Assays
New blood test to help identify Ara h 6 peanut sensitization. A new test from Thermo Fisher Scientific helps allergists and other medical providers better predict which patients may be at risk for life-threatening sensitization to Ara h 6, a protein component in peanuts that can cause severe allergic reactions in certain individuals. Thermo Fisher’s ImmunoCAP Specific IgE blood test for Ara h 6, part of a line of assays for detecting specific peanut allergen components, has been cleared by the U.S. FDA for in vitro diagnostic use.
Results from Ara h 6 ImmunoCAP testing can act as an aid to help specialists and other clinicians better understand patients’ risk factors as part of a tailored allergy treatment or management plans. In some cases, it could reduce the need for oral food challenges, a testing method where a healthcare professional feeds a patient food in measured doses to see if it triggers an allergic reaction.
Advanced diagnostic capabilities for peanut allergies can contribute to better outcomes for allergy sufferers, especially young children. Patients should consult with their healthcare professional or healthcare provider to get tested for individual peanut components. This knowledge helps the clinician understand potential risks, leads to more informed allergy management, and provides renewed peace of mind for patients and parents.
The newest addition to the ImmunoCAP line of component allergy tests also includes assays for cross-reactive carbohydrate determinants (CCD) and profilins, which are both allergens contained in various plants, pollens, and foods. Sensitization to CCD and/or profilin usually does not cause any symptoms but is due to cross-reactivity with certain plants and pollens.
ImmunoCAP blood testing is the most widely used specific IgE blood test, and its accuracy has been documented in more than 4,000 peer-reviewed publications. The tests can identify allergic sensitization to common environmental allergens—seasonal and perennial, indoor and outdoor—as well as common food allergies such as peanuts, eggs, and milk. ImmunoCAP tests, which are available in most major U.S. laboratories, can be ordered for patients of any age regardless of skin condition, current medication, symptom, disease activity, or pregnancy status.
Immunotherapies
Study links psoriasis treatment and improvement in heart artery disease. Researchers have found that treating psoriasis with biologic drugs that target immune system activity can reduce the early plaque buildup that clogs arteries, restricts blood flow, and leads to heart attacks and stroke. The findings highlight how immunotherapies that treat inflammatory conditions might play a role in the reduction of cardiovascular disease risks. The study was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).
Researchers provided first in-human evidence that treatment of a known inflammatory condition with biologic therapy, a type of drug that suppresses the immune system, was associated with a reduction in coronary artery disease, in particular of rupture prone plaque which often leads to a heart attack.
Psoriasis, a common skin disease affecting 3-5 percent of the U.S. population, is associated with heightened systemic inflammation, which elevates risk of blood vessel disease and diabetes. Inflammation occurs when the body’s defensive mechanism kicks in to ward off infection or disease, but this mechanism can turn against itself when triggered, for instance, by excess low-density lipoproteins (LDLs) that seep into the lining of the arteries.
The resulting inflammatory response can cause blood clots, which block arteries and can lead to heart attack and stroke. Inflammation puts 20-30 percent of the U.S. population at risk for these kinds of events. People with inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, and psoriasis have a much higher rate of cardiovascular events.
Those high rates make worse already troubling numbers: more than 15 million Americans, and many more worldwide, suffer from atherosclerotic cardiovascular disease. Heart attack occurs in 750,000 individuals every year in the U.S.; globally, more than seven million people had heart attacks in 2015.
Opioids
FDA finalizes policy on new buprenorphine treatments for opioid use disorder. The U.S. FDA issued a final guidance, “Opioid Use Disorder: Developing Buprenorphine Depot Products for Treatment,” which outlines the FDA’s current thinking about drug development and trial design issues relevant to the study of buprenorphine depot products, such as modified-release products for injection or implantation. The guidance includes minor changes to the draft document published in April 2018.
Improving access to prevention, treatment, and recovery services, including the full range of medication-assisted treatment (MAT), is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of HHS’ Five-Point Strategy to Combat the Opioid Crisis.
There are currently three FDA-approved drugs for MAT—methadone, buprenorphine, and naltrexone—that have been demonstrated to be safe and effective in combination with counseling and psychosocial support to treat opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also blocks the pleasurable effects of other opioids, making continued opioid abuse less attractive.
When combined with the right treatments and supports, novel formulations or delivery mechanisms described in the FDA guidance—including passive-compliance formulations such as sustained-release depots and implants—can provide effective treatment of OUD, and may result in less misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films.
The guidance outlines ways that companies can more efficiently advance innovations in buprenorphine depot products—from the data needed to support approval, to the specific review pathways that are available to help streamline how sponsors consider their development plans. It also details the types of studies the FDA recommends for buprenorphine depot products that are similar to an approved depot product, as well as buprenorphine depot products with novel features relative to approved depot products.
HIV
Ending the HIV epidemic: a plan for America. Robert R. Redfield, MD, Director, Centers for Disease Control and Prevention (CDC) made the following statement regarding ending the HIV epidemic in America:
“I’m excited that CDC is part of this unprecedented opportunity to end the HIV epidemic in America. The Administration’s plan will deploy the people and key prevention and treatment strategies needed to reduce new HIV infections by 75 percent over the next 5 years, with the hope of a 90 percent reduction within 10 years.
We have the tools to end new HIV infections in this Nation, but they must be applied now. The most recent data suggest that progress in reducing new infections has plateaued, and many communities remain vulnerable to HIV infection. Under this proposed initiative, we will focus on four key strategies to meet the needs of communities with the highest HIV burden: diagnose new HIV infections; treat those with infection rapidly and effectively; protect people from being infected through access to comprehensive prevention and treatment, including medications that can prevent infection; and respond quickly to and stop new outbreaks. To accomplish this, we will accelerate our work with state and local health departments. We will establish HIV elimination teams—for ‘boots-on-the-ground’ support—to ensure communities with the greatest burden make progress. We will listen to people living with HIV, and to public health partners in the most-affected communities, so we reach those in greatest need.
CDC is proud to have been part of the fight to prevent HIV from the very beginning, and we are honored to continue to work with our HHS colleagues on this important initiative. I thank the President and Secretary Azar for their visionary leadership in seizing this opportunity. The time to end the HIV epidemic is now. I have always believed in seeing the possible. Embracing the possible, we will do it together.”
EBV
Binding Site offers recombinant EBV antigens for research and IVD manufacturing applications.Binding Site’s Immunological Group announced the addition of five new recombinant Epstein-Barr Virus (EBV) antigens to its broad offering of products for in-vitro diagnostic (IVD) manufacturing and research applications.
The EBV Capsid Antigen P18; EBV Capsid Antigen P23; EBV Early Antigen P138; EBV Early Antigen P54; and EBV Nuclear Antigen EBNA1, P72 have all been expressly designed for use as integral components within solid phase enzyme immunoassay test procedures, especially ELISA.
All antigens offered are E. coli source-derived recombinant proteins which exhibit exceptional purity levels as a result of exclusive chromatographic manufacturing techniques, while demonstrating exceptional lot-to-lot consistencies and high degrees of activity and specificity. All feature a shelf life stability claim of ten years from the date of manufacture and are offered in a standard-sized 1.0mg filled vial, with larger, bulk packaging configurations available.
