Custom Assays2019-08-07T07:03:40+00:00
CLINICAL LAB SERVICES

Custom Assays

CLINICAL LAB SERVICES

Custom Assays

Invivoscribe is partnering with laboratories worldwide to help facilitate the conversion of LDTs into FDA-cleared assays.

In response to the FDA announcing its intention to dramatically expand its regulatory oversight of laboratory developed tests (LDTs), Invivoscribe is partnering with laboratories worldwide to help facilitate the conversion of LDTs into FDA-cleared assays, as we know the barriers to bringing new assays online are often the availability of resources and the cost of validation.

Several patient-specific PCR-based (e.g. ASO-PCR) and flow cytometric technologies have been developed by regional test centers in order to routinely assess MRD levels during the course of therapy. However, ASO-PCR requires patient- and tumor-specific primer and probe sets, making it cost prohibitive and impossible to offer as a standardized method. Flow cytometry – even more sensitive multiparameter flow cytometry protocols – are difficult to standardize between testing centers. Both of these methods do not generate results that meet the internationally recognized criteria for harmonization for a quantitative measure of residual disease, and neither meet the regulatory standards required to take them through the regulatory agencies.

Next-Generation Sequencing (NGS) methods have recently been developed for the detection and monitoring of MRD. These forefront technologies use regulatory compliant chemistries, run on regulatory compliant instruments, and can be interpreted using regulatory compliant, and design-controlled bioinformatics software. Due to the read depth of this non-biased patient agnostic testing approach, ultra deep sequencing overcomes virtually all of the shortcomings of other MRD technologies, providing internationally harmonized MRD testing for virtually any targeted biomarker.

LabPMM’s MRD tests are NGS-based assays that can be used to detect clonal gene rearrangements identified at diagnosis within virtually all of the antigen receptor loci (B- and T-cells). Once a specific rearrangement sequence (the clonotype) has been identified in a primary sample, bioinformatics tools allow for easy tracking of clonal populations at greater sensitivity, provided sufficient DNA is tested. Sensitivity (limit of detection) is determined by the number of cell equivalents of DNA that are interrogated and the number of sequencing reads generated per sample.

LabPMM also offers FLT3 ITD and NPM1 MRD assays, which are used for the detection of targeted mutations at a sensitivity up to 10-5.

Invivoscribe is partnering with laboratories worldwide to help facilitate the conversion of LDTs into FDA-cleared assays.

In response to the FDA announcing its intention to dramatically expand its regulatory oversight of laboratory developed tests (LDTs), Invivoscribe is partnering with laboratories worldwide to help facilitate the conversion of LDTs into FDA-cleared assays, as we know the barriers to bringing new assays online are often the availability of resources and the cost of validation.

Several patient-specific PCR-based (e.g. ASO-PCR) and flow cytometric technologies have been developed by regional test centers in order to routinely assess MRD levels during the course of therapy. However, ASO-PCR requires patient- and tumor-specific primer and probe sets, making it cost prohibitive and impossible to offer as a standardized method. Flow cytometry – even more sensitive multiparameter flow cytometry protocols – are difficult to standardize between testing centers. Both of these methods do not generate results that meet the internationally recognized criteria for harmonization for a quantitative measure of residual disease, and neither meet the regulatory standards required to take them through the regulatory agencies.

Next-Generation Sequencing (NGS) methods have recently been developed for the detection and monitoring of MRD. These forefront technologies use regulatory compliant chemistries, run on regulatory compliant instruments, and can be interpreted using regulatory compliant, and design-controlled bioinformatics software. Due to the read depth of this non-biased patient agnostic testing approach, ultra deep sequencing overcomes virtually all of the shortcomings of other MRD technologies, providing internationally harmonized MRD testing for virtually any targeted biomarker.

LabPMM’s MRD tests are NGS-based assays that can be used to detect clonal gene rearrangements identified at diagnosis within virtually all of the antigen receptor loci (B- and T-cells). Once a specific rearrangement sequence (the clonotype) has been identified in a primary sample, bioinformatics tools allow for easy tracking of clonal populations at greater sensitivity, provided sufficient DNA is tested. Sensitivity (limit of detection) is determined by the number of cell equivalents of DNA that are interrogated and the number of sequencing reads generated per sample.

LabPMM also offers FLT3 ITD and NPM1 MRD assays, which are used for the detection of targeted mutations at a sensitivity up to 10-5.