press release- cap-iso accreditation

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4/14/2016 BioSpace - Print News Article http://www.biospace.com/news_print.aspx?NewsEntityId=410090 1/2 Life Sciences Jobs • Newest Jobs Last 24 Hours • California Jobs • Massachusetts Jobs • New Jersey Jobs • Maryland Jobs • Washington Jobs View More Jobs Print Strand Life Sciences ’ NGS Laboratory First In India To Receive Both CAP And NABL Accreditations 2/25/2016 10:59:00 AM BANGALORE, India & DENVER(BUSINESS WIRE )Strand Life Sciences, a global genomic profiling company aimed at empowering personalized cancer care and genetic testing for inherited diseases, announced that its NextGeneration 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 & 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. “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 multigene testing in genomic medicine, it is important for us to set the highest laboratory standards.” The CAP laboratory accreditation program is recognized by the U.S. federal government as equalto or more stringentthan the government’s own laboratory inspection programs. Similarly, the accreditation by NABL, the sole governmentauthorized 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 48gene 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 86gene hereditary cancer test to estimate inherited cancer risk, enabling early detection & 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 genomicsbased 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 multigene 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.

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Page 1: Press release- CAP-ISO accreditation

4/14/2016 BioSpace - Print News Article

http://www.biospace.com/news_print.aspx?NewsEntityId=410090 1/2

Life Sciences Jobs

• Newest Jobs Last 24 Hours

• California Jobs

• Massachusetts Jobs

• New Jersey Jobs

• Maryland Jobs

• Washington Jobs

View More Jobs

Print

Strand Life Sciences’ NGS Laboratory First In India To Receive Both CAP And NABL Accreditations 2/25/2016 10:59:00 AM

BANGALORE, India & DENVER(BUSINESS WIRE)Strand LifeSciences, a global genomic profiling company aimed at empoweringpersonalized cancer care and genetic testing for inherited diseases,announced that its NextGeneration Sequencing (NGS) laboratory, theStrand Center for Genomics & Personalized Medicine, located atBangalore, has recently received certificates of accreditation from theCollege of American Pathologists (CAP), and the NationalAccreditation Board for Testing & Calibration Laboratories (NABL),respectively. With these accreditations, Strand’s pioneering NGSlaboratory is the first and only facility in India to receive bothprestigious recognitions, signifying NGS testing at the highest qualitystandards in the country and neighboring geographical regions.

“We believe Strand’s NGS laboratory is the first and only CAPand NABL accredited laboratory in India. As the regional leaderin this advanced field of multigene testing in genomic medicine,it is important for us to set the highest laboratory standards.”

The CAP laboratory accreditation program is recognized by the U.S. federal government as equalto or morestringentthan the government’s own laboratory inspection programs. Similarly, the accreditation by NABL, the solegovernmentauthorized laboratory accreditation body in India, is in accordance with ISO 15189:2012 standards. Theaccrediting processes by both organizations are designed to ensure that laboratories comply with the higheststandards, and adhere to rigorous criteria for quality assurance. During the CAP accreditation process, inspectorsexamine the laboratory's quality system, quality control protocols and records for the preceding two years. Bothprograms pay very close attention to staff qualification, equipment, safety programs, and overall management ofclinical laboratories.

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

Dr. Vijay Chandru, PhD, Executive Chairman, Strand Life Sciences, stated, “We are extremely proud to receiveCAP and NABL accreditations. Receiving these accreditations is a major accomplishment, because it reaffirms ourcommitment to providing the highest quality of diagnostic testing and services to hospitals, physicians, and mostimportantly patients across the country. It is Strand’s goal to bring genomicsbased precision medicine to routineclinical practice; hence the accreditations serve as an important milestone in that direction”. Dr. Chandru added, “Webelieve Strand’s NGS laboratory is the first and only CAP and NABL accredited laboratory in India. As the regionalleader in this advanced field of multigene testing in genomic medicine, it is important for us to set the highestlaboratory standards."

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

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

Page 2: Press release- CAP-ISO accreditation

4/14/2016 BioSpace - Print News Article

http://www.biospace.com/news_print.aspx?NewsEntityId=410090 2/2

About Strand Life Sciences

A History of Innovative Genomic Research

Strand Life Sciences is a global genomic profiling company aimed at empowering cancer care and genetic testing forinherited diseases. Strand works with oncologists, pathologists, and hospitals to enable faster clinical decision supportfor accurate molecular diagnosis, prognosis, therapy recommendations, and clinical trials. Strand’s central referencelaboratories are located in Bangalore, India and Colorado, USA. For more information, visit www.strandls.com.

About the College of American Pathologists

As the leading pathology organization with more than 18,000 boardcertified pathologist members, the College ofAmerican Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence inthe practice of pathology and laboratory medicine. The CAP's Laboratory Improvement Programs, initiated 65 yearsago, currently has customers in more than 100 countries, accrediting 7,700 laboratories and providing proficiencytesting to 20,000 laboratories worldwide. For more information, visit www.cap.org.

About National Accreditation Board for Testing and Calibration Laboratories

NABL is an autonomous body under the aegis of Department of Science & Technology, Government of India, and isregistered under the Societies Act 1860. NABL has been established with the objective to provide Government,Industry Associations and Industry in general with a scheme for thirdparty assessment of the quality and technicalcompetence of testing and calibration laboratories. Government of India has authorized NABL as the accreditationbody for Testing and Calibration Laboratories. NABL provides laboratory accreditation services to laboratories that areperforming tests / calibrations in accordance with ISO/IEC 17025 and ISO 15189 for medical laboratories. NABLaccreditation system complies with with Asia Pacific Laboratory Accreditation Cooperation (APLAC) and theInternational Laboratory Accreditation Cooperation (ILAC). For more information, visit www.nablindia.org.

ContactsOgilvy PR, BangaloreSoumita Majumdar, +91 [email protected]/orAkriti Agrawal, +91 [email protected]

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