Dutch scale-up SkylineDx secures respected CAP/CLIA certification for US laboratory


ROTTERDAM (the Netherlands) and SAN DIEGO (US), June 26th, 2019: the Rotterdam headquartered diagnostics company has been granted CAP (College of American Pathologists) accreditation, following its CLIA (Clinical Laboratory Improvement Amendments) certification in December 2018 and became the first Dutch scale-up with a CAP and CLIA certified clinical laboratory in San Diego, joining an elite group of globally recognized facilities that operate at the highest level of quality laboratory standards. This milestone further solidifies the ambition to become a global player in the biotech industry, developing diagnostic tests that allow a patient to consider a more individual treatment strategy, also known as personalized medicine.


The CLIA regulations establish quality standards for laboratory testing performed on human material that originates from the United States. The certification is legally mandated for all laboratories and diagnostic equipment used for clinical testing and is recognized by the international market. “We are holding ourselves responsible for meeting the highest standards of laboratory practice and receiving CLIA certification is the best confirmation of commitment to high-quality, accurate and reliable laboratory processes regarding our diagnostic cancer tests”, says Dharminder Chahal, CEO SkylineDx.


“During the CAP accreditation process, inspectors meticulously examined our lab in San Diego to ensure that we meet CAP’s diverse and stringent requirements”, continues Dharminder Chahal, “that is an extensive procedure but a very necessary external audit on the definitions and implementation of our lab records, quality control procedures, staff qualifications, equipment, facilities and safety programs”.


“The whole SkylineDx team is conscious that we work for patients that are faced with difficult decisions and that a fast and adequate diagnostic service is of utmost importance. That we are now meeting the highest standard of excellence in clinical laboratory practices, is a fantastic step in the further growth of our company”, concludes Dharminder Chahal.


About SkylineDx

SkylineDx is a high-tech commercial-stage biotech company headquartered in Rotterdam, The Netherlands and a commercial office and CAP/CLIA certified laboratory in San Diego, California, USA. The company uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility. With the focus on diagnostics, SkylineDx assists healthcare professionals in accurately determining the type or status of the disease or to predict a patient’s response to a specific treatment. Based on the test results, healthcare professionals can tailor the treatment to the individual patient. To learn more, please visit www.skylinedx.com.