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The final survival data from FLAURA establishes osimertinib as front-line therapy for patients with EGFR-mutated NSCLC. Give the best therapy first, experts say.
Medscape Medical News

Results from CheckMate 227 suggest that combination nivolumab and ipilimumab may eliminate the need for chemotherapy in advanced NSCLC, regardless of PD-L1 status.
Medscape Medical News

With the combination of ipilimumab and nivolumab, 50% of patients are still alive after 5 years, a survival rate remarkably higher than that seen with either agent alone.
Medscape Medical News

U.S. federal agents raided genetic testing laboratories, and 35 people were criminally charged in four states in a crackdown on genetic testing fraud that officials said on Friday caused $2.1 billion in losses to federal healthcare insurance programs.
Reuters Health Information

Three medical stories that we didn't cover, explained.
Medscape

Apotex Corp has voluntarily recalled all pack sizes and formats of ranitidine tablets in the US on a 'precautionary basis' after a probable carcinogen was found in other generic Zantac products.
News Alerts

Immune-targeted therapeutics are being used in cancer. Immune “checkpoint inhibition” provides promise for prolonged disease-free patient survival. Use of immune checkpoint inhibitors in cancer has coincided with the onset of immune-related adverse events (irAEs). irAEs are caused by a break in host self-tolerance, which can be deadly. Acute management of irAEs is complicated by difficulty making a prompt clinical diagnosis. The goal is to maximize anticancer benefit while minimizing irAE risk. We currently lack diagnostic tools to assess pretreatment irAE risk and facilitate diagnosis. Current immunologic understanding of irAEs is discussed with an emphasis on how patients with congenital syndromes of T-cell activation may inform this understanding. The prospects of improving diagnostics for and treatment of irAEs are discussed.

Antiphospholipid syndrome (APS) is as an autoimmune disease characterized by thrombosis and/or specific pregnancy-related morbidity associated with persistent antiphospholipid antibodies, namely, lupus anticoagulant and IgG and IgM antibodies to cardiolipin and beta2 glycoprotein I. Optimal antibody detection plays a central role in diagnosis and classification. This review discusses antiphospholipid antibodies helpful for diagnosing APS. It includes the criteria and noncriteria antiphospholipid antibodies, methods for their detection, and challenges for clinical reporting and interpretation. The significance of using specific noncriteria antiphospholipid tests in an integrated diagnostic approach with criteria antiphospholipid makers for the diagnosis and management of APS is also reviewed.

The presence of antinuclear antibodies (ANAs), which include autoantibodies to extractable nuclear antigens (ENAs), in the sera of patients with connective tissue diseases provides useful immunologic and pathophysiologic insight into the nature of their disease. This article discusses the most commonly used diagnostic modalities for detecting and quantitating the presence of ANA: indirect immunofluorescence assay, enzyme-linked immunosorbent assay, and multiplex bead technology, which serve as useful screening tests. We also review testing for autoantibodies to ENAs, which are often helpful to confirm the diagnosis of a specific connective tissue disease.

Low-yield diagnostic testing is common, but machine learning could potentially identify and discourage wasteful testing that may be costly and harmful, researchers say.
Reuters Health Information

This review explores the principles behind and the many uses of thromboelastography and thromboelastometry. How can these diagnostic tests be used in guiding blood product transfusions?
American Journal of Clinical Pathology

The Centers for Medicare & Medicaid Services moves to let more clinicians write progress notes on psychiatric patients and to allow telephone orders for portable X-rays through omnibus rule.
Medscape Medical News

A new trial of autologous mesenchymal stem cells in progressive MS has shown significant benefits vs placebo in several measures of disability.
Medscape Medical News

Metabolic "signatures" in baby teeth can distinguish ADHD from autism as well as cases in which both neurodevelopmental disorders are present, early research suggests.
Medscape Medical News

The recent explosion in our knowledge of the molecular basis of immune regulatory mechanisms has paved the way for rapid developments in immunosuppression, immunotherapy, allergy, autoimmunity, and immunodeficiencies, all of which have impacted the practice of clinical laboratory immunology. The advent of immune checkpoint inhibitors and cell therapies in recent years has led to a surge of interest in clinical immunology. Advancements in lasers, microfluidics, and advanced electronics have resulted in the proliferation of robust and affordable flow cytometry or cell-sorting instruments that can withstand the demands of a clinical lab.

For decades, autoantibody detection has comprised the bulk of clinical laboratory immunology. However, most immune disorders are caused by imbalances in both humoral and cellular immunity. Our knowledge of the immune system has grown exponentially, resulting in new treatment paradigms in immunology. Extensive functional characterization of lymphocyte subsets is routinely carried out in a research laboratories, facilitated by the emergence of high-dimensional analysis technologies for low cell numbers. It will not be long before these approaches enter the diagnostic realm. This chapter outlines emerging trends in laboratory immunology testing with a focus on deep immune profiling or high-dimensional testing modalities.

“With the increasing application of biotechnology to the realm of pharmacology and therapeutics, the types of biological treatments available have significantly expanded. Currently, recombinant proteins, humanized antibodies, or rationally engineered monoclonal antibodies are used on a regular basis in the clinical setting. Moreover, cell-based therapeutics with molecularly rewired antigenic specificities are becoming increasingly common in oncology and are actively being developed for a broad range of diseases. Nonetheless, there has been a significant lag between the development of these technologies and the emergence of assays that can monitor these novel interventions.”

The outcomes of kidney transplantation show a steady improvement with an increasing number of transplantations and decreasing incidence of acute rejection episodes. Successful transplantation begins with a comprehensive immunologic risk assessment and judicious choice of therapeutic agents. In this review, we discuss the trends in transplant immunosuppression practices and outcomes in the United States. We discuss practical testing algorithms for clinical decision making in induction therapy and fine-tuning maintenance immunosuppression. We introduce assessment tools for immune monitoring after transplantation and speculate on future directions in management.

Although the gold standard for diagnosis of immunoglobulin E (IgE)-mediated food allergy is an oral food challenge, clinically relevant biomarkers of IgE sensitization, including serum-specific IgE and skin prick testing, can aid in diagnosis. Clinically useful values have been defined for individual foods. More recently, specific IgE to particular protein components has provided additional diagnostic value. In summary, food allergy diagnostics to evaluate IgE sensitization are clinically useful and continue to evolve to improve evaluation of IgE-mediated food allergies.

Laboratory assays of immune cell function are essential for understanding the type and function of immune defects. These assessments should be performed in conjunction with a detailed history and physical examination, which should guide the evaluation of patients with a suspected immune deficiency. Laboratory assays of immune cell function are critical for assessing and demonstrating the functional impact of genetic mutations. Advances in diagnostic techniques continue to expand the ability of clinicians and researchers to understand the complex immune pathophysiology that underlies these disorders.