HTG Molecular can help drug development teams build a deployable oncology biomarker strategy for their drug. The major elements are:
An Experienced Team of Diagnostic Experts
The leadership team at HTG has over 200 years of diagnostic experience and has successfully developed and commercialized companion diagnostics for HER2 and c-Kit.
Advantaged For FFPE
HTG's lysis only extraction free chemistry eliminates the need for extraction. This greatly reduces the risk that a biomarker hypothesis built off a cell based or fresh tissue assay will break down when the assay moves to formlin-fixed, paraffin embedded (FFPE). Eliminating extraction can also greatly improve workflow and ease of use.
HTG's assay is also robust and can be insensitive to sample prep variability such as fixation type, fixation conditions, cut slide stability and sample age.
Advantaged For Small Samples
HTG's assay requires a fraction of the sample input of other molecular techniques, typically just one 5 μm cut of FFPE. And when paired with a Next-generation Sequencing (NGS) detector, HTG can provide thousands of potentially clinically relevant data points from a single patient sample.
HTG's assay has the ability to run gene expression, gene fusions, DNA mutations and copy number variations – enabling significant platform consolidation and greatly increasing the amount of clinically actionable data from less patient sample.
HTG's Edge system provides easy walk away automation in less than 60 minutes of hands on time per assay and leverages the advantages of NGS detection to increase multiplex capability, dynamic range and sensitivity.
Right Assay - Right Time
|L1 (RUO)||L2 (RUOPlus)||L3 (IUO)|
|Biomarker Discovery||Biomarker Discovery||CMRD/FRD/Trace|
|Housekeeper Selection||Housekeeper Selection||Design/Development Plan|
|Custom Assay Development||Custom Assay Development||Design Verification|
|Instrument Integration||Instrument Integration||Process Design/Development|
|IVT Specificity Studies||Device Master Record|
|LLOD/LLOQ (dilution studies)||Software Validation|
|Reproducibility Studies||Design Validation|
|Prototype Verification/Validation||Process Validation|
|Analytical Validation||Design History File|
|Executed Clinical Plan|