By AMANDA PEDERSEN
Medical Device Daily Staff Writer
Faster results. Better accuracy. Reduced cost.
Those are three things CardioGenics (Mississauga, Ontario) hopes to offer through its point-of-care (POC) cardiac diagnostic technology.
Founded in 1997 by cardiac diagnostic test pioneer Yahia Gawad, MD, CardioGenics was recently acquired by JAG Media Holdings (Boca Raton, Florida) through a reverse merger.
Gawad, CEO of CardioGenics, told Medical Device Daily that speed of diagnosis is important when physicians are dealing with possible heart attack patients because they need to decide quickly how they are going to treat the patient, if they are going to be aggressive or use a more conservative therapy.
"For every hour you delay treating the patient it costs three lives, so the time is extremely important," Gawad said. Equally important, of course, is the need to base that treatment decision on a sound diagnosis, he added.
According to CardioGenics, the average time it takes for a heart attack patient to receive ER medical attention is 3.2 hours from the start of chest pain. The average turn-around time of lab-based test results is 2.8 hours, while the minimum time to detect a heart attack using today's lab-based immunodiagnostics is 4.5 hours from symptom onset, the company said.
CardioGenics says its QL Care Analyzer represents a "quantum leap" in the existing POC immunoassay technology the equivalent of the shift from portable CD players to iPods. In just six steps, the QL Care Analyzer provides printed medical lab quality results in less than fifteen minutes.
Gawad said that the company's initial target for the device is emergency rooms, chest pain clinics, and cardiac care units. But the device itself is portable and battery operated, he said, so ultimately CardioGenics envisions it being in ambulances as well.
The single-use cartridge QL Care Analyzer is the size of a portable CD player, features an intuitive user interface touch screen, and is capable of storing patient data for up to five thousand individuals, the company said.
CardioGenics expects to submit a 510(k) application for the QL Care Analyzer to the FDA in about 12 to 14 months testing for troponin I, a protein that is integral to cardiac muscle and its blood level measures the presence and severity of a heart attack.
Looking ahead to a pipeline of future POC products, CardioGenics believes that the device cartridge can ultimately be adapted to run any number of immunoassay tests. There are roughly 200 different immunoassays for HIV, cancer, thyroid conditions, etc., that are currently performed by lab-based analyzers, the company noted.
CardioGenics' other lead product is a line of magnetic beads, consumable test reagents that are used in 90% of medical lab analyzers. While most magnetic beads are dark (and, therefore, less light reflective), CardioGenics says it has developed a process for silver coating magnetic beads, thereby making them more reflective and capable of delivering sensitivity five-to-ten times higher than competitive products in the chemiluminescence testing space. The beads are also markedly less expensive to produce than competing products, the company noted.
Gawad said that in addition to providing faster, more accurate diagnosis, that its technology could reduce healthcare costs. With the availability of this POC test, costs associated with delayed medical care such as prescription of first-line heart attack drugs, and avoidable hospital admissions would be reduced, the company said.
According to CardioGenics, Gawad created the original "gold-standard" cardiac test as director of clinical research at Spectral Diagnostics (Toronto).
CardioGenics completed its reverse merger with JAG Media Holdings in August (Medical Device Daily, Aug. 4, 2009). Gawad said that the funds raised in the merger and the access to funds in the public domain will help CardioGenics accelerate its product through the approval process.
The company's goal in developing the POC diagnostic is to deliver data as good as a laboratory. Gawad said the device, which was developed in house, uses the most sensitive technology available today, which he says is "really important."
Gawad noted that the closest competing technology is a device developed by Biosite (San Diego), a company that was acquired in 2007 by Inverness Medical Innovations (Waltham, Massachusetts).
Similar to CardioGenics' technology, Biosite's Triage Cardiac Panel promises to deliver rapid, actionable information to aid in the diagnosis of acute myocardial infarction, according to the company. Biosite says the test provides a rapid, quantitative measurement of CK-MB, myoglobin, and troponin I to aid in the diagnosis of heart attack.
According to Biosite, its test also: provides simultaneous cardiac marker results from whole blood in roughly 15 minutes; enables triage decisions in under two hours when used with accelerated protocol; enables faster diagnosis of patients with nondiagnostic ECG; rapid, provides accurate rule out of heart attack; decreased length of stay in emergency department; is designed for compatibility with busy emergency departments and physician practices; offers simple one-step testing; is compact and portable ; requires low maintenance; and has built-in quality control features.
Amanda Pedersen; 229-471-4212
Published November 12, 2009