Can ERA be easily mimicked or duplicated by other testing companies?

Endometrial Receptivity Analysis (ERA) is our uniquely developed genetic screening service, patented in 2009. Recently, other genetic screening services with similar names such as ER“?” or “?”RA, are being increasingly seen in the market. Without considering the issue of patent infringement, this article is going to discuss whether it is possible for other companies to develop genetic screening services that are technically similar to ERA.

1. Can genetic testing be easily mimicked or duplicated?

Before specifying whether genetic testing can easily be mimicked or duplicated, it is important to understand that there are only two types of genetic testing: DNA testing and RNA testing.

2. Most of the existing genetic testing is DNA testing

DNA, which exists in every single cell and constitutes our body, is the “blueprint of life” that possesses the information for cell, tissue and organ formation. Human DNA is basically the same in every individual with only 0.1% variation; this tiny difference contributes to the diversity among different people.

Inherited from the parents and remaining almost unchanged throughout life, DNA can be utilized to investigate one’s biological predisposition, including the risk of developing lifestyle-related diseases, susceptibility to drug side-effects, physical fitness and metabolic capacity. Data obtained from DNA testing are useful for tailoring measures to prevent diseases and to select suitable and effective therapeutic treatments in the same way that cosmetic products are chosen by us according to our skin types and conditions. In the clinical field, DNA testing is widely adopted in noninvasive prenatal screening tests, pre-implantation genetic diagnoses and precision cancer medicine (categorization of cancer, prognosis and evaluation of treatment efficacy etc.).

In principle, DNA testing is relatively simple both quantitatively and qualitatively, as long as machines (next-generation sequencers) and solutions are properly prepared and staffs are well trained. Therefore, the hurdle of mimicking or duplicating DNA testing is rather low. When a new DNA testing method arises, mimics or duplicates will soon appear in the market. Factors that distinguish the quality of DNA testing services among testing companies include validation of the test efficacy in large-scale, multinational clinical trials, and whether or not there are clear recommendations for the patient included in the test results.

3. RNA testing can hardly be mimicked or duplicated

RNA testing is basically the analysis of gene expression levels. RNA is transcribed from DNA, the blueprint of life, and it is translated into proteins that build up our bodies, support movement and maintain homeostasis. RNA expression levels vary with time and cell types. For example, RNA expression patterns are different between skin cells, muscle cells, and neural cells. Therefore, the status of our body can be assessed using these distinct patterns.

For instance, the RNA expression levels of genes A-K are shown in the figure above. The expression pattern depicted in the blue bars belongs to normal tissue while the expression levels depicted in the orange bars belong to cancer tissue. . By studying these patterns, we can determine whether one is suffering from cancer or not. In other words, the more complicated the biological reaction is, the more genes are involved and the more difficult the analysis is.

Below is the RNA expression pattern used in our ERA analysis. In the case of ERA, when it was first developed 10 years ago, 238 of 30,000 genes in the whole human genome were known to be related to implantation and they were selected to develop our unique assessment of endometrial receptivity.

As more than 200 genes are involved, analysis cannot simply be carried out manually; it is essential to employ AI in order to handle Big Data. We developed a specialized statistical analysis algorithm to analyze expression patterns of multiple genes, and the accuracy of this algorithm was further optimized through training with a large number of clinical samples.

The difficulty of gene expression pattern analysis or RNA testing lies in the process of analysis rather than in the test itself. Our company has trained the algorithm using more than 100,000 clinical samples, and now the endometrial receptivity can be determined precisely in a 12-hour scale. On the other hand, some companies may include fewer genes in the test or adopt a simpler technique called RT-PCR instead of Next-Generation Sequencing in order to lower the cost. However, such practices inevitably lower the accuracy of the analysis as well. For us, the quality and accuracy of RNA analysis should never be compromised, no matter what the price is.

Our vision is to provide accurate testing technique and service

My previous job was to support genomic research and commercial genetic testing services in Asian countries, including Japan. I realized that RNA expression analysis is always the most challenging task. Therefore, testing services derived from RNA expression pattern analysis are rarely seen in the market.

Although ERA just made a debut in the Japanese market 2 years ago, it has been adopted by more than 200 clinics in Japan. Not only that, ERA has also drawn attention from all over the world because of its great contribution to fertility treatment. It is understandable that other testing companies are trying to strategically develop similar services, but the outstanding accuracy and precision of ERA cannot be easily reached within a short period of time. We are worried to see the emergence of cost-saving services of questionable quality, which put precious embryos at risk.

ERA is a patented technique that is uniquely developed by our company Igenomix, and we keep on pursuing perfect accuracy and precision. If you want to obtain the most reliable and accurate endometrial receptivity assessment in the market, our ERA service is strongly recommended.

Author: Andy Chang

• Bachelor in Nuclear Engineering, National Tsing Hua University, Taiwan
• Doctor in Biological Sciences, Kyoto University, Japan (research theme: radiation-induced DNA damage, DNA repair enzymes)
• Postdoctoral researcher, School of Medicine, University of Maryland (research theme: DNA repair system)
• Business Development Manager, clinical diagnostic laboratory CombiMatrix KK
• Technical Director and APAC Business Development Director, microarray specialist Affymetrix Japan
• EMBA, Temple University (top of the class 2017)
• Representative, Igenomix Japan; APAC Business Development Director, Igenomix