The following complimentary webcasts are scheduled. Please register to participate.
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Register for upcoming webinars here:
Date: February 4th, 2015
Time: 16:00-16:40 BST (London time)
Can you prove the accuracy of your assay?
‘Data accuracy’ has been ranked as the most important attribute by the sequencing community (Frost and Sullivan). However, the challenges facing laboratories in achieving this goal are highlighted in a recent worldwide EGFR Proficiency Testing Scheme: the External Quality Assessment 20141. Only 70% of the laboratories passed the EQA in line with the findings of other previous EQA schemes (KRAS & BRAF)2.
Perhaps reference materials provide the answer and there are many different available: Synthetic reference standards for example provide a renewable source (such as oligonucleotides/plasmids), however they tend to amplify more easily than equivalent template from cellular sources creating false-confidence in molecular assay workflows. Alternatively, patient-derived materials provide the ‘Gold Standard’ but come with a high degree of variability and are limited in supply which prohibits their daily use.
Therefore, laboratories face the challenge of sourcing reference materials that truly reflect patient samples with a defined copy number, precise allele burden and mimics genome complexity and tumour cell genetics, but are also renewable, consistent and reproducible.
Laboratory Developed Tests (LDTs) – What is their importance?
The vital information gained from clinical laboratory tests is now influencing approximately 70% of health care decisions with 6.8 billion clinical laboratory tests being performed in the United States annually alone3.
Due to the large influencing power on the ‘health care decision making’, the FDA on October 3, 2014, formally issued guidance: the “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” presents the details of a risk-based framework for regulating LDTs in three distinct categories due to four key reasons.
In the webinar we will discuss the latest developments surrounding the FDA and LDTs and will present examples of how reference materials could help your laboratory improve the accuracy of your assay.
Overview of current general validation requirements
The potential impact from FDA oversight on LDTs
Using genomic DNA as an external control to highlight and control variability in your assay
Hannah is a medical biochemist turned quality professional with a strong interest in the future of quality and regulatory management with focus on advances in medical technology. Hannah is involved with the Chartered Quality Institute predominantly as Vice Chair of the Next Generation Network and first appointed young representative to the Advisory Council, through which she advocates the role quality management in business.
Samantha is a Biochemistry major who studied in a Cancer Biology and High Content Screening Laboratory. She is passionate about accelerating science forward and working with accounts to improve their confidence that they are performing the right test, for the right patient and getting the right results to improve patient care.
The latest developments for molecular testing in LDTs, Sanger & qPCR sequencing will be presented as well as the regulatory changes.
Horizon Diagnostics is proud to support clinical laboratories with the provision of sustainable reference materials for research use; applications include the validation of equipment, consumables and laboratory developed tests (LDTs). This webinar will discuss a specific application of Horizon Diagnostic reference materials alongside the current (CLIA) and potential (FDA) expectation for verification and validation activities within the clinical laboratory. What do you believe to be the greatest impact of the potential FDA oversight of LDTs?
1.UnitedHealth Center for Health Reform and Modernization, “Personalized Medicine: Trends and prospects for the new science of genetic testing and molecular diagnostics,” Working Paper 7, March 2012,
2. Patton, S; Normanno, N; Blackhall, F; Murray, S; Kerr, K’ Dietel, M; Filipits, M; Benlloch, S; Popat, S; Stahel, R and Thunnissen, E. Assessing standardization of molecular testing for non-small-cell lung cancer: results of a worldwide external quality assessment (EQA) scheme for EGFR mutation testing. British Journal of Cancer (2014) 111, 413–420 | doi: 10.1038/bjc.2014.353
3. Deans ZC, Bilbe N, O’Sullivan B, Lazarou LP, de Castro DG, Parry S, Dodson A, Taniere P, Clark C, Butler R (2013) Improvement in the quality of molecular analysis of EGFR in non-small-cell lung cancer detected by three rounds of external quality assessment. J Clin Pathol 66: 319–325.
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