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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 獲得 CAP 認證和 ISO 15189 認證,提升了診斷卓越的質量標準。
PR Newswire ·  12/11 03:15

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.

巴爾的摩,2024年12月10日 /PRNewswire/ -- Sysmex Inostics,全球領先的創新液體活檢解決方案提供商,自豪地宣佈其最近獲得了美國病理學家協會(CAP)的認證以及ISO 15189標準下的認證。這些有聲望的認可重申了Sysmex Inostics致力於在其臨床診斷和實驗室服務中提供最高水平的質量和可靠性。

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認證被視爲實驗室質量保證的金標準,意味着Sysmex Inostics已經滿足或超過了嚴格的行業標準,確保精確性、準確性和患者安全。ISO 15189認證進一步強調了實驗室對質量管理和技術能力的承諾,確保了支持重要醫療決策的測試結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."

"獲得CAP認證和ISO 15189認證是我們致力於提供診斷卓越的重大里程碑," Sysmex Inostics商業運營副總裁Aaron J. Lizee表示。"這些成就反映了我們團隊的辛勤工作和奉獻精神,展示了我們對質量和患者結果的堅定關注。"

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的加入增強了Sysmex Inostics質量體系,使實驗室能夠滿足國際標準,並確保一個持續改進的堅實框架。這些認證爲臨床醫生、研究人員和合作夥伴提供信心,通過強化各種診斷應用中結果的準確性和可重複性。

"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."

"我們增強的質量體系使我們能夠達到最高的監管和操作標準," 監管事務與質量保證高級董事Takeisha Wright補充道。"這一成就不僅僅是關於合規;它是關於爲診斷卓越設立標準,確保我們的客戶和患者獲得最可靠的數據,以指導救生決策。"

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.

通過將這些認證整合到其質量體系中,Sysmex Inostics鞏固了其作爲推進精準醫療的可信賴夥伴的地位,支持腫瘤學創新,並提供改善全球患者護理的診斷解決方案。

About Sysmex Inostics

關於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,總部位於巴爾的摩,是一家生物技術公司和CLIA認證實驗室,提供生物標誌物測試以加速個性化醫療的發展。該公司在2008年開創了液體活組織檢查技術OncoBEAm,現提供下一代測序Plasma-Safe-SeqS技術面板。Plasma-Safe-SeqS面板能夠通過簡單的抽血實現更精確地檢測低頻生物標誌物,具有超高靈敏度,等位基因頻率爲0.03%到0.05%,從而加快研究進程,深入了解治療反應。該公司提供針對HPV16/18定量、頭頸部鱗狀細胞癌(HNSCC)、急性髓性白血病(AML)、乳腺癌和受RAS-RAF及PI0.3萬信號通路影響的實體腫瘤的CLIA驗證NGS測試服務。

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SOURCE Sysmex Inostics

來源:Sysmex Inostics

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