Clinical application of companion diagnostics:Present and future / 中华检验医学杂志

ABSTRACT

The companion diagnostics (CD), which is closely linked to a particular therapeutic product ( including drugs and biologicals ) , can determine patients who are likely to benefit from the treatment, and which patients have significant increased risks of serious adverse reactions to this treatment . With the release of 2014 US Food and Drug Administration ( FDA)′s In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff , the concept , scope, and usage specifications of the CD have become clearer .As the precision medicine and individualized treatment rapidly develops , the CD is progressing from the traditional field of oncology treatment to the treatment and prevention of other diseases.At the same time, the technology of CD is no longer limited to molecular biology test .More biomarkers are gradually being concerned about and the tests to detect them are expected to develop into CD .