Overview

Providing an Agile Approach to Diagnostic Platform and Method Selection

MolecularMD collaborates with the most prominent platform manufacturers, and has development agreements in place that enable a path to an in-vitro diagnostic designation for codeveloped diagnostic assays. MMD pursues Certified Service Provider designations from best in class platform companies which ensures laboratory proficiency and provides a higher level of technical support. It is MMD’s philosophy to collaborate and partner with a diverse range of diagnostic platform manufacturers in order to have access to the technologies that best fits its clients’ needs for clinical trial assays and in-vitro diagnostics. Limiting a drug program to a single diagnostic platform early in the development of a diagnostic assay can lead to higher costs and can introduce unnecessary risks. MMD’s solutions are designed to manage the risk and uncertainty associated with the oncology codevelopment process and are agile, capable of adapting to changes in strategy. Platform diversity combined with broad development and deployment capabilities are attributes that our clients value. MMD leverages technologies that address all major types of biomarkers and pair them with the most ideal diagnostic platforms and validated methods available.

Technologies and Platforms

Application Methods Platforms /Technologies
DNA Mutation Detection and Analysis Next Generation Sequencing
Sanger Sequencing
Allele Specific-PCR
Digital PCR
Ion Torrent PGM
Ion Torrent S5
Illumina MiSeq
ABI 3730xl
ABI 7500 Fast Dx*
QuantStudio Dx*
Qiagen Rotor Gene Q MDx*
BioRad QX200
Gene Expression Analysis RT-qPCR
Digital Color Barcodes (multiplex)
ABI 7500 Fast Dx*
QuantStudio Dx*
Qiagen Rotor Gene Q MDx*
Nanostring nCounter
Protein Expression Analysis Immunohistochemistry (IHC) Digital Pathology Imaging and Quantitative Ventana Benchmark
Leica Bond-III*
Leica Aperio*
Ventana iScan Coreo
Structural Variation Detection and Analysis (CNV, Fusions and Translocations) Next Generation Sequencing CISH/SISH Ion Torrent PGM
Ion Torrent S5
Illumina MiSeq
Archer AMP Chemistry
Abbott Vysis
Leica Bond III*
Ventana Benchmark
Liquid Biopsy/ctDNA Next Generation Sequencing Digital PCR Ion Torrent PGM
Illumina MiSeq
Bio-Rad QX200
DNA/RNA Extraction Manual and Automated Qiagen QIAcube Promega Maxwell CSC* PAXgene Blood RNA Blood*

*FDA Cleared