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Sony DADC Develops Smart Consumables for Quanterix Simoa HD-1 Analyzer

Quanterix Corporation, delivering the world’s most sensitive single molecule immunoassay measurement for the benefit of human health, recently announced that the Simoa HD-1 Analyzer recently launched by Quanterix uses a “Smart Consumable” designed and manufactured by Sony DADC BioSciences called the Simoa Disc. For use in life science research today and in vitro diagnostics (IVD) markets in the future, the Simoa disc is used to achieve higher levels of sensitivity and precision and is the first diagnostic consumable whose assay technology is based on optical disc formats by Sony DADC.

Fluidigm and Olink Bioscience Bring a New Level of Protein Biomarker Discovery to the Life Science Research Market

Fluidigm and Olink Bioscience have teamed up to enable interrogation of 96 samples across 92 proteins in a single run from one microliter of sample in less than a day.

The two companies will co-market the combination of their respective products — Fluidigm’s BioMarkTM HD System and Olink Bioscience’s Proseek® Multiplex technology — bringing protein research to the Fluidigm platform and Olink Bioscience’s protein detection assays to the high-throughput, high reproducibility and unparalleled sensitivity realm of Fluidigm’s real-time PCR system.

Fluidigm’s BioMark HD System and Olink Bioscience’s Proseek Multiplex technologies provide researchers with the highest throughput multiplexing solution for protein biomarker discovery in the market today. Typically, researchers are limited to working with a few tens-of-protein biomarkers at a time. Using the BioMark HD System with the Proseek Multiplex Oncology I 96×96 Kit, a researcher can simultaneously analyze 96 human samples against a panel of 92 analytes, such as growth factors, inflammatory markers, soluble receptors, or cancer antigens. With the addition of four control analytes (two incubation controls, and extension and detection controls), researchers can now obtain results for up to 9,216 reactions in just a few hours.

The first 92-plex Olink panel, available now, is focused on biomarker discovery for cancer. Panels addressing cardiovascular disease and inflammation are expected to be offered later this year.

“Protein research is so important because these biomarkers are used to monitor health states and predict treatment outcomes in patients. One of the biggest trends in the life sciences industry today is research to uncover biomarkers that can lead to companion diagnostics,” said Simon Fredriksson, Olink Bioscience president and chief executive officer. “Conventional immunoassays have been unable to scale due to increasing antibody cross-reactivity when more and more assays are run simultaneously. Olink’s Proseek Multiplex generates high quality data even in highly multiplexed formats, and using these assays in conjunction with Fluidigm’s BioMark HD System gives protein researchers easy access to unprecedented volume and quality of data.”

The Olink Bioscience assay provides a signal when pairs of antibodies equipped with DNA reporter molecules bind to their targets to create new DNA amplicons. The amplicons are subsequently quantified by high throughput real-time PCR. With PCR’s large dynamic range and superb sensitivity, in combination with Olink Bioscience’s unique protein detection assays, the opportunities are enormous for powerful analysis of multivariate biomarker patterns.

“Analyzing 92 proteins from one microliter of sample enables new biomarker discovery and validation,” said Gajus Worthington, Fluidigm president and chief executive officer. “Many sample sources, including those from biorepositories or model organisms, are limited, and researchers can simply run out before they are able to find useful biomarker panels. The combination of Fluidigm’s BioMark HD System and Olink’s Proseek Multiplex assay represents a robust new tool for the protein research community.”

Fluidigm’s BioMark HD System is a multi-application genomics and proteomics platform that provides results equivalent to the gold standards for every respective experimental approach. The system produces high-quality data from RNA, miRNA and DNA from sample sizes down to the single cell level — and now extends to proteins. The BioMark HD System performs analysis of protein expression, gene expression, copy number variation, SNP genotyping, and digital PCR.

Olink Bioscience’s Proseek Multiplex is a multivariate protein biomarker detection kit based on Olink’s proprietary Proximity Extension Assay (PEA). It uniquely allows multiplexing of immunoassays without compromising assay performance. PEA uses pairs of oligonucleotide-labeled antibodies equipped with DNA reporter molecules to bind to proteins of interest in a highly specific manner, solving the antibody cross-reactivity dilemma that plagues and limits conventional protein assays.

Source: Business Wire

Life Technologies Signs Five-Year Agreement with the FDA

Life Technologies Corporation (NASDAQ: LIFE) recently announced that it has signed a five-year agreement with the Food and Drug Administration (FDA) to accelerate and advance food safety testing of E. coli and Salmonella, two foodborne contaminants commonly associated with outbreaks and/or recalls.

The collaboration consists of three distinctive projects:

  • Life Technologies will design and validate new food safety tests for the detection and identification of foodborne pathogens, with pathogen strains provided by the FDA.
  • Life Technologies will design and validate a complete workflow for food pathogen detection on the Ion PGM™ platform, while optimizing sample preparation methods.
  • The FDA will have the opportunity to evaluate new disruptive technology platforms by Life Technologies for the use in pathogen detection.

