CEO Column

A Word from Tan Hong: China’s Immunodiagnostics from Zero to One, ET Healthcare’s Troponin Stacks Up Amongst the World’s Eight Heavyweights

Since its inception, ET Healthcare has strived to develop Troponin reagents. However, the technical barriers amounted so high, that of the three times we tried, two we called it quits; finally, the last attempt proved fruitful, to the tune of a leading world-class product.

In June 2017, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) released the latest high-sensitivity Troponin list. There are currently eight heavyweights in the world. Which eight? Roche, Abbott, Siemens, bioMérieux, Mitsubishi, OCD, Singulex, and ET Healthcare.

That’s right – ET Healthcare is amongst the top eight heavyweights in the world!

This marks the first time that an in-vitro diagnostic reagent, developed and manufactured in China has been invited to the adult table. We are not talking about ordinary diagnostic reagents here, rather immunoassays yielding the highest level of immunodetection in the world – high-sensitivity Troponin!

High-sensitivity Troponin cannot be self-defined. The internationally accepted standard is to detect at least 50% of the normal population’s Troponin concentration, and the CV% at the 99th percentile must not exceed 10%. Troponin reagents that do not meet these two criteria are not high-sensitivity.

ET Healthcare’s high-sensitivity Troponin is unique in that it can be used not only in serum or plasma, but also in whole blood. This is very meaningful for emergency department and chest pain centers.

I am sincerely proud of the achievements of the ET Healthcare team!

A Word from Tan Hong: How can we achieve High-sensitivity Troponin?

At an exhibition in Qingdao last March, I saw manufacturers in Guangdong and Beijing launch their own “high-sensitivity” Troponin assays. Most of the reagents utilized lateral flow techniques. Worth noting, there was a conspicuous Japanese product copy-cat that frightened me. We spent a great deal of effort developing our Pylon’s high-sensitivity Troponin-I assay, and suddenly several other companies obtained their hs-TnI registration permits on outdated POCT platforms…

Later that year, at the CMEF exhibition held in Hongqiao, Shanghai, I once again inquired into the “high-sensitivity” Troponin produced out of Nanjing, claiming to be the only true domestic hsTnI product aside from two imported European giants. How is this claim supposed to make others at the Qingdao exhibition feel?

The IFCC updated its list of high-sensitivity Troponin assays in June of last year. I couldn’t find any of the manufacturers in Guangdong, Beijing, or Nanjing, but rather, it was ET Healthcare listed as the sole China representative. If you carefully study the technical parameters of several domestic “high-sensitivity” Troponin reagents, you have no choice but to admire the boldness of these manufacturers.

So, how do I recall the beginning of our hs-TnI research and development? In fact, initially, I was only aware of contemporary Troponin. After diligently researching for several years, I still found myself focused on the performance indicators of contemporary Troponins. Soon thereafter, we invited Allan Jaffe and Alan Wu to join ET Healthcare as technical advisors. They enlightened our team that the world is on the precipice of the “high-sensitivity” era.

ET Healthcare’s philosophy is not simply to do something for the sake of it, but rather, when doing something, to be the best in the world and promote the advancement of our industry. So, after reading a few academic papers on hs-TnI and gaining a little knowledge on the subject, I used a whiteboard pen to list the technical parameters of the Pylon high-sensitivity Troponin assay on our laboratory glass window. Even though my knowledge was limited at the time, “learn as you go” is the way of life at ET Healthcare, and we initiated the high-sensitivity project without hesitation. In order to achieve high-sensitivity, we re-optimized the technology and invented a new detection concept. The entire R&D process was fraught with difficulties and hardships. However, by the beginning of 2016 our arduous journey began yielding results as we had basically reached the goal of high-sensitivity.

Troponin is the best indicator for the diagnosis of myocardial infarction; with high-sensitivity Troponin, CK-MB, Myo, etc. are no longer necessary. But, because of its high technical difficulty, this assay can be described as the most precious gem in the crown of the immunodiagnostics realm. In the internationally immunodiagnostics world, only several large companies have developed this product. ET Healthcare remains hard at work, constantly improving product performance, and we look forward to more progress and milestones this year. I hope that in the near future, real domestic high-sensitivity Troponin reagents will be available for the benefit of both doctors and patients.