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Sysmex Inostics Achieves CAP Accreditation and ISO 15189 Certification, Enhancing Quality Standards in Diagnostic Excellence

Sysmex Inostics Achieves CAP Accreditation and ISO 15189 Certification, Enhancing Quality Standards in Diagnostic Excellence

Sysmex Inostics 获得 CAP 认证和 ISO 15189 认证,提升了诊断卓越的质量标准。
PR Newswire ·  2024/12/10 13:15

BALTIMORE, Dec. 10, 2024 /PRNewswire/ -- Sysmex Inostics, a global leader in innovative liquid biopsy solutions, proudly announces its recent accreditation by the College of American Pathologists (CAP) as well as its certification under ISO 15189 standards. These prestigious recognitions reaffirm Sysmex Inostics' commitment to delivering the highest level of quality and reliability in its clinical diagnostics and laboratory services.

巴尔的摩,2024年12月10日 /PRNewswire/ -- Sysmex Inostics,全球领先的创新液体活检解决方案提供商,自豪地宣布其最近获得了美国病理学家协会(CAP)的认证以及ISO 15189标准下的认证。这些有声望的认可重申了Sysmex Inostics致力于在其临床诊断和实验室服务中提供最高水平的质量和可靠性。

CAP accreditation, considered the gold standard in laboratory quality assurance, signifies that Sysmex Inostics has met or exceeded rigorous industry standards for accuracy, precision, and patient safety. The ISO 15189 certification further underscores the laboratory's dedication to quality management and technical competence, ensuring the reliability and integrity of test results that support critical healthcare decisions.

CAP认证被视为实验室质量保证的金标准,意味着Sysmex Inostics已经满足或超过了严格的行业标准,确保精确性、准确性和患者安全。ISO 15189认证进一步强调了实验室对质量管理和技术能力的承诺,确保了支持重要医疗决策的测试结果的可靠性和完整性。

"Achieving both CAP accreditation and ISO 15189 certification represents a significant milestone in our commitment to delivering diagnostic excellence," said Aaron J. Lizee, Vice President, Commercial Operations of Sysmex Inostics. "These accomplishments reflect the hard work and dedication of our team and demonstrate our unwavering focus on quality and patient outcomes."

"获得CAP认证和ISO 15189认证是我们致力于提供诊断卓越的重大里程碑," Sysmex Inostics商业运营副总裁Aaron J. Lizee表示。"这些成就反映了我们团队的辛勤工作和奉献精神,展示了我们对质量和患者结果的坚定关注。"

The addition of CAP and ISO 15189 to the Sysmex Inostics quality system strengthens the laboratory's ability to meet international standards and ensures a robust framework for continuous improvement. These accreditations provide confidence to clinicians, researchers, and partners by reinforcing the accuracy and reproducibility of results across a wide range of diagnostic applications.

CAP和ISO 15189的加入增强了Sysmex Inostics质量体系,使实验室能够满足国际标准,并确保一个持续改进的坚实框架。这些认证为临床医生、研究人员和合作伙伴提供信心,通过强化各种诊断应用中结果的准确性和可重复性。

"Our enhanced quality system empowers us to meet the highest regulatory and operational standards," added Takeisha Wright, Sr. Director, Regulatory Affairs and Quality Assurance. "This achievement is not just about compliance; it is about setting the bar for excellence in diagnostics and ensuring our clients and patients receive the most reliable data to guide life-saving decisions."

"我们增强的质量体系使我们能够达到最高的监管和操作标准," 监管事务与质量保证高级董事Takeisha Wright补充道。"这一成就不仅仅是关于合规;它是关于为诊断卓越设立标准,确保我们的客户和患者获得最可靠的数据,以指导救生决策。"

By integrating these accreditations into its quality system, Sysmex Inostics solidifies its position as a trusted partner in advancing precision medicine, supporting innovations in oncology, and delivering diagnostic solutions that improve patient care worldwide.

通过将这些认证整合到其质量体系中,Sysmex Inostics巩固了其作为推进精准医疗的可信赖伙伴的地位,支持肿瘤学创新,并提供改善全球患者护理的诊断解决方案。

About Sysmex Inostics

关于Sysmex Inostics

Sysmex Inostics, Inc., a subsidiary of Japan's Sysmex Corporation, is a Baltimore-based biotechnology firm and CLIA-certified lab offering biomarker testing to accelerate the development of personalized medicine. Pioneering liquid biopsy technology with OncoBEAM in 2008, Sysmex Inostics now provides next generation sequencing Plasma-Safe-SeqS technology panels. The Plasma-Safe-SeqS panels empower more accurate detection of low-frequency biomarkers with ultra-sensitive 0.03% to 0.05% allele frequency from a simple blood draw to expedite studies and uncover deeper insights into therapy response. The company offers CLIA validated NGS testing services for HPV16/18 quantification, HNSCC, AML, breast cancer, and solid tumors impacted by RAS-RAF and PI3K signaling pathways.

Sysmex Inostics公司是日本Sysmex Corporation的子公司,总部位于巴尔的摩,是一家生物技术公司和CLIA认证实验室,提供生物标志物测试以加速个性化医疗的发展。该公司在2008年开创了液体活组织检查技术OncoBEAm,现提供下一代测序Plasma-Safe-SeqS技术面板。Plasma-Safe-SeqS面板能够通过简单的抽血实现更精确地检测低频生物标志物,具有超高灵敏度,等位基因频率为0.03%到0.05%,从而加快研究进程,深入了解治疗反应。该公司提供针对HPV16/18定量、头颈部鳞状细胞癌(HNSCC)、急性髓性白血病(AML)、乳腺癌和受RAS-RAF及PI0.3万信号通路影响的实体肿瘤的CLIA验证NGS测试服务。

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SOURCE Sysmex Inostics

来源:Sysmex Inostics

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