S. health systems for Hologic's Aptima HPV Assay approval. - The platform automated data processing from electronic health records and laboratory systems, using AI and machine learning to extract key variables from unstructured clinical notes, cytology reports, and pathology records at unprecedented scale. - The study achieved an exceptional site Net Promoter Score of 87.5, demonstrating how automation can significantly reduce manual effort while maintaining data quality for regulatory submissions. - This approval represents a significant milestone for real-world evidence in regulatory decision-making, proving that AI-powered automation can overcome traditional constraints of cost and time in large-scale clinical data collection.
- Hologic's Aptima HPV Assay received FDA approval for clinician-collected HPV primary screening, marking the only FDA-approved mRNA-based assay designed to detect infections most likely to lead to cervical cancer. - The approval was supported by one of the largest real-world evidence HPV screening studies involving over 650,000 women across multiple U.S. health systems, demonstrating clinical comparability to DNA-based HPV tests. - The expanded approval provides healthcare providers with three major FDA-approved cervical cancer screening options: Pap + HPV co-testing, Pap testing, and HPV primary testing. - With approximately 13,490 new invasive cervical cancer cases and 4,200 deaths expected in the U.S. in 2026, the additional screening option aims to improve early detection and prevention of preventable deaths.
- Eleven studies featuring the Breast Cancer Index (BCI) Test will be presented at the 2025 San Antonio Breast Cancer Symposium, exploring expanded utility in premenopausal women with early-stage hormone receptor-positive breast cancer. - A key study demonstrates the BCI Test's potential to identify premenopausal patients at minimal risk of metastatic recurrence who may safely forgo ovarian function suppression therapy. - The research includes translational analysis of two major ovarian function suppression trials (SOFT and TEXT) and comparative analyses with the 21-gene assay for treatment decision-making. - These findings could advance personalized medicine by allowing clinicians to tailor therapies to individual patient needs while minimizing unnecessary side effects in younger breast cancer patients.
- Hologic received FDA 510(k) clearance and European CE marking for its Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays, marking the company's entry into GI pathogen diagnostics. - The molecular tests rapidly detect common bacterial pathogens causing infectious gastroenteritis, including Salmonella, Campylobacter, Shigella, E. coli, Vibrio, Yersinia and Plesiomonas, addressing a significant healthcare burden with nearly 200 million annual US cases. - The customizable mini-panel format allows laboratories to run tests individually or in combination, reducing labor-intensive traditional culture methods while supporting faster diagnosis and antimicrobial stewardship. - The assays integrate with Hologic's established Panther Fusion System platform, expanding the company's molecular diagnostics menu beyond women's health and sexually transmitted infections into infectious gastroenteritis testing.
- Mercy BioAnalytics closed a $59 million Series B financing round co-led by Novalis and Sozo Ventures to advance its extracellular vesicle-based liquid biopsy platform for early cancer detection. - The company's Mercy Halo ovarian cancer screening test demonstrates unprecedented sensitivity and specificity for detecting pre-clinical high grade serous ovarian carcinoma in post-menopausal women. - Funding will support commercialization of the blood-based ovarian cancer test portfolio and expansion into multi-cancer and lung cancer screening applications. - Strategic investors including Hologic, Bruker Scientific, and Labcorp participated in the round, highlighting industry confidence in the platform's commercial potential.
