#USA #Baltimore #Liquid Biopsy #CAP Accreditation #Sysmex Inostics

Sysmex Inostics Achieves CAP Accreditation and ISO 15189 Certification

In a significant development for clinical diagnostics, Sysmex Inostics, a pivotal player in the liquid biopsy arena, has obtained both CAP accreditation and ISO 15189 certification. Based in Baltimore, this biotechnology firm specializes in providing innovative solutions aimed at improving patient care through advanced diagnostic methodologies.

Commitment to Quality and Reliability

The College of American Pathologists (CAP) accreditation is widely regarded as the benchmark in laboratory quality assurance. This recognition signifies that Sysmex Inostics has not only met but has surpassed stringent industry standards relating to accuracy, precision, and patient safety. Alongside this, the ISO 15189 certification emphasizes the company's dedication to quality management practices and technical competency, reinforcing the reliability of the test results that guide critical healthcare decisions.

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

Continuing Commitment to Improvement

The integration of CAP and ISO 15189 into Sysmex Inostics' quality system signifies a robust framework for ongoing improvement, propelling the company toward meeting international standards while bolstering confidence among clinicians, researchers, and partners in the accuracy and reproducibility of its results across diverse diagnostic applications.

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

Advancing Precision Medicine

With these new accreditations solidifying its reputation, Sysmex Inostics is poised to continue contributing significantly to the progression of precision medicine, particularly within the oncology sector. The firm’s commitment to providing innovative diagnostic solutions is critical in enhancing patient care on a global scale.

As a subsidiary of Japan's Sysmex Corporation, Sysmex Inostics has been at the forefront of liquid biopsy technology since the launch of its OncoBEAM™ platform in 2008. They have since expanded their offerings to include next-generation sequencing technology, enhancing the ability to detect low-frequency biomarkers from a simple blood draw.

Their Plasma-Safe-SeqS technology has made strides in research and clinical applications, leading to more accurate results that aid in therapy response analyses. Certified under CLIA, the laboratory offers a variety of services, including those for HPV16/18 quantification, head and neck squamous cell carcinoma, acute myeloid leukemia, breast cancer, and more. This comprehensive range is supported by a deep commitment to research and innovation, fostering improvements in the landscape of personalized medicine.

Conclusion

The recognition of Sysmex Inostics through CAP accreditation and ISO 15189 certification showcases a formidable commitment to quality standards that ultimately benefits healthcare professionals and patients alike. With a focus on reliability and precision, Sysmex Inostics is strategically positioned to continue leading advancements in diagnostic solutions, ensuring that healthcare decisions are informed by the most precise data available, thereby making significant contributions to patient outcomes globally.