Focus: 69th AACC Annual Scientific Meeting & Clinical Lab Expo

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Liquid biopsy is a new technology for detection and analysis of biomarkers in blood or other body fluids without the need of invasive procedures. One important analyte is cell-free circulating DNA (cfDNA). The main challenges in working with cfDNA are the low concentration (1 - 50 ng/ml) and the high degree of fragmentation of cfDNA (< 500 bp). An additional complication is that the circulating tumor DNA only accounts for up to 20 % of the total cfDNA. Therefore processing higher sample volumes, typically in the range of several milliliters, is required.

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As companies and institutions from across the globe converge on San Diego for the annual ACCC meeting there is a common thread between them all – there is a drastic need for more trained professionals.

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SynAbs is proud to announce strategic deal with successful company Dianova. Dianova has already demonstrated a huge knowledge and expertise in monoclonal antibodies and will consequently extend its catalogue with unique mAbs references from SynAbs. Under the terms of the agreement, Dianova will have access to unique portfolio of rats and guinea pigs mAbs to address German territory needs in R&D and IVD fields.

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The SME of Besançon bought Diaclone in 2012, then participated in the creation of SynAbs Belgian start-up in 2015. Business is booming.

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The Diatron, global provider of hematology and clinical chemistry analyzers, will display their Aquila 3-part differential hematology analyzer (60 samples /hour throughput) at the upcoming AACC Meeting in San Diego, California on the 1-3 of August, 2017.

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SJK Global Vanilmandelic Acid (VMA) Assay is a quantitative immunoassay for measuring VMA in human urine.

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Findings presented at the American Society for Microbiology’s ASM Microbe conference show that the ultra-sensitive Clostridium difficile toxin A/B assay in development for use on the Sgx Clarity™ system offers excellent sensitivity and may be a critical tool for improving the diagnosis of this life-threatening infection. The Sgx Clarity system is a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.

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Yaskawa Motoman offers track-based specimen processing solutions that improve speed, capacity and accuracy for labor-intensive, high throughput areas of the clinical diagnostic lab. These fully integrated pre- and post-analytic automation solutions can enable high throughput with minimal staffing.

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Singulex, a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of protein biomarkers, today announced it has applied the CE Mark to its ultra-sensitive troponin I assay (cTnl), the first offered on the Sgx Clarity® system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.

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Singulex, Inc., the creator of Single Molecule Counting immunodiagnostic technology, announced the closing of a $50 million senior-secured debt facility with Perceptive Advisors. The capital secured will fuel the continued growth of Singulex and its industry-changing Single Molecule Counting platform, which delivers unprecedented ultra-sensitivity and utility to some of the most prevalent and costly diseases.

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Singulex, Inc., the creator of Single Molecule Counting immunodiagnostic technology, is expanding clinical evaluation of the Sgx ClarityTM system at clinical research sites across Europe. With multiple clinical research studies currently underway at a site in Spain and two sites in the United Kingdom, leading researchers and cardiologists across Europe recognize the potential value and utility of the in vitro diagnostics (IVD) platform to help bring greater sensitivity, accuracy and utility to understanding disease status, particularly in heart disease.

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The Sarstedt PVS 1625 is a comprehensive, modular laboratory automation system for pre- and post-analytical processing. Independent from an analytical platform, the PVS 1625 is customized per facility needs for any size lab and every need. Modules are available for bulk or rack loading, identification, decapping, sorting, aliquoting, and recapping with either a push or screw cap. Aliquots can be made directly into compatible screw cap tubes and immediately recapped for send-outs or capped post-analysis for archiving. The PVS 1625 is compatible with most analyzer racks and common tube types and dimensions.

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Sarstedt’s Microvette® capillary blood collection systems accommodate volumes of 100µl to 500µl with a choice of two collection techniques.

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The Sarstedt S-Monovette® is an innovative, enclosed multiple-sampling blood collection system. Recent studies conclude that the system may be used to significantly reduce hemolysis in blood samples due to shear stress associated with traditional vacuum tubes. Compared to untreated syringes, S-Monovette® tubes contain a range of additives and can be processed directly with no transfer, maintaining a closed connection. Ask how our Point-of-Care solutions can reduce cartridge rejection and limit blood contaminates.

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Sarstedt Minivette® POCT devices are designed for the precise and hygienic collection, transfer, and subsequent dispensing of small capillary blood samples for point-of-care tests. Blood is easily collected via capillary action into the collection capillary of the Minivette® POCT. The sample is held securely in the capillary during transfer without spills and then dispensed onto the test field or into a micro tube with a slight push of the opposing integral piston.

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The Sarstedt HCTS2000 MK2 accessions and sorts closed primary sample tubes rapidly and accurately to 7 user-defined target bins. Optional extension modules add 5 bins each for up to 22 targets. The instrument can process up to 2000 tubes per hour, and tubes can be loaded and unloaded with minimal interruption. Users can select 10 different sets of sorting rules, and the HCTS2000 MK2 can sort with or without LIS connection. It is compatible with a broad range of tubes, regardless of manufacturer.

