Data-driven food allergy diagnostics company, AllerGenis, LLC announced on January 16 that it has entered into a non-exclusive agreement with Luminex Corporation (NASDAQ: LMNX). According to the terms, AllerGenis will have the rights to develop, market and sell its novel precision food allergy diagnostic assay using Luminex’s xMAP® Technology.
The agreement supports the upcoming 2019 commercialization of AllerGenis’ food allergy diagnostic platform, which more than triples diagnostic precision compared to current food allergy tests. AllerGenis’ high-throughput, peptide-bead assay breaks down allergenic proteins into smaller components, called epitopes. It then measures the reactivity of a patient’s antibodies to each epitope to generate a detailed reactivity profile that can provide clinicians a comprehensive solution with accurate information to better assess and manage that patient’s food allergies.
“Adopting Luminex’s bead-based xMAP® technology dramatically increased the power and scope of our food allergy diagnostic,” said Jim Garner, CEO and board member of AllerGenis. “We have been able to scientifically demonstrate the ability to identify food allergies with much higher precision over currently available blood tests. We’re very excited to enter into this agreement with Luminex to bring this much-needed technology to the clinical setting as soon as possible.”
AllerGenis’ peanut allergy assay will be the first product to launch supported by this agreement in the fall of 2019. The company is also developing a pipeline of assays across a wide range of food allergens using its epitope-based technology, as well as novel biomarkers.

Researchers at Vanderbilt University Medical Center and colleagues have identified a gene that increases the risk for a severe and potentially life-threatening reaction to the commonly prescribed antibiotic vancomycin.
Routine testing for this gene could improve patient safety and reduce unnecessary avoidance of other antibiotics, they report.
 “We think this test will be important in the clinical care of patients starting vancomycin and will prevent mortality and short- and long-term complications,” said the paper’s senior author, Elizabeth Phillips, MD.
Vancomycin is commonly given in the hospital or as home intravenous therapy for several weeks in combination with other powerful antibiotics to treat serious and potentially life-threatening bacterial infections.
Within two to eight weeks of initiating antibiotic therapy, however, some patients develop a severe reaction known as DRESS — Drug Rash with Eosinophilia and Systemic Symptoms — characterized by fever, widespread skin rash and internal organ damage caused by an aberrant T-cell mediated immune response to the drug.
When DRESS develops, all treatment is stopped. The mortality rate that results, often from a combination of organ damage, the need for strong immunosuppressants such as steroids and compromised treatment options for the underlying infection, approaches 10 percent.
While the true incidence of DRESS is not known, every year in the United States “hundreds of thousands of patients are at risk,” said Phillips, the John A. Oates Professor of Clinical Research and professor of Medicine, Pharmacology and Pathology, Microbiology and Immunology at VUMC and Vanderbilt University School of Medicine.
For several years, vancomycin has been known to be a common antibiotic trigger for DRESS, however the genetic risk factors predisposing specific patients were not known.
This new finding shows that vancomycin-associated DRESS occurs in patients who carry specific variations in human leukocyte antigen (HLA) genes. HLA genes encode proteins that present foreign peptides (antigens) to T cells (a kind of white blood cell) to stimulate an immune response.
Vanderbilt University Medical Center https://tinyurl.com/y4ukodbb

A Vanderbilt-led research team has discovered genetic variations that increase the risk of heart attack even when patients are receiving a statin drug like Lipitor or Crestor to lower their blood cholesterol.
The finding helps explain why some patients experience a heart attack or the need for coronary revascularization to open blocked heart arteries while taking statins. It suggests that drugs targeting the genetic variations could lower the heart risk in these patients.
The study demonstrates the power of genome-wide association studies and longitudinal electronic health records (EHRs) to find links between genetic variation and disease, said the paper’s first author, Wei-Qi Wei, MD, PhD, assistant professor of Biomedical Informatics in the Vanderbilt University School of Medicine.
Some of the patients were followed for heart disease for up to a decade after starting on their statin drug. The study found that the effect of the genetic variations or variants was independent of how much their cholesterol improved while taking statins.
“People with these genetic variants were at a higher risk for heart disease, even considering those who have ideal cholesterol levels on their statin,” said Joshua Denny, MD, MS, Vice President of Personalized Medicine at Vanderbilt University Medical Center (VUMC) and the paper’s corresponding author.
The researchers searched four sites in the Electronic Medical Records and Genomics (eMERGE) network, a nationwide consortium of experts, biorepositories and electronic medical record systems supported by the National Institutes of Health (NIH), including BioVU, VUMC’s DNA databank.
They found 3,099 people who had experienced a heart attack or the need for revascularization while on statins, and compared them to 7,681 “control” patients on statins who did not experience heart events.
From this comparison, the researchers were able to identify seven genetic variations, called single nucleotide polymorphisms or SNPs, in the LPA locus of genes that were associated with these heart events in patients receiving statin treatment.
The LPA gene encodes apolipoprotein (a), a fatty protein that binds to low-density lipoprotein (LDL), the form of blood cholesterol that is the target of statin drugs. High levels of bound LDL, called Lp(a) for short, is well known to be an independent risk factor for heart disease.
One of the SNPs was highly associated with an increased risk of heart events. When the researchers examined the full EHRs of 11,566 individuals who carried the SNP for more than 1,000 physical conditions, they found significantly higher rates of coronary heart disease and heart attack but not of other diseases.
The approach, called a phenome-wide association study, was pioneered by Denny and his colleagues at Vanderbilt.
“The study highlights the need to consider targeting Lp(a) levels as an important independent factor to reduce cardiovascular risk in patients on statin therapy,” Wei concluded.
Efforts to reduce Lp(a) levels using existing or new drugs could reduce heart events in the proportion of patients on statins who carry LPA variations, he added, although clinical trials would be needed to detect potential side effects and confirm the safety of any such treatment.

