CAP and NABL Accreditations for Strand Life Sciences’ NGS Laboratory

Strand Life Sciences, a global genomic profiling company aimed at empowering personalized cancer care and genetic testing for inherited diseases, announced that its Next-Generation Sequencing (NGS) laboratory, the Strand Center for Genomics & Personalized Medicine, located at Bangalore, has recently received certificates of accreditation from the College of American Pathologists (CAP), and the National Accreditation Board for Testing and Calibration Laboratories (NABL), respectively. With these accreditations, Strand’s pioneering NGS laboratory is the first and only facility in India to receive both prestigious recognitions, signifying NGS testing at the highest quality standards in the country and neighboring geographical regions.

The CAP laboratory accreditation program is recognized by the U.S. federal government as equal-to or more-stringent-than the government’s own laboratory inspection programs. Similarly, the accreditation by NABL, the sole government-authorized laboratory accreditation body in India, is in accordance with ISO 15189:2012 standards. The accrediting processes by both organizations are designed to ensure that laboratories comply with the highest standards, and adhere to rigorous criteria for quality assurance. During the CAP accreditation process, inspectors examine the laboratory's quality system, quality control protocols and records for the preceding two years. Both programs pay very close attention to staff qualification, equipment, safety programs, and overall management of clinical laboratories.

This recognition by CAP and NABL accredits three of the most popular tests offered by the Strand Center laboratory. First, the StrandAdvantage 48-gene Test, used by medical oncologists to profile cancer patients for somatic mutations and personalize treatment by selecting targeted therapies. Second, the Strand Germline Cancer Test, an 86-gene hereditary cancer test to estimate inherited cancer risk, enabling early detection and prevention. Third, the Strand Rare Diseases Test, covering more than 500 genes and 400 rare inherited diseases, used for confirmation of diagnosis and carrier testing in couples.

Dr. Vijay Chandru, PhD, Executive Chairman, Strand Life Sciences, stated, “We are extremely proud to receive CAP and NABL accreditations. Receiving these accreditations is a major accomplishment, because it reaffirms our commitment to providing the highest quality of diagnostic testing and services to hospitals, physicians, and most importantly patients across the country. It is Strand’s goal to bring genomics-based precision medicine to routine clinical practice; hence the accreditations serve as an important milestone in that direction”. Dr. Chandru added, “We believe Strand’s NGS laboratory is the first and only CAP and NABL accredited laboratory in India. As the regional leader in this advanced field of multi-gene testing in genomic medicine, it is important for us to set the highest laboratory standards."

“It is imperative that physicians feel confident while sending patient samples for specialized and esoteric testing, such as NGS for cancer and rare inherited disorders. These diagnostic tests require advanced laboratories and expert personnel to analyze and interpret complex genetic information. Laboratories whose quality systems have been accredited by organizations such as CAP and NABL will give physicians much needed confidence to refer precious patient samples” said Dr. Nanda Rajaneesh, MBBS, MS, MRCS, FAMS, Consultant Surgical Oncologist, Apollo Spectra Hospitals, Bangalore.

Dr. Preveen Ramamoorthy, PhD, Global Head of Diagnostics, Strand Life Sciences, said, “Our NGS facility in Aurora, Colorado, is a Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory. Now, the accreditation of our India facility by CAP and NABL (ISO 15189) validates our ability to perform high quality clinical NGS testing and perform bioinformatics and clinical interpretation to international quality standards in every facility that we operate.