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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and HbA1c Gen. 3 assay has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

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Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Influenza A/B & RSV test for use on the cobas® Liat® System. Roche is the first manufacturer to extend the value of highly accurate CLIA-waived molecular testing beyond flu A/B and strep A to include Respiratory Syncytial Virus (RSV), a cause of more than 80% of acute lower respiratory tract infections in infants under one year of age.

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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyzer series, the cobas e 801 module, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack. With this clearance, Roche is the first IVD company in the U.S. to provide the next generation Troponin testing for patients as an aid in the diagnosis of myocardial infarction, enabling clinicians to more accurately identify patients experiencing a heart attack.

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Hexokinase (HK, EC 2.7.1.1) is an enzyme that phosphorylates hexoses (six-carbon sugars), forming hexose phosphate. In most organisms, glucose is the most important substrate of hexokinases, and glucose-6-phosphate is the most important product. Hexokinase can transfer an inorganic phosphate group from ATP to a substrate.

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IBM Watson Health (NYSE: IBM) and Quest Diagnostics (NYSE: DGX) today announced the launch of IBM Watson Genomics from Quest Diagnostics, a new service that helps advance precision medicine by combining cognitive computing with genomic tumor sequencing. Memorial Sloan Kettering Cancer Center (MSK) will supplement Watson’s corpus of scientific data with OncoKB, a precision oncology knowledge base to help inform precision treatment options for cancer patients.

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Harvard Pilgrim Health Care now offers physicians Data Diagnostics®, a point-of-care health analytics technology from Quest Diagnostics (NYSE: DGX) and Inovalon (NASDAQ: INOV) that is designed to help close costly gaps in care and improve health outcomes.

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In 2016 the team at Pharmozyme made a break through. Developing a proprietary platform, gene amplification enzymes were re-envisioned for the next generation of amplification and sequencing technologies. Taq Polymerase, a major player in biotechnology, was the first product to be produced in Pharmozyme’s new platform.

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Proteometech focus on Innovative technology and Novel bio-products. All of our products, Allergy-Q, ImmuneCheck IgG and TriCheck, are world-first products and are being reputed a great success in Korea and the exporting countries.

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Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, commemorated its 50-year anniversary by awarding $150,000 in total grants to three organizations that share its goal to improve healthcare: The American Red Cross, the National Ovarian Cancer Coalition and Autism Speaks.

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Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced that it has been named one of the "World's Most Admired Companies" for 2017 by Fortune.

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TriCore Reference Laboratories announced today that David G. Grenache, PhD; has been selected as its first Chief Scientific Officer, effective September 2017.

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A pain point many clinical labs will have to tackle in increasing priority over the next few years is cost reduction. As healthcare continues its transition from fee-for-service payments to value-based payments, facilities are anticipating a considerable decrease in Medicare reimbursements for clinical lab tests. With reimbursements shrinking and costs for everything from labor and specimen collection to transportation and logistics rising, labs are challenges to find new and better ways to maintain an acceptable cost structure while delivering the customer service and quality the market demands.

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LGC Maine Standards1 announces the release of VALIDATE® IBC linearity and calibration verification kit. The VALIDATE® IBC kit, in a human serum matrix, evaluates Total Iron Binding Capacity (TIBC) and Unsaturated Iron Binding Capacity (UIBC). Each VALIDATE® IBC kit, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range of most chemistry analyzers. Each kit is liquid and ready-to-use. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.

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GS200 is a multi-functional benchtop clinical chemistry analyzer with a throughput up to 150 T/H. It features 24-hour non-stop cooling, stable heating for reaction, bilateral LIS etc., it is a compact chemistry solution for small laboratories and a back-up tool for mid-to-high end laboratories.

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PA54 is a semi-auto analyzer for quantitative determination of specific proteins in blood, urine samples, including HbA1c, HS-CRP, CRP, ASO, CYS-C, RF, mALB, D-Dimer, IgM, IgG, IgA, C3, C4, etc. It's an ideal instrument designed for medium or small labs or backup analyzer in large labs.

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Imegen is a top Spanish Company for genetic analysis and molecular diagnostics services and kits. We offer A to Z flexible services and products including Sequencing, Arrays, MLPA, Real-time PCR, Digital PCR, NIPT, etc. Our internally developed sequencing technique, NextGeneDx, is based on NGS and differentiates by providing high resolution and coverage >100X of all coding regions of the targeted genes with specificity and robustness comparable to Sanger. Our recently launched Digital PCR kit, QUIMERA, is cutting-edge kit to follow up on transplant patients analysing haematopoietic chimerism. In addition to maximum precision and sensitivity, QUIMERA requires neither standard curves, nor pre-transplant samples, nor replicas. We are currently expanding on the international market and looking to collaborate with partners/ distributors in various regions and countries.

