Single source internal standard manufacture
- Routine development of MDx kits for any qPCR platform
- FDA Approval on market accepted and validated platform
- microplate based methods are preferred
Quantification by nucleic acid platforms capable of measuring molar ratios
- Robust measurements not possible with the current real-time and microarray based platforms
- attract companion diagnostic partnerships with pharmaceutical companies
- Improves adoption by translational research & MDx partners
Tens to hundreds of robust qPCR measurements from limited degraded patient sample
- SNAQ uses competitive PCR and melting curve analysis to measure ratio between a target and a known quantity of competitive template.
- mixtures of internal Standards to control for variation between instruments, users, samples and laboratories.
- Two-step SNAQ enables tens to hundreds of qPCR measurements from limited sample while maintaining analytic accuracy and sensitivity.
- SNAQ is compatible with existing real-time instrument, “off-line” amplification in any block thermocycler
AccuGenomics will utilize their proprietary standards in the development of their own proprietary molecular diagnostic tests as well as new and existing relevant molecular diagnostic tests on Multiple Platforms enabling the transition from a research biomarker to a commercial diagnostic test.
Proprietary Standards Provide Quantitative, Standardized, Numerical Measurements that provide gene expression based molecular diagnostics tests to be standardized and used for therapeutic intervention, monitoring and diagnosis of disease.
AccuGenomics Patented Standards Provides inter and intra test comparability (across samples, time and users) and absolute quantification of transcript abundance results.
- Analytical Sensitivity and Assay Limits (lower detection threshold, linear dynamic range, signal-to-analyte response)
- Precision (within assay variability, repeatability-within-day variability, reproducibility-day-to-day variability)
- Analytical Specificity (ability to differentiate similar analyte(s) or interference from sample(s)
- Interference (cross-contamination, interfering substances such as inhibitor reverse transcription and/or PCR amplification)
- Intrinsic Quality Control (control for analytical false negatives and false positives)
Standardized Data To Meet the performance characteristics for pharmacogenomic data which the FDA has identified as being necessary for the FDA’s consideration of such data as part of its regulatory approval process.