Targeted Cancer Therapies Bring New Precision Medicine Tools to Anatomic Pathologists and Clinical Laboratories

FDA is streamlining how new diagnostic tests are approved; encourages IVD companies to focus on ‘qualifying biomarkers’ in development of new cancer drugs It is good news for the anatomic pathology profession that new insights into the human immune system are triggering not only a wave of new therapeutic drugs, but also the need for companion diagnostic tests that help physicians decide when it is appropriate to prescribe immunotherapy drugs. Rapid advances in precision medicine, and the...

FDA’s New Next-Generation DNA Sequencing Platform Intended to Increase Collaboration among Scientists, Pathologists, and Clinical Laboratory Experts

Federal agency hopes its open-source precisionFDA web portal will aid in development of laboratory-developed tests and inform regulatory decision-making One recent initiative launched by the Food and Drug Administration (FDA) to foster the greater sharing of genetic information may be of some value to pathologists and clinical laboratory scientists  who are developing laboratory-developed tests (LDTs) that incorporate molecular and genetic technologies. The FDA unveiled an open-source platform...

New Industry Emerging to Provide Cloud-based Computing Firepower Needed for Big Data Genomic Analyses of Healthcare and Medical Laboratory Information

Cloud-based genetic research networks that facilitate collaboration by stakeholders worldwide may solve the most difficult disease challenges, including a cure for cancer Coming soon to a clinical laboratory near you: cloud-based “big data” genome analysis! A new industry is emerging dedicated to accepting, storing, and analyzing vast quantities of data generated by next-generation gene sequencing and whole human-genome sequencing. There are already examples of academic departments of...