QIAGEN announced on August 1st that its careHPV™ Test, one of the only molecular diagnostics for high-risk human papillomavirus (HPV) designed to screen women in low-resource settings, has been added to the World Health Organization (WHO) list of prequalified in vitro diagnostics (IVDs). HPV is the primary cause of cervical cancer, so screening women for the presence of the virus is a critical aspect for prevention and early treatment of the deadly cancer. The careHPV Test was launched globally in 2010 and through numerous pilot studies has demonstrated to be a more sensitive alternative to cytology and visual inspection based methods for the detection of pre-cancerous cell abnormalities. The WHO’s evidence-based listing is expected to expand the availability of this critical diagnostic tool in countries that rely on the global organization’s list in making purchasing decisions. The WHO Prequalification status will significantly broaden access to HPV DNA testing to areas of the world with a high burden of cervical cancer.
 
“The WHO prequalified IVD listing is a ‘stamp of approval’ for our innovative careHPV Test, and this will encourage authorities to adopt efficient, highly accurate HPV screening for prevention of cervical cancer in settings with limited healthcare infrastructure,” said Thierry Bernard, Senior Vice President, Molecular Diagnostics Business Area, for QIAGEN. “China routinely uses careHPV in rural or low-resource areas, and QIAGEN partners with non-governmental organizations and health ministries in developing countries. We expect the WHO listing to drive further dissemination of this important tool for women’s health.”
 
QIAGEN’s fast, portable and easy-to-use careHPV Test combines the power of advanced molecular technologies with innovative design features for areas lacking consistent electricity, water or a controlled laboratory environment. For example, the system has color-coded, easy-to-understand menus and self-contained reagents. The test tolerates temperature variations that occur in rural clinics lacking refrigeration due to limited electricity or water, and can provide results much faster than traditional laboratory based methodologies. The careHPV Test was developed with support from PATH, an international nonprofit organization, and is manufactured by QIAGEN in Shenzhen, China.
 
“High-quality molecular HPV tests that are easy to run are critical for expansion of cervical cancer prevention strategies in low-resource settings. WHO prequalification of careHPV is excellent news that will help countries to choose the best and most suitable technology for their programs. To achieve higher coverage of at-risk women and make an impact in cervical cancer prevention, we need to move to affordable and cost-effective strategies with HPV testing leveraging self-sampling potentially,” said Dr. Silvia de Sanjosé, Director of Scale-Up project at PATH, a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges.
 
The careHPV Test for low-resource settings is highly complementary with QIAGEN’s digene HC2 HPV Test, the world’s most validated and sensitive diagnostic test for detection of high-risk HPV. The digene HC2 HPV Test is recognized as the “gold standard” in HPV screening and is widely used in developed countries and in large cities in emerging markets.
 
Cervical cancer is the fourth most common cancer among women worldwide, with an estimated 528,000 new cases and 266,000 deaths in 2012, the most recent year for which WHO publishes statistics. An estimated 80% of new cases and deaths occur in developing countries, where awareness of the disease and access to preventive tests and medical treatment is low. In many low-resource areas, cervical cancer has eclipsed breast cancer as the primary cancer killer of women.

Thermo Fisher Scientific and NX Prenatal Inc., a recognized leader in the detection, monitoring and management of pregnancy-related complications using novel exosome-based methods, have entered into a collaboration to develop clinical mass spectrometry-based proteomics assays to monitor fetal health in utero and assess the risk of adverse outcomes, including preterm birth and preeclampsia.
This new collaboration recognizes the challenges faced by medical professionals who have few tools available for noninvasive risk stratification for adverse pregnancy outcomes. By combining NX Prenatal’s NeXosome platform with Thermo Fisher’s leading liquid chromatography-mass spectrometry (LC-MS) instrumentation, the workflows can address the reliability, accuracy and precision of the analytical solutions currently available to clinical scientists.
"Our collaboration with NX Prenatal is aiming to enable us to better evaluate maternal and fetal biomarkers during pregnancy that correlate with adverse outcomes, such as preterm birth," said Brad Hart, senior director, clinical research, chromatography and mass spectrometry, Thermo Fisher Scientific. "The co-development of a commercially available clinical mass spectrometry-based proteomics assay has the potential to provide a diagnostic solution to both clinical scientists and medical professionals offering more confidence in the evaluation of novel biomarkers that can support a safe delivery and healthy future for mother and baby."
"At NX Prenatal, we are developing novel assays and noninvasive early warning systems to detect subtle molecular changes in the maternal-fetal environment, all with the goal of improving the rate of healthy pregnancy outcomes," said Brian D. Brohman, CEO of NX Prenatal. "Our collaboration with Thermo Fisher Scientific brings together our novel NeXosome platform with their leading analytical technology with the goal of optimizing clinical mass spectrometry-based workflows, in an effort to provide the precision necessary for personalized diagnostic solutions to improve health outcomes for both mother and child."
The unique NeXosome technology is used to enrich maternal blood samples for microparticles, such as exosomes, which play key roles in maintaining certain balances between the mother and fetus during pregnancy. Aberrations in these balances have been shown to correlate with the likelihood of adverse pregnancy outcomes. Merging the NeXosome platform with Thermo Fisher LC-MS technology has the potential to generate fast, efficient and accurate data for the analysis of exosome-derived proteomic biomarkers, which may lead to increased information about maternal and fetal health during pregnancy. Ultimately, the analysis has the potential to support obstetrical care decisions in conjunction with traditional clinical assessments. www.thermofisher.com

