The FDA’s National Center for Toxicological Research (NCTR) is conducting a market survey for immunoassay systems to detect cardiac toxicity biomarkers.
Drug-induced cardiac toxicity is one of the common adverse effects which cause the FDA concern. The level of cardiac troponin I, one of the most commonly used cardiac injury biomarkers, needs to be measured to help access the severity of drug-induced cardiac injury.
One of the challenges NCTR is facing is the low level of troponin I in mouse plasma compared to human plasma. NCTR requires an Immunoassay System that can quantify the cardiac troponin I efficiently with high sensitivity in mouse plasma. The data gained from this instrument will directly help to interpret the drug treatment effect.
System capabilities must include:
- Beaded-based, fluorescence-coupled, single-molecule counting for ultra-sensitivity and low background.
- Low limit of detection at 0.1 picogram/milliliter for Troponin I assay.
- Linear dynamic range of up to 4 orders of magnitude for detection.
- High precision counting with low end average cardiovascular (CV) less than 12 percent for Troponin I assay.
- Small volume (down to 50 microliters) needed for each assay.
Further details are available via Solicitation Number: FDA1161996. The response deadline is February 11, 2016.