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KNF introduces the new solenoid-driven FL 10 diaphragm pump for OEM customers. With a nominal liquid flow rate of 100 mL/min, FL 10 features bi-directional flow-tightness without additional check valves, IP 65 protection, simple linear flow rate adjustment, a maintenance-free expected lifetime of 10,000h, and other key cost-saving attributes.

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Introducing new KNF NMP 03 micro gas pump—starting at a lightweight 11g and measuring just 12.9 mm wide and 24.2 mm in length—this diminutive pump delivers very consistent, linear transfer from a few milliLiters to 500 mL/min.

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GE300 is an easy-to-use, color touch screen electrolyte analyzer with throughput of 60 samples per hour based on ISE method. Auto calibration, sampling, cleaning to assure accurate results. Maintenance-free and long life electrode is another competitive feature to make it stand out and satisfy the customers.

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KT-6400 is an innovative hematology analyzer with a large touch screen, built-in thermal printer and huge storage capacity. It is a diagnostic system combined with reliable hardware and intuitive software, which is a perfect solution for small labs and clinics.

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KT-6610 is an innovative, economic, compact hematology analyzer using advanced tri-angle laser scattering, flow cytometry technology to deliver cost-efficient 5-part white blood cell differential results. It is a perfect solution for small labs and clinics, which have limited space and budget, but request accurate hematologic results.

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Follett LLC, an industry leader in medical-grade refrigerators and freezers, announces the release of an enhanced feature set in all of its upright refrigerators and freezers. The new touchscreen control package puts every essential feature at your fingertips – from data collection and alarms, to an electronic locking system.

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Dx-Sys Inc. (Booth # 1356) has developed an ultra-sensitive, Lateral Flow Point of Care diagnostic test for Glial Fibrillary Acidic Protein (GFAP), a potential biomarker for Traumatic Brain Injury (TBI). The test is a one-step quantitative immunochromatographic assay which can be performed in 60 minutes using a Time Resolved Fluorescence Strip Reader with a sensitivity of < 1 pg/mL of GFAP in human serum. The POCT can also be performed on a Qiagen’s standard Fluorescence strip reader for Europium chelates with a sensitivity of 10 pg/mL for GFAP.

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Diener Precision Pumps, the leading manufacturer of precision piston pumps and gear pumps has been Engineering Your Flow for Clinical Laboratory instruments since 1994. The company prides itself on its Global Engineering of Excellence based in Lodi, CA and its precision manufacturing facility located in Embrach, Swizterland. A perfect marriage of renowned Northern California innovative engineering with Swiss quality produced products.

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San Diego biotech announces CE-IVD marking of blood and saliva collection tubes for molecular diagnostics

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News provided by Ortho Clinical Diagnostics

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DiaSorin (FTSE Italia Mid Cap: DIA) announced today that they have received clearance from the US Food and Drug Administration to market the Simplexa C. difficile Direct Assay for the detection of Clostridium difficile (C. difficile).

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Data Innovations (DI) today announces the launch of version 8.15 of Instrument Manager (IM), the latest version of the leading middleware product. This version provides technology enhancements to our Hot Backup solution and introduces an additional option called High Availability.

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Olympus, a global technology leader in imaging solutions, will have its experts available for product demonstrations at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo July 30 - August 3 in San Diego. The Olympus booth (#3433) will be exhibiting the BX53, BX46, and CX23 microscopes, as well as the DP74. For more information or to schedule an interview and hands-on demonstration with a product expert, please email Kristin Schaeffer at [email protected].

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Olympus, a global technology leader in imaging solutions, will have its experts available for product demonstrations at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo July 30 - August 3 in San Diego. The Olympus booth (#3433) will be exhibiting the BX53, BX46, and CX23 microscopes, as well as the DP74. For more information or to schedule an interview and hands-on demonstration with a product expert, please email Kristin Schaeffer at [email protected].

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When Clippard invented miniature regulators in 1962, the MAR Series became very popular as a simple, robust, and cost-effective regulator in a small package with exceptionally long life. As regulator applications continue to increase, Clippard is meeting the demand with the newest addition to the reputable regulator line. The new DR-2 Series provides greater accuracy and repeatability (±0.15 psi) while maintaining the same flow and performance characteristics as the MAR regulators in a small, sleek package.

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When Clippard invented miniature regulators in 1962, the MAR Series became very popular as a simple, robust, and cost-effective regulator in a small package with exceptionally long life. As regulator applications continue to increase, Clippard is meeting the demand with the newest addition to the reputable regulator line. The new DR-2 Series provides greater accuracy and repeatability (±0.15 psi) while maintaining the same flow and performance characteristics as the MAR regulators in a small, sleek package.

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Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global provider of life science research and clinical diagnostic products, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IH-1000 blood typing instrument along with approvals for a wide range of associated gel cards and reagents for the U.S. blood typing market. The system offers full automation and walk-away reliability, allowing laboratories to more efficiently manage their blood testing workload.