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

Sysmex Inostics (PRNewsfoto/Sysmex Inostics)

News provided by

Sysmex Inostics

Dec 10, 2024, 14:15 ET

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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.

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.

"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."

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.

"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."

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.

About 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.

For more information, refer to www.sysmex-inostics.com.

SOURCE Sysmex Inostics

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