Taiwan based V-CHECK, Inc. is a company committed to promoting global women’s health. Through solid research experiences in translational medicine and professional product development processes, the team identifies effective biomarkers, applies appropriate detection platforms, and develops high quality in vitro diagnostic products for women’s diseases.
Endometriosis is a common gynecological disorder where the endometrial tissue grows outside the woman’s uterus. Although the pathological mechanism remains to be studied further, one of them is retrograde menstruation, which causes the debris of the endometrial tissue to cause cysts (chocolate cysts if ectopic occurs in the ovary) or adhesions. In fact, infertility and cancerization are related to endometriosis with 38% of the cases leading to infertility. The pathological outcomes can be summarized into (1) Tissue adhesion, which is characterized by sticky fallopian tubes and ovaries that prevents ovulation through the formation of a retroverted uterus. (2) Chronic inflammation, which directly affects the quality of ovum, the chance of fertilization, and implantation. Furthermore, 1% of it will become endometrial or ovarian cancer. Therefore, early diagnosis and treatment of endometriosis play an important role in women’s health.
Research Team at Taipei Medical University Develops isoAAT Kit for Early Diagnosis
Clinically, the diagnosis is mainly achieved through imaging (such as vaginal ultrasound, MRI), physical examination (such as vaginal and rectal vaginal endoscopy), invasive laparoscopy as well as pathological examination. However, due to the limitations of these procedures, it is difficult to diagnose early endometriosis and this causes a delay in treatment. Currently, the CA-125 biomarker may be used as an indicator for early detection, but its low sensitivity and specificity cannot accurately detect the condition.
V-CHECK, Inc. a Taiwan based company led by Professor Vivian Yang of Taipei Medical University, aims to solve the bottleneck of endometriosis detection. Since 2002, the research team has been screening for biomarkers. They collected about 1,000 cases from clinical trials, and in 2006, identified “isoAAT”, a serum protein highly associated with endometriosis, and designed its specific antibodies. A two-and-a-half-year National Research Program for Biopharmaceuticals (NRPB) clinical study was conducted in 2012. Double-blind trials that evaluated the effectiveness of isoAAT as a biomarker found that its concentration did not fluctuate with the menstrual cycle and is positively correlated with the condition. According to this clinical study, isoAAT was up to 92% sensitivity, 91% specificity, 75% positive predictive value, and 98% negative predictive value in patients with endometriosis at mild and moderate stages. There is currently no in-vitro-diagnostic method that can detect early endometriosis. The discovery of isoAAT is expected to solve this issue and determine the severity of the disease from the outside in a non-invasive way.
Personalized Treatment Relies on the Early Precision Detection Tools
Endometriosis is a disease with a high recurrence rate in women in reproductive age. Medication is currently the first line of treatment, including NSAIDs, oral contraceptives, gonadotropin antagonists (GnRH agonist, GnRHa); However, the side effects caused by drugs need to be carefully evaluated. For example, the first-line drugs are estrogen and progesterone combined oral contraceptives that have a risk of thrombosis. Progestin oral contraceptives may be accompanied by irregular uterine bleeding, amenorrhea, weight gain, emotional changes (such as depression) and bone loss. Besides, long-term use of GnRHa may cause menopause symptoms such as osteoporosis. On the whole, the clinical drug treatment for endometriosis requires physicians to evaluate its substantive effect.
Laparoscopy has been used as the gold standard along with histology to confirm the diagnosis and evaluate the disease severity. Also, clinicians may remove the adhered endometrial tissue during laparoscopic operation but 35-55% of the cases recur within a year. Furthermore, this invasive operation may damage the ovary if the outgrown endometrial tissues adhered. Therefore, it remains a point of debate whether the laparoscopy is an appropriate intervention for endometriosis, especially for patients who also consider having a baby.
The isoAAT test of a specific protein may be able to make up for the missed lesions in MRI diagnosis, and the low sensitivity of CA-125 detection, thus assisting physicians to make more accurate clinical diagnosis and treatment choices. For example, similar to ultrasound imaging that determines other diseases such as uterine fibroids, and uterine disease that also leads to menstrual pain, isoAAT can accurately determine whether the cause of the patient is endometriosis. Subsequently, clinicians could assess the results and opt for effective drugs, laparoscopy or other appropriate treatment strategies.
From Taiwan to Global – V-CHECK Focuses on Precision Diagnosis of Endometriosis
The V-CHECK team enhances women’s awareness of self-health management through research and development of effective diagnostic tools. Starting from Taiwan and based on TMU’s prior research, the team has developed an in vitro diagnostic test for endometriosis and established ISO13485 certification to build high-quality and standardized production procedures. In the future, they are seeking innovative technology and the in vitro diagnostic medical device to get approved by the national health regulation department of the US FDA, Taiwan FDA, EU, China, and other countries. By establishing cooperative relationships with different medical centers around the world, the V-CHECK team is planning to conduct multi-site and multi-centered clinical trials, and verify product accuracy and sensitivity in different populations. It is anticipated that the novel biomarker isoAAT will be verified and recognized by health and regulatory authorities in more countries. Through more data and evidence collections, isoAAT could become a standard endometriosis indicator and the isoAAT test could be the best choice providing a convenient and effective in vitro diagnostic tool for women with endometriosis.
The ultimate goal of the V-CHECK team is to diagnose endometriosis at the early stage so that patients can receive immediate treatment, which will reduce the cost and burden of medical treatment and prevent endometriosis caused infertility due to delayed diagnosis.
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