Heart attacks: acute infarction detection can be accelerated by new marker products: Renovated and reinvented troponin products are complemented with a new method: GPBB (Glycogen Phosphorylase BB) based cardiac tests

CEO Ernest Kapetanovic (Diagenics International Corp., Woburn, MA / Essen, Germany) sees improved prognosis and treatment options for patients

Boston/Essen, September 30th, 2009. – Time is critical in cardiac diagnosis. This has been clear since decades. But now two independent solutions revive the chances for a better, faster cardiac diagnosis, leading to improved options for patients and doctors.

Just a few weeks ago before the European Society of Cardiology (ESC) annual meeting opened it´s doors in Barcelona, two studies presenting a new generation of troponin products hit the media.
The new products aim to accelerate clinical diagnosis, compared to the established “late marker” troponin. We take a closer look at the new products and at a separate approach, an innovative new GPBB based product and the underlying method, which again adds more diagnostic options for the wellfare of the patients by improving early knowledge on ischemic events.

Current status cardiac diagnosis: many patients show up in the emergency room which are suspicious of infarction, but only some are finally confirmed as heart infarctions

One method complementing ECG (electrocardiogram) measurements are the biochemical cardiac blood markers including troponin, a protein of the heart muscle which is measured to detect infarctions.Troponin based tests are now globally established since more than a decade in the cardiology community worldwide. The decisive and important disadvantage during the obviously very time critical treatment of infarctions is the high time delay in detection of infarctions with troponin. It´s simply too late.
The usual procedure is that many patients with chest pain, the first sign of heart infarctions will show up in the emergency room, but only some of them will finally be diagnosed with a “real” infarction.
That leaves the cardiologists and emergency room doctors with the permanent question to differentiate between those who need immediate and intensive medical attention on the one hand, and those who do not need (at least cardiac) treatment.

Old Troponin Tests are late in diagnosing infarctions

Only late, up to 4-6 hours after the first typical sign of an infarction (chest pain) a diagnosis based on established troponin assays is possible for a higher fraction of patients. But this chest pain onset also let´s the clock start to count the hours which will lead to the initially reversible and finally irreversible loss of cardiac tissue.
However, troponins, although being late markers, always had the important advantage of being highly heart specific, which ensured that positive troponin values for potential heart patients actually showed and documented infarctions.

The new generation of „faster“, more sensitive troponin tests: just faster, or even better?

The new troponin test generation promises a faster diagnosis. This acceleration is important both for the doctor and the patient. The current 4-6 hr delay until the first troponin detections were possible, could now be reduced to 3 hours by using the new test products. This reduced detection time also has disadvantages. The new tests bear the problem of the diminished accuracy and hereby reduce the former very high specificity of the method.
In order to reduce the time to troponin base diagnosis, the markers had to be made more sensitive. But this higher sensitivity can lead to wrong results. A so called false-positive shows a putative heart infarction which actually has another cause. In an article published on theheart.org the authors of the study on new troponin products clearly state this problem.
The advantage of new, more sensitive troponin tests is the early detection of very low troponin values, but this includes the risk of false positive results. The new markers, according to the authors, have to be used in highly specialized chest pain units only and patients which have certain other symptoms have to be excluded before using the new troponin tests. This is the only way specificity remains high.
Other experts mention the need to look closely at the details of each new product separately. Cardiac marker expert and IFCC member Fred Apple recently published an article on new troponin products where he mentions the need need for a “Scorecard” to categorize and understand the now even larger array of troponin based systems. According to Dr. Apple, now not all new troponin assays are equal: there are “contemporary” and “high sensitive assays”. “The season is here, now, to provide an evidencebased scorecard for educating clinicians and laboratories on the strengths and weakness of each cTn assay used in clinical practice, and in applied and translational studies and trials” summarizes Fred Apple in his publication.

