According to the description from U.S. Food and Drug Administration, a companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.
Companion diagnostics can：
- identify patients who are most likely to benefit from a particular therapeutic product;
- identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; or
- monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.
If the diagnostic test is inaccurate, then the treatment decision based on that test may not be optimal.
As the leading genetics lab in Taiwan focusing on personalized preventive medicine and early diagnosis, GGA aims to grow its portfolio vertically along the human life cycle by expanding its services from prenatal arena to adult genetics, and horizontally based on the new development such as companion diagnostics which cooperate with pharmaceuticals, medical research centers and so on.
Pharmacogenetics of HCV
This test utilizes a platform for Pharmacogenetics of Hepatitis C virus NS5A developed by collaboration between GGA Corp. and TCM BioTech International Corp.
Hepatitis C is a potentially fatal liver disease caused by the hepatitis C virus (HCV). The disease affects more than 130 million people worldwide. It’s typically spread through the shared use of medical needles by intravenous drug users.
Genotype 1 is the most common HCV genotype. The FDA has approved some New Oral Hepatitis C Drugs, which according to clinical trials, has cured hepatitis C for over 90 percent of patients undergoing treatment. Although such treatment is promising, it is also costly. Genetic testing for HCV NS5A polymorphism is recommended prior to initiation of treatment.
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