Biovica announces that it has received Laboratory Accreditation from the College of American Pathologists for its Clinical Laboratory Improvement Amendments -certified laboratory in San Diego, California.
UPPSALA, SWEDEN / ACCESSWIRE / October 16, 2023 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) Biovica today announces that it has received Laboratory Accreditation from the College of American Pathologists (CAP) for its Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory in San Diego, California. CAP accreditation is awarded to laboratories that meet stringent requirements and maintain the highest standards for laboratory operations of quality, accuracy, and consistency, as outlined by CAP.
CAP accreditation offers several commercial advantages. It facilitates the process of obtaining reimbursement from private insurance providers and enables DiviTum® TKa expansion into New York, Maryland, and Washington D.C. Post license application and approval, Biovica will be able to offer DiviTum also in these locations and thereby be able to cover the entire US. In addition, CAP accreditation is a highly coveted credential, particularly among pharmaceutical and biotechnology companies. They seek it out when they require a more rigorous regulatory framework for their projects, especially when the data generated is intended for submission to the U.S. Food and Drug Administration (FDA).
“I take great pride in the efforts put forth by our team to reach this significant milestone. Attaining CAP accreditation underscores our unwavering commitment to quality.”, says Warren Cresswell, President of the Americas at Biovica.
About CAP
The College of American Pathology (CAP) was founded in 1961 in the United States for laboratory quality control and is one of the world’s most prestigious accreditation bodies. Through an application process, CAP reviews and accredits laboratories across the United States to ensure these laboratories meet certain safety and patient care criteria, helping laboratories maintain the accuracy of test results, ensuring accurate patient diagnosis, and meeting required standards from CLIA, FDA, and OSHA. CAP accreditation is known as the gold standard for laboratory quality control worldwide and ensures that quality control standards strict enough to conduct testing for clinical diagnostic purposes.
Contact
Anders Rylander, CEO
Phone: +46 76 666 16 47
E-mail: anders.rylander@biovica.com
Anders Morén, CFO
Phone: +46 73 125 92 46
E-mail: anders.moren@biovica.com
Biovica - Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica’s assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica’s vision is: “Improved care for cancer patients.” Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica’s shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company’s Certified Adviser. For more information, please visit: www.biovica.com
Attachments
Biovica receives CAP Accreditation for its CLIA Laboratory
SOURCE: Biovica International
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