Lab-Developed Tests Compared with Approved Diagnostics
By LabMedica International staff writers Posted on 30 Jan 2018 |
Image: The FDA-approved BRACAnalysis CDx test as a companion diagnostic (Photo courtesy of Myriad Genetics).
The debate about the role of the government-approved diagnostics in the regulation of laboratory-developed tests (LDTs) has focused attention on the analytical performance of all clinical laboratory testing.
This is particularly important when it comes to detecting common types of cancer mutations such as the B-Raf proto-oncogene, serine/threonine kinase (BRAF), the epidermal growth factor receptor (EGFR), and Kirsten rat sarcoma virus (KRAS) oncology analytes.
A team of scientists from different institutions and led by those at (Brigham and Women's Hospital, Boston, MA, USA) compared the performance of LDTs and US Food and Drug Administration (FDA, Silver Springs, MD, USA) approved companion diagnostics (FDA-CDs), in proficiency testing (PT) provided by the College of American Pathologists Molecular Oncology Committee (CAP, Northfield, IL, USA). The team analyzed the performance of 6,897 tests from laboratories participating in the CAP Proficiency Testing (PT) for BRAF, EGFR, and KRAS, oncology analytes used often by both LDTs and FDA-CDxs. A total of 6,897 PT responses were included: BRAF (n = 2,524; 14 PT samples), EGFR (n = 2,216; 11 PT samples), and KRAS (n = 2,157, 10 PT samples). FDA ompanion diagnostics and LDTs are compared for both accuracy and preanalytic practices of the laboratories.
Using CAP standards, they compared accuracy and preanalytic practices of the laboratories and found that both types of tests exceeded 97% accuracy across the three cancer genes. In another important finding, the scientists discovered that at least 60% of the participating laboratories had adapted an FDA-CDx test to the point that it changed the classification to an LDT. According to the specialists, laboratories did this to “allow for a greater breadth of sample types, minimum tumor content, and instrumentation.” From a regulatory perspective, the data suggest that there’s not as much of a difference between FDA-CDxs and LDTs as previously thought. The high marks on LDT proficiency are significant, given the scrutiny these tests have experienced over their reliability. FDA for some time has advocated for increased oversight of LDTs, claiming that they should be regulated as medical devices.
Annette S. Kim, MD, PhD, an associate pathologist and first author of the study, said, “These modifications appear to be driven by the exigencies of real day-to-day clinical practice that requires altering the assays to meet the needs of a variety of clinical situations that may not be accommodated by the FDA-approved protocol.” The study was published originally published online on December 14, 2017, in the journal JAMA Oncology.
Related Links:
Brigham and Women's Hospital
US Food and Drug Administration
College of American Pathologists
This is particularly important when it comes to detecting common types of cancer mutations such as the B-Raf proto-oncogene, serine/threonine kinase (BRAF), the epidermal growth factor receptor (EGFR), and Kirsten rat sarcoma virus (KRAS) oncology analytes.
A team of scientists from different institutions and led by those at (Brigham and Women's Hospital, Boston, MA, USA) compared the performance of LDTs and US Food and Drug Administration (FDA, Silver Springs, MD, USA) approved companion diagnostics (FDA-CDs), in proficiency testing (PT) provided by the College of American Pathologists Molecular Oncology Committee (CAP, Northfield, IL, USA). The team analyzed the performance of 6,897 tests from laboratories participating in the CAP Proficiency Testing (PT) for BRAF, EGFR, and KRAS, oncology analytes used often by both LDTs and FDA-CDxs. A total of 6,897 PT responses were included: BRAF (n = 2,524; 14 PT samples), EGFR (n = 2,216; 11 PT samples), and KRAS (n = 2,157, 10 PT samples). FDA ompanion diagnostics and LDTs are compared for both accuracy and preanalytic practices of the laboratories.
Using CAP standards, they compared accuracy and preanalytic practices of the laboratories and found that both types of tests exceeded 97% accuracy across the three cancer genes. In another important finding, the scientists discovered that at least 60% of the participating laboratories had adapted an FDA-CDx test to the point that it changed the classification to an LDT. According to the specialists, laboratories did this to “allow for a greater breadth of sample types, minimum tumor content, and instrumentation.” From a regulatory perspective, the data suggest that there’s not as much of a difference between FDA-CDxs and LDTs as previously thought. The high marks on LDT proficiency are significant, given the scrutiny these tests have experienced over their reliability. FDA for some time has advocated for increased oversight of LDTs, claiming that they should be regulated as medical devices.
Annette S. Kim, MD, PhD, an associate pathologist and first author of the study, said, “These modifications appear to be driven by the exigencies of real day-to-day clinical practice that requires altering the assays to meet the needs of a variety of clinical situations that may not be accommodated by the FDA-approved protocol.” The study was published originally published online on December 14, 2017, in the journal JAMA Oncology.
Related Links:
Brigham and Women's Hospital
US Food and Drug Administration
College of American Pathologists
Latest Pathology News
- Robotic Blood Drawing Device to Revolutionize Sample Collection for Diagnostic Testing
- Use of DICOM Images for Pathology Diagnostics Marks Significant Step towards Standardization
- First of Its Kind Universal Tool to Revolutionize Sample Collection for Diagnostic Tests
- AI-Powered Digital Imaging System to Revolutionize Cancer Diagnosis
- New Mycobacterium Tuberculosis Panel to Support Real-Time Surveillance and Combat Antimicrobial Resistance
- New Method Offers Sustainable Approach to Universal Metabolic Cancer Diagnosis
- Spatial Tissue Analysis Identifies Patterns Associated With Ovarian Cancer Relapse
- Unique Hand-Warming Technology Supports High-Quality Fingertip Blood Sample Collection
- Image-Based AI Shows Promise for Parasite Detection in Digitized Stool Samples
- Deep Learning Powered AI Algorithms Improve Skin Cancer Diagnostic Accuracy
- Microfluidic Device for Cancer Detection Precisely Separates Tumor Entities
- Virtual Skin Biopsy Determines Presence of Cancerous Cells
- AI Detects Viable Tumor Cells for Accurate Bone Cancer Prognoses Post Chemotherapy
- First Ever Technique Identifies Single Cancer Cells in Blood for Targeted Treatments
- Innovative Blood Collection Device Overcomes Common Obstacles Related to Phlebotomy
- Intra-Operative POC Device Distinguishes Between Benign and Malignant Ovarian Cysts within 15 Minutes