MASH / MAFLD Clinical Trial Assays
MASH / MAFLD Clinical Trial Assays
Almac has developed and analytically validated qPCR genotyping CTAs from blood and buccal specimen types for both PNPLA3 and HSD17B13 genes to determine molecular eligibility for MASH /MAFLD Trials.
The assays are designed to process up to 22 specimens per run with a turnaround time of 5-7 days from specimen receipt at Almac Diagnostic Services.
PNPLA3 Assay Intended Use
The PNPLA3 Genotyping Clinical Trial Assay (CTA) is a qualitative polymerase chain reaction (PCR) in vitro diagnostic (IVD) assay that allows identification of the I148M (rs738409) genotype within the PNPLA3 gene from DNA isolated from whole blood or buccal swabs and using the QuantStudio5™ Dx instrument.
The Assay will be used to determine the PNPLA3 genotype of subjects that are candidates for clinical trials, evaluating the clinical safety and effectiveness of investigational medicinal products for the treatment of MASH/MAFLD.
The PNPLA3 Genotyping CTA is intended for investigational use only, with testing to be performed at Almac Diagnostic Services’ Clinical Laboratory Improvement Amendments (CLIA) / College of American Pathologists (CAP) accredited laboratories located at 19 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK and 4238 Technology Drive, Durham, NC, USA.
HSD17B13 Assay Intended Use
The HSD17B13 Genotyping Clinical Trial Assay (CTA) is a qualitative polymerase chain reaction (PCR) in vitro diagnostic (IVD) assay that allows allelic discrimination of rs72613567 (Adenine insertion) within the HSD17B13 gene from DNA derived from whole blood or buccal swabs using the QuantStudio5™ Dx instrument.
The Assay will be used to determine the HSD17B13 genotype of subjects that are candidates for clinical trials, evaluating the clinical safety and effectiveness of investigational medicinal products for the treatment of MASH/MAFLD.
The HSD17B13 Genotyping CTA is intended for investigational use only, with testing to be performed at Almac Diagnostic Services’ Clinical Laboratory Improvement Amendments (CLIA) / College of American Pathologists (CAP) accredited laboratories located at 19 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK and 4238 Technology Drive, Durham, NC, US.
Level of Analytical Validation & Compliance
Key Benefits
- High Accuracy, Sensitivity, Specificity & Reproducibility (100%)
- EU & US Regulation Compliant for Clinical Trial Use
- Delivered from Almac Global Accredited Labs (CLIA / CAP / ISO15189)
DOWNLOAD ALMAC ASSAY FACT SHEETS