Researchers at the Johns Hopkins Kimmel Cancer Center have developed a simple new blood test that can detect the presence of seven different types of cancer by spotting unique patterns in the fragmentation of DNA shed from cancer cells and circulating in the bloodstream.
In a proof-of-concept study, the test, called DELFI (DNA evaluation of fragments for early interception), accurately detected the presence of cancer DNA in 57% to more than 99% of blood samples from 208 patients with various stages of breast, colorectal, lung, ovarian, pancreatic, gastric or bile duct cancers in the U.S., Denmark and the Netherlands.
DELFI also performed well in tests of blood samples from 215 healthy individuals, falsely identifying cancer in just four cases. The test uses machine learning, a type of artificial intelligence, to identify abnormal patterns of DNA fragments in the blood of patients with cancer. By studying these patterns, the investigators said they could identify the cancers’ tissue of origin in up to 75% of cases.
Blood tests, or so-called “liquid biopsies” for cancer detection typically look for mutations, which are changes in the DNA sequence within a cancer cell, or for methylation, a chemical reaction in which a methyl group is added to DNA, says senior study author Victor E. Velculescu, M.D., Ph.D., professor of oncology and co-director of the Cancer Biology Program at the Johns Hopkins Kimmel Cancer Center. But not all cancer patients have changes that are detectable using these methods, he says, and there is a great need for improved methods for early detection of cancer.  
DELFI, he says, takes a different approach, studying the way DNA is packaged inside the nucleus of a cell by looking in the blood at the size and amount of DNA from different regions across the genome for clues to that packaging.  
Alessandro Leal, M.D., a lead author of the study and a Ph.D. candidate at the Johns Hopkins University School of Medicine, explains that the nuclei of healthy cells package DNA like a well-organized suitcase in which different regions of the genome are carefully placed in various compartments. By contrast, the nuclei of cancer cells are more like disorganized suitcases, with items from across the genome thrown in haphazardly.   
 “For various reasons, a cancer genome is disorganized in the way it’s packaged, which means that when cancer cells die they release their DNA in a chaotic manner into the bloodstream,” says Jillian Phallen, Ph.D., a lead author on the study and a Johns Hopkins Kimmel Cancer Center postdoctoral fellow. “By examining this cell-free DNA (cfDNA), DELFI helps identify the presence of cancer by detecting abnormalities in the size and amount of DNA in different regions of the genome based on how it is packaged.”  
The researchers caution that the test’s potential must be further validated in additional studies, but if that happens it could be used to screen for cancer by taking a tube of blood from an individual, extracting the cfDNA, studying its genetic sequences and determining the fragmentation profile of the cfDNA. The genome-wide fragmentation pattern from an individual can then be compared with reference populations to determine if the pattern is likely healthy or derived from cancer.  
Robert B. Scharpf, Ph.D., a senior author on the study and an associate professor of oncology, says that because the genome-wide fragmentation patterns may reveal differences associated with specific tissues, these patterns, when found to be derived from cancer, can also indicate the source of the cancer, such as from the breast, colon or lung.  
DELFI simultaneously analyses millions of sequences from hundreds to thousands of regions in the genome, identifying tumour-specific abnormalities from minute cfDNA amounts, says Scharpf.   
Using DELFI, investigators found that genome-wide cfDNA fragmentation profiles are different between cancer patients and healthy individuals. Stephen Cristiano, a lead author on the study and a Ph.D. candidate in the Johns Hopkins Bloomberg School of Public Health, says that in cancer patients, fragmentation patterns in cfDNA appear to result from mixtures of DNA released from both blood and tumour cells, and show multiple distinct genomic differences with increases and decreases in fragment sizes at different regions.
John Hopkins Medicinehttps://tinyurl.com/yyph9y6e

