Companion and complementary diagnostics for infectious diseases.

Companion and complementary diagnostics for infectious diseases. Expert Rev Mol Diagn. 2020 Feb 07;: Authors: Dailey PJ, Elbeik T, Holodniy M Abstract Introduction: Companion diagnostics (CDx) are important in oncology therapeutic decision-making, but specific regulatory approved CDx for infectious disease treatment are officially lacking. While not approved as CDx, several ID diagnostics are used as CDx. The diagnostics community, manufacturers, and regulatory agencies have made major efforts to ensure that diagnostics for new antimicrobials are available at or near release of new agents.Areas covered: This review highlights the status of Complementary and companion diagnostic (c/CDx) in the infectious disease literature, with focus on genotypic antimicrobial resistance testing against pathogens as a class of diagnostic tests.Expert opinion: CRISPR, sepsis markers, and narrow spectrum antimicrobials, in addition to current and emerging technologies, present opportunities for infectious disease c/CDx. Challenges include slow guideline revision, high costs for regulatory approval, lengthy buy in by agencies, discordant pharmaceutical/diagnostic partnerships, and higher treatment costs. The number of patients and available medications used to treat different infectious diseases is well suited to support competing diagnostic tests. However, newer approaches to treatment (for example narrow spectrum antibiotics), may be well suited for a...
Source: Expert Review of Molecular Diagnostics - Category: Laboratory Medicine Tags: Expert Rev Mol Diagn Source Type: research