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. MolecularMD 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 MolecularMD’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. MolecularMD’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. MolecularMD 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 & Analysis Next Generation Sequencing Sanger Sequencing Allele-Specific PCR Digital PCR ABI 3730xl ABI 7500 Fast Dx* BioRad QX200 Illumina MiSeq Ion Torrent PGM Ion Torrent S5 Qiagen Rotor Gene Q MDx* QuantStudio Dx*
Gene Expression Analysis RT-qPCR Digital Color Barcodes (multiplex) ABI 7500 Fast Dx* Qiagen Rotor Gene Q MDx* QuantStudio Dx*
Protein Expression Analysis Immunohistochemistry (IHC) Digital Pathology Imaging & Quantitative Analysis Dako Omnis Indica Labs HALO® Leica Aperio* Leica Bond III* Tissue Phenomics Ventana Benchmark Ventana iScan Coreo
Structural Variation Detection & Analysis (CNV, Fusions & Translocations) Next Generation Sequencing CISH/SISH Abbott Vysis ABI 3500xL Dx* Archer AMP Chemistry Dako Omnis Illumina MiSeq Ion Torrent PGM Ion Torrent S5 Leica Bond III* Ventana Benchmark
Liquid Biopsy/ctDNA Next Generation Sequencing Droplet Digital PCR Bio-Rad QX200 Illumina MiSeq Ion Torrent PGM
DNA/RNA Extraction Manual & Automated PAXgene® Blood RNA System* Promega Maxwell CSC* Qiagen QIAcube

*FDA Cleared