Clinics in laboratory medicine
-
Genetic research heralds a new therapeutic approach to pain management. Increasing literature demonstrates individual genetic vulnerabilities to specific pain types and mechanisms, partially explaining differing responses to similar pain stimuli. ⋯ Family history and genotyping promise to play an important role in the future approach to pain therapies. As advances continue in the genetics of pain and analgesia, pharmacotherapy will depend more on an individualized, targeted approach and less on empiricism.
-
The scope of FDA's jurisdiction over laboratory-developed tests (LDTs), and whether FDA has such jurisdiction at all, has been a heavily debated issue over the past several years. If FDA moves forward with its guidance, or Congress takes action to reform LDT and IVD regulation, a fundamental question that needs to be answered is how to divide activities regulated by FDCA from those regulated by CLIA. In this article, we consider FDA's authority to regulate LDTs and the policy implications of regulation, and discuss an idea for a fact-driven framework to distinguish FDCA- and CLIA- activities.
-
Deep sequence analysis of the vaginal microbiome is revealing an unexpected complexity that was not anticipated as recently as several years ago. The lack of clarity in the definition of a healthy vaginal microbiome, much less an unhealthy vaginal microbiome, underscores the need for more investigation of these phenomena. Some clarity may be gained by the careful analysis of the genomes of the specific bacteria in these women. Ongoing studies will clarify this process and offer relief for women with recurring vaginal maladies and hope for pregnant women to avoid the experience of preterm birth.
-
Human immunodeficiency virus (HIV) primary infection occurs at mucosa tissues, suggesting an intricate interplay between the microbiome and HIV infection. Recent advanced technologies of high-throughput sequencing and bioinformatics allow researchers to explore nonculturable microbes, including bacteria, virus, and fungi, and their association with diseases. ⋯ In this review, the authors focus on microbiome in HIV infection at various mucosal compartments. Understanding the relationship between microbiome and HIV may offer insights into development of better strategies for HIV prevention and treatment.
-
Review
Perioperative management of patients receiving new oral anticoagulants: an international survey.
New oral anticoagulants (NOACs) are increasingly replacing standard anticoagulants. These new drugs have been recently introduced in clinical practice, and specific knowledge regarding preoperative interruption, anticoagulation assessment, and reversal therapies is needed. In this article, 3 main areas related to perioperative NOACs management are discussed: (1) physicians' knowledge, (2) current practices, and (3) perspectives to improve management of patients treated with NOACs.