Even tiny amounts of viruses can have disastrous consequences. RNA identification can reveal the type of virus present. A fast and sensitive technique based on optical detection has now been outlined. Scientists from Germany and Finland have demonstrated the binding of an RNA target to a probe made of gold nanorods and a DNA origami structure. Chirality switches triggered by binding can be measured by circular dichroism spectroscopy.
Identifying the pathogen-often a virus-that is troubling a patient is among the biggest challenges in healthcare. Viruses responsible for Zika fever, AIDS, and hepatitis C contain mutating RNA sequences. Physicians need to know quickly which type of virus their patients have acquired, but current techniques based on multiplying RNA are costly and time-consuming. Now, Tim Liedl from Ludwigs-Maximilians-Universität in Munich, Germany, and his colleagues, have developed a fast detection strategy based on nanoplasmonics, DNA origami, and an optical readout.
Light can induce plasmonic waves in nanosized metal structures smaller than the wavelength of the incident light. This resonance may lead to strongly enhanced light emission even from nanoscopic structures-a feature that is highly interesting for biosensing applications. Liedl and colleagues have created a nanosized sensing probe for RNA molecules.
The probe, a nanosized apparatus made of DNA and gold nanorods, was assembled by the so-called DNA origami technique, which exploits the specific interactions of the DNA bases to fold and glue together single strands in any desired form. The authors constructed two bars of parallel DNA helices loosely connected through a hinge in the middle of the bars. Gold nanorods were placed on top of each of the crossed bars. Both crossing arms were supplied with functionality at their ends: the scientists attached one single DNA sequence complemented with a blocking strand to one arm, and the complementing DNA sequence to the other. In the presence of target RNA, which could be a typical viral RNA sequence, the blocking strand would leave its DNA in favour of RNA hybridization, and both single DNA sequences would complementarily form a double strand whereby the two arms of the cross are pulled together. This structural change introduces chirality to the probe.
Chirality can be detected with circular dichroism. And indeed, the structural changes triggered by the RNA binding induced a circular dichroism signal detectable with a CD spectrometer. Concentrations as low as 100 picomolar of the target RNA were recognized, according to the authors. The scientists hope to establish this technique in lab-on-a-chip systems where few steps are required for sample preparation and low-cost miniature devices lead to sensitive results. Preliminary results on serum from blood with added viral RNA were promising.
The authors admit that the detection limits are still not low enough to be clinically relevant. However, they believe improvements should be possible; including, better protection of the nanosensors from serum proteins, a change to better resonating plasmonic metals, and expansion of RNA recognition sites. This could make the technique a promising diagnostic tool that is not necessarily limited to viral RNA.

MarketScreenerwww.marketscreener.com/news/Viral-RNA-Sensing-Optical-detection-of-picomolar-concentrations-of-RNA-using-switches-in-plasmonic–27285028/

The global Treponema Pallidum (or Syphilis) tests market is projected to reach $462m by 2028, growing at a Compound Annual Growth Rate (CAGR) of 2.99% between 2018 and 2028, according to GlobalData, a leading data and analytics company.
The company’s latest report, ‘Treponema Pallidum Tests – In Vitro Diagnostics Tests Analysis and Forecast Model’ reveals that North America and Asia Pacific will be the fastest growing regions with CAGRs of 3.28% and 3.44%, respectively, during the forecast period.
In many countries, the devices used for primary syphilis screening are changing and higher priced products such as chemiluminescence immunoassays and enzyme-linked immunosorbent assays are increasingly being employed. These newer devices are capable of high-throughput testing and enable institutions to reduce labor costs.
Alison Casey, Medical Devices Analyst at GlobalData comments: “A number of different factors influence growth of the Treponema Pallidum tests market; these include testing of infection and suspected infection cases as well as screening of pregnant women, anonymous sperm donations, whole blood donations, and source plasma donations.”
Barriers to market growth include declining rates of live births and whole blood donations, which are occurring in many countries and geographical regions.
Casey concludes, “While the rising global incidence of syphilis is expected to drive growth of the Treponema Pallidum Tests market, this is just one factor that must contend with multiple other variables that work together to determine future trends of this highly complex in vitro diagnostics market”