Life Technologies will use its bioinformatics resources to independently develop real-time PCR (polymerase chain reaction) assays against unique E. coli and Salmonella targets in collaboration with the FDA. It will then provide the test results for these targets to the FDA for further validation.

The FDA will use Life Technologies’ Ion PGM™ Sequencer to generate whole genome sequence information from defined bacteria, and for strains that will be excluded from detection. Life Technologies’ bioinformatics team will then analyze the genomic information and provide assays or tests to the FDA for further validation and analysis. Whole genome sequences generated under the collaboration will be added to the National Institutes of Health Genbank so they can be accessed by the food safety research community.

“We are excited to be entering this cooperative research and development agreement with the FDA as we have been working alongside them in one capacity or the other for over 10 years,” said Nir Nimrodi, Vice President and General Manager for Food Safety and Animal Health at Life Technologies. “The FDA will call on us, particularly when it comes to developing rapid detection kits. This agreement allows them to have new rapid track and trace products for rapid identification of foodborne contaminants.”

Lastly, the FDA will validate and test Life Technologies’ next-generation sequencing technologies for Salmonella investigations as part of its effort to develop new rapid detection tools that can improve the public health response to future outbreaks.

Life Technologies has a strong history of combating pathogen outbreaks. In 2011, Life Technologies developed a custom assay to accurately detect the highly pathogenic E. coli 0104:H4 bacterium that spread through Europe, killing hundreds of people.

“The assay was developed using samples supplied by scientists at University Hospital Munster, who completed the DNA sequencing and analysis work on the deadly E. coli strain using the Ion PGM™ Sequencer,” said Maneesh Jain, Ion Torrent Vice President of Marketing for Life Technologies. “Now the FDA will validate and test this same technology to understand the molecular relationship within the Salmonella pathogen in the hopes to prevent future outbreaks from occurring.”

The PGM™ offers scientists the simplest and fastest workflow, lowest cost-per-sample, and highest sensitivity for multiple basic and clinical research applications.

Source: Life Technologies

Hyperion Medical Introduces the Sudoscan

Hyperion Medical is recently announced the availability of the FDA approved SudoScan device to the medical community. The SudoScan device is a new solution for Sudorimetry, measuring of the sweat gland function as a biomarker for autonomic nervous system (ANS) function.

PerkinElmer Expands Prenatal Screening Test Offerings, Introducing First Early Onset Preeclampsia Screening Test in the U.S.

PerkinElmer, a global leader in human and environmental health and an innovator in the field of prenatal screening for more than thirty years, announced today the first available early onset preeclampsia screening test in the United States. The PreeclampsiaScreen™ | T1 serum screening test enables physicians to more precisely detect asymptomatic patients in the first trimester of pregnancy who are at high risk for developing the dangerous condition, allowing for earlier identification, management and intervention. Early onset preeclampsia is a potentially serious condition that affects 0.5% of all pregnancies, often contributing more to the pregnant mother’s and baby’s risks of morbidity and mortality than does the late form of the disorder.

“This first of its kind screen is our latest commitment to providing clinicians with new, innovative ways to address some of today’s most challenging prenatal clinical scenarios,” said Jim Corbett, Senior Vice President and President, Diagnostics and Life Sciences & Technology for PerkinElmer. “Together with our recent advances, including offering a non-invasive prenatal test based on cell-free fetal DNA, plus a wide range of prenatal testing from biochemical screening to SNP microarray testing to detect birth defects and chromosome abnormalities, we’re giving physicians effective new tools for patient management.”

According to Dr. Jiri Sonek, MD RDMS, President, Fetal Medicine Foundation USA, and Adjunct Professor, Department of Obstetrics and Gynecology from Wright State University, “Preeclampsia is one of the remaining great challenges in obstetrics. It is a major cause of maternal, fetal, and neonatal morbidity and mortality. Fortunately, some physicians may recommend a simple and inexpensive intervention to reduce the risk of preeclampsia which is available in the form of low-dose aspirin. However, this treatment is effective only if begun early in pregnancy. That is why first trimester screening is such a critical component of preeclampsia prevention.”

Early onset preeclampsia is defined as preeclampsia, a sudden increase in blood pressure and protein in the urine, which leads to delivery of the fetus prior to 34 weeks’ gestation. If found early, options such as increased monitoring, modified activity, bed rest and medication can help reduce or avoid complications related to early onset preeclampsia.

PreeclampsiaScreen™ | T1 is administered during the first trimester of pregnancy through a simple blood test to detect three biochemical markers in the mother’s blood: PAPP-A (pregnancy-associated plasma protein-A); PlGF (placental growth factor) and AFP (alpha fetoprotein) that, when evaluated collectively with personal demographic data, provide an individual risk of developing early onset preeclampsia. Physicians have the option to provide two additional biophysical measurements for their patients — mean arterial pressure (MAP) and uterine artery Doppler pulsatility index (UtAD-PI) – each increasing the sensitivity of the screen when included in the testing protocol.

Source: PerkinElmer