A new method is correlated with oxygen deficiency (ischemia): GPBB

This could raise the question, how to best combine speed, sensitivity but also specifity in diagnosing the time critical infarction. A newly developed, innovative tests could be part of the solution here. The method is very sensitive early after chest pain and at the same time is highly specific.
Experts have already known about this new marker for some time which is based on the enzyme with the acronym GPBB. GPBB stands for glycogen phosphoralyse BB, which has been developed by the US company Diagenics and is distributed as a laboratory and point-of-care test system.
The new test is based on an ischemia marker. Ischemia is induced by reduced or complete block of blood circulation in the affected tissue. The resulting low oxygen, in turn, activates GPBB, a specific enzyme which can break down the energy reserves of the heart (glycogen) also in low oxygen situations. The enzyme, once activated by low oxygen, is released into the blood stream and can be detected there by highly specific antibodies. Thus, new new GPBB method is actually associated with the early warning and rescue system of the heart cells.
From the perspective of patients and doctors a very good competiton of both methods (Troponin and GPBB) will speed up progress in the clinical settings: both methods try to be heart specific and heart sensitive early after chest pain.
Diagenics CEO Ernest Kapetanovic regards this striving for the best diagnostic options as very positive: “Patients health and prognosis should always be our guideline here. Therefore, we welcome the technical improvements of classical troponin products and the related study results” says Ernest Kapetanovic. „However, it should be mentioned that the new systems still are based on a necrosis marker. Even if they are now faster than the old products, they can still only react after heart cells are irreversibly damaged and have died.” Says Mr. Kapetanovic and also emphasizes the general difference to ischemia based markers on which the DIACORDON product family is based.

Both early and specific: GPBB / DIACORDON

The current studies indicate that an early detection of ACS/infactions is possible by using the new marker GPBB/Diacordon.Also the specificity of this early diagnosis remains high.
„A high specificity can be reached starting in the first hour after chest pain onset by using our GPBB/DIACORDON point-of-care test. “ says Ernest Kapetanovic.
For Samir Yastas, Member of the Board of Diagenics International Corporation, the early diagnosis has to be the focus of attention: “Early detection of specifiy oxygen reduction by using the DIACORDON POC (Point-of-care test) and ELISA can speed up diagnosis and better informed decisions. The method based on an ischemia marker will still be earlier than the classical “late marker” Mr. Yastas says “because we do not have to wait until the first cells have been irreversibly damaged and have died”

Reinfarction- improvement of the diagnostic methods

Regarding the physiology of GPBB, the new marker should enable physicians to diagnose also secondary infarcts, called reinfarctions. Troponin in general remains highly elevated in the blood for several days after the infarction, whereas GPBB will return to it´s base value earlier.
Diagenics International Corporation now starts a new study in cooperation with the IHF (institute for heart infarction research). This study aims to coordinate systematic and unified statistical clinical protocols to further analyze the early detection of heart infarctions in more details and on a broad basis.

A new cardiac agenda for the patients: a resulting faster diagnosis

The good news is that both methods will contribute to the patient receiving a faster, better informed and earlier treatment. The typical so called “cardiological dilemma” to be quick and exactly with the diagnosis treating the confirmed infarctions fast without missing or overdignosing patients is now moving up in the agenda of the responsible persons in research, medicine and healthcare policy.
Currently, Diagenics is also working with one of the research teams which published the data on the new troponin assays (Senior Researcher Prof. Blankenberg, Mainz). The new GPBB assay will thus be directly compared to the classical and new troponin products, using the same patient samples (blood, plasma) as in the studies mentioned by Keller et al.

DIAGENICS is a biopharmaceutical company located in Woburn (Boston), MA (USA) with its European headquarters in Essen, Germany. Our unique business model strives to build a Bridge from Science to Business™.

In this way we aspire to a leading position in the diagnostic field. We are currently focussing on the detection of heart infarction through a new and patented heartmarker.

DIAGENICS constantly observes scientific results and compares them with the needs of market and economy.

DIAGENICS International Corporation
Alfredstr. 98
45131 Essen
Tel: +49 201 289 990 0
Fax: +49 201 289 990 13
E-Mail: info@diagenics.de
http://www.diagenics.com

This release was published on openPR.