Vanderbilt University Medical Centre
news.vanderbilt.edu/2018/05/03/gene-study-spots-clues-to-heart-risk-for-statin-patients/

Hologic announced recently that its Aptima® HIV-1 Quant Dx Assay has received two new CE marks in Europe – for early infant diagnosis (EID) and for testing dried blood spots (DBS).  This means the assay can be used to qualitatively detect HIV-1 RNA as an aid in the diagnosis of HIV-1 infected infants under 18 months old, and to test an additional sample type (DBS) to monitor viral load and disease progression in HIV-1 infected individuals in European and African countries. It is the first and only dual-claim assay for both viral load and early infant diagnosis. The dried blood spot claim is particularly important in the African market as it is a much more stable and easily transportable sample type than liquid blood.
The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of HIV type 1 (HIV-1) on the fully automated Panther™ system. It is intended as an aid in the diagnosis of HIV-1 infection, as a confirmation of HIV-1 infection, and as an aid in the clinical management of patients infected with HIV-1. The Aptima HIV-1 Quant Dx assay may also be used in conjunction with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals.  
“With 25 million people infected with HIV in sub-Saharan Africa alone, there continues to be an urgent need for accessible testing, which is crucial for managing care and reducing the spread of this life-threatening infection,” said João Malagueira, vice president, Europe South and Indirect Markets. “These new product extensions, along with the recent announcement of our Hologic Global Access Initiative, underline Hologic’s commitment to providing accessible testing.  They will enable healthcare providers in resource-limited settings to scale up their HIV testing programmes to meet the 95-95-95 goals set out by the World Health Organization (WHO).”
The Aptima HIV-1 Quant Dx assay was awarded World Health Organization prequalification for in vitro diagnostics using plasma samples on December 21, 2017. This means that the assay meets WHO standards of quality, safety, performance and reliability, and allows global health organizations to consider the Aptima HIV-1 Quant Dx assay for public sector procurement in resource-limited settings.
The Aptima HIV-1 Quant Dx assay is processed on Hologic’s Panther system, an integrated platform that fully automates molecular testing with true sample-to-result automation, adaptable workflow options, and a broad testing menu. The Panther system is designed to be modular and scalable, accommodating the needs of large, centralized labs as well as smaller, decentralized labs. The Panther system offers the highest throughput per square meter of any comparable molecular diagnostic instrument – up to 320 results in 8 hours in less than one square meter of space.
www.hologic.com

Patients with colorectal cancer have the same consistent changes in the gut bacteria across continents, cultures, and diets — a team of international researchers, from University of Copenhagen among others, find in a new study. The hope is the results in the future can be used to develop a new method of diagnosing colorectal cancer.
Cancers have long been known to arise due to environmental exposures such as unhealthy diet or smoking. Lately, the microbes living in and on our body have entered the stage as key players. But the role that gut microbes play in the development of colorectal cancer – the third most common cancer worldwide – is unclear. To determine their influence, association studies have aimed to map how the microbes colonizing the gut of colorectal cancer patients are different from those that inhabit healthy subjects.
Now, researchers from University of Copenhagen, EMBL, the University of Trento, and their international collaborators have analysed multiple existing microbiome association studies of colorectal cancer together with newly generated data. Their meta-analyses establish disease-specific microbiome changes, which are globally robust – consistent across seven countries on three continents – despite differences in environment, diet and life style.
“During disease our microbiome may change. If these changes are consistent in each person getting the same disease then it is a signature of disease. What we show in our study is that the gut microbiome signatures in colorectal cancer seem to be universal. This is despite geography, culture and life style. In the future we hope we can use these signatures as biomarkers and as a diagnostic tool for colorectal cancer,” says Manimozhiyan Arumugam, Associate Professor at the Novo Nordisk Foundation Center for Basic Metabolic Research.
It is the first time a meta-analyses for colorectal cancer has been done on this scale. In the study, the researchers have analyzed and used data from seven cohorts from the countries China, Austria, France, Germany, the US, Italy and Japan.
“We used a rigorous machine learning analysis to identify microbial signatures for colorectal cancer. We validated these signatures in early cancer stages and in multiple studies, so they can serve as the basis for future non-invasive cancer screening,” explains Georg Zeller from the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany.
University of Copenhagen https://tinyurl.com/y4mx25au