- Rapid and highly sensitive detection of biomarkers, such as proteins and specific DNA sequences.
- Label-free photoacoustic (PA) tomography, including PA microscopy, nonlinear PA, and PA nanoscopy.
- Magnetic manipulation of nanoparticles, design of magnetic poles, magnetic force optimization.
Diagnosing Heart Attack: Technical Problems with Serious Health Ramifications
Each year, over 8 million people visit emergency rooms in US hospitals with symptoms of chest pain. Of them, about 10% have suffered heart attacks (acute myocardial infarctions). However, approximately 95% of these patients cannot be diagnosed with simple clinical evaluation and an electrocardiogram test. Uncertainty delays treatment and this delay often has adverse clinical consequences. Rapid and highly accurate testing and diagnosis are crucial.
Upon suffering a heart attack, there are slowly released into the patient’s blood stream increasing amounts of cardiac troponin I (cTnI). The levels of cTnI must often be measured repeatedly over time in order to reach a precise diagnosis.
This process is prolonged by the low sensitivity of current assays. With a minimum level of detection of 10–30 pg/mL and a discriminatory value above 40–80 pg/mL, they cannot detect heart attacks early on. Hours may be required for cTnI levels to reach these discriminatory values. And consequently, the time required for an accurate diagnosis can be 6–9 hours after the onset of symptoms—and longer still if stress testing is required.
This protracted delay leads to substantial over-admission, delays in treatment for other patients, and consumption of health care resources. In fact, admission time accounts for almost 75% of the average cost per patient with symptoms suggestive of heart attack.
To improve current diagnostic capabilities and increase specificity, several companies (e.g., Singulex, Backman Coltour) have developed high sensitivity assays with less than 2 pg/ml level of detection and an approximately 10 pg/ml discriminatory value, but only one such assay has been commercialized, and none has been approved for clinical use in the US. Such high sensitivity tests performed in series with shorter time intervals, could halve the time needed to evaluate patients, but even when they are available, they are carried out only in advanced laboratory settings; and so the blood specimen must be sent to the lab before it can be processed and tested—an additional step with has a high time cost that all but nullifies the benefits of high sensitivity assays.
Dr. Danielli’s Solution
Based on his patented technology, termed Magnetic Modulation Biosensing (US patent 8,465,989), Dr. Danielli aims to develop a high sensitivity, point-of-care (POC) device that can measure low concentrations of cTnI directly from whole blood samples. This device will reduce the time required or rule out an AMI to within 2–3 hours leading to improved care at lower cost for ~8 million people each year and a reduction in ED congestion. Clinical adoption of the device could spur development for other medical applications that could benefit from point-of-care, high sensitivity biomarker detection, including detection of head injuries biomarkers, viruses etc.