4
Patient safety & Prevention of Malpractice Accurate Diagnostics QC at every step in the workflow CAP and NABL accredited NGS lab Rigorous validation of NGS protocols Internationally benchmarked tests CAP-validated bioinformatics and analytics protocols A Acc D ccu Dia ura iag rat gno te nos osti tics cs # 8750941 Certificate No. MC-2434 NABL Strand Center for Genomics and Personalized Medicine is CAP & NABL Accredited

Strand Center for Genomics and Personalized Medicine is ... · Strand Center for Genomics and Personalized Medicine (Strand Center) has received accreditation from the College of

  • Upload
    others

  • View
    6

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Strand Center for Genomics and Personalized Medicine is ... · Strand Center for Genomics and Personalized Medicine (Strand Center) has received accreditation from the College of

Patient safety & Prevention of Malpractice

Accurate Diagnostics

QC at every step

in the work�ow

CAP and NABL accredited

NGS lab

Rigorous validation

of NGS protocols

Internationally benchmarked

tests

CAP-validated bioinformatics and analytics

protocols

Accurate Accurate Diagnostics

Accurate Diagnostics

Accurate Diagnostics

Accurate Diagnostics

Accurate DiagnosticsDiagnosticsDiagnosticsDiagnostics

# 8750941

Certi�cate No. MC-2434

NABL

Strand Center for Genomics and Personalized Medicine is CAP & NABL Accredited

Page 2: Strand Center for Genomics and Personalized Medicine is ... · Strand Center for Genomics and Personalized Medicine (Strand Center) has received accreditation from the College of

# 8750941

CAP Accreditation- Ensuring High Quality Analyses

Strand Center for Genomics and Personalized Medicine (Strand Center) has received accreditation from the College of American Pathologists (CAP), an internationally recognized organization for quality assurance in diagnostics. 203 checkpoint criteria have been implemented across the entire process from acquisition of samples to delivery of results.

A process audit is conducted every 6 months to ensure consistent and accurate analyses.

Accuracy of our custom-built bioinformatics work�ow is ascertained vide 25 quality check parameters, applied at each step of the analysis for all patient samples. Variations across repeated runs in all laboratory and analytical processes at Strand Center have been minimized to less than 10%.

Strand tests have been benchmarked against global competitors and found to be at par by an independent agency2.

Research At Strand Center Is Independent Of Clinical Business

Patient samples are analyzed using exactly the same protocols and probe panels used for validation, and without any arbitrary, non-validated changes.

In particular, no mixing of research and clinical samples is performed in the same run. Internal controls and research samples for process validations are run separately from patient samples. Clinical samples are validated against positive and negative controls to ensure sensitivity as well as accuracy in every iteration of NGS analysis.

Extensive records of our validation procedures ensure that clinical results are accurate.

Consistency in usage of test probes is maintained diligently. Clinical samples are run in multiples and controls are included with each set of patient samples.

Pro�ciency testing (where CAP sends us test samples and checks if we call these correctly) and benchmarking of NGS analyses and bioinformatics work�ow are conducted to ensure parity with global standards, at regular intervals.

Implementation Of CAP Guidelines Results In Enhanced Performance

Implementation of CAP guidelines shows reduction of methodological errors by 35% in clinical research settings1.

Patient care protocols resulted in enhanced performance (10-55%) post implementation of CAP guidelines3.

References:1. Ibrahim, F. et al. Good clinical laboratory practices improved pro�ciency testing performance at clinical trials centers in Ghana and Burkina Faso. PLoS One 7, e39098 (2012).2. Mori, Y., Levenson, V. & Otto, J. Tumor Genomic Pro�ling Reports from Di�erent Vendors: A Comparison with Respect to Clinical Action Ability of the Provided Data. Adv Mol Diag 1, 110–121 (2016).3. Sartin, J. S. et al. Implementing CAP Guidelines: Impediments and Opportunities. Wis. Med. J. 106, (2007).

Page 3: Strand Center for Genomics and Personalized Medicine is ... · Strand Center for Genomics and Personalized Medicine (Strand Center) has received accreditation from the College of

NABLCerti�cate No.

MC-2434

NABL Accreditation of Strand Center for Genomics and Personalized Medicine

The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of the Department of Science and Technology (DST), India.

NABL provides a formal recognition of testing procedures and diagnostic protocols to medical laboratories in India.

Strand Center for Genomics and Personalized Medicine has achieved NABL accreditation for its Next Generation Sequencing-based diagnostic tests.

StrandAdvantage 48 Gene Test, Strand® Germline Cancer Test, and Strand Rare Disease Test have been accredited by NABL. Accreditation of other diagnostic o�erings is in progress.

Criteria Strand Center (SCGMP)

Non-CAPAccredited lab

Number of CAP Checklist Criteria- Common List - 41 Yes No

Number of CAP Checklist Criteria- Molecular Processes List - 76 Yes No

Number of CAP Checklist Criteria- General List - 86 Yes No

6-month internal audit process – Mandatory for CAP accreditation Yes No

Internal QC processes established and documented Yes No

Alignment of Lab processes to CAP activity Menu Yes No

inspectors Yes No

each stepYes (less than or equal to

5-10%)Not

determined

Validation parameters in bioinformatics and interpretation steps

Yes – 25 parameters No

Yes – 100% No

Number of CAP Checklist Criteria- Molecular Processes List - 76 YesYesY No

6-month internal audit process – Mandatory for for f CAP accreditation YesYesY No

Alignment of Lab processes to CAP activity Menu YesYesY No

each stepYes (less than or equal Yes (less than or equal Y to

5-10%)Not

determined

Yes – 100%Yes – 100%Y No

Page 4: Strand Center for Genomics and Personalized Medicine is ... · Strand Center for Genomics and Personalized Medicine (Strand Center) has received accreditation from the College of

#StayAheadOfCancer youtube.com/c/StayAheadofCancer

About Strand®

A History of Innovative Genomic Research

Strand Life Sciences is a global genomic profiling company aimed at empowering cancer care and genetic testing for inherited diseases. Strand works with oncologists, pathologists, and community hospitals to enable faster clinical decision support for accurate molecular diagnosis, prognosis, therapy recommendations, and clinical trials. Strand’s central reference laboratories are located in Bangalore.

www.strandls.com

A Trusted Partner to Companies Worldwide

For 17 years, our genomics products and solutions have facilitated the work of leading researchers and medical geneticists in over 2,000 laboratories and 100 hospitals around the world.

2018 © Strand Life Sciences

Strand Center for Genomics & Personalized Medicine (A unit of Strand Life Sciences Pvt. Ltd.) UAS Alumni Association Building, Veterinary College Campus, Bellary Road, Hebbal, Bangalore – 560 024Phone: 1800-1200-695, [email protected], www.strandls.com