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Product Releases



November 5, 2009--Thermo Fisher Scientific Introduces New Economy Bottles for Laboratory Use

Thermo Fisher Scientific Inc. introduces new Thermo Scientific Nalgene Economy Bottles. These lightweight, cost-effective bottles are the quality choice for light-duty laboratory applications such as containing samples and daily working solutions like buffers and bench reagents. Guaranteed leak-proof, the bottles offer exceptional durability and are chemically resistant.

Nalgene® Economy Bottles are available in either rigid high-density polyethylene (HDPE) or autoclavable polypropylene copolymer (PPCO). Both are excellent for room temperature, refrigerated and freezer use and feature the Nalgene linerless closure system for leakproof performance. Technical support is available to assist in selecting the right resin for research applications, ensuring optimal performance.   

The Economy Bottles are manufactured, assembled and conveniently packaged in an ISO-certified facility. Lot-specific product certificates of compliance are available for quality assurance.

www.thermo.com/economybottles


November 4, 2009-- Aurora Introduces VERSATM Vial Filling Workstation

Aurora announces the launch of the VERSATM Vial Filling workstation. The workstation is a compact, fully automated robotic system capable of consistently dispensing accurate volumes. It turns the tedious, time-consuming, error-prone and repetitive process of filling reagents into a practical and satisfactory one.

As a result, reagent manufacturing companies will meet their strict regulatory standards without a challenge. Manual factors that have limited the probability of meeting these standards, such as handling errors leading to imprecise results are overcome by this unit.  

The VERSATM Vial Filling Workstation has a small foot print and features such as no-splash and no-tips make the instrument cost-effective by saving unnecessary tip and reagent expenses. The adjustable dual-channel ReagentDrop supports a wide range of fill sizes and also allows high-speed addition of the same reagent into two separate vials, simultaneous mixing of separate reagents into same vial or simultaneous addition of separate reagents into different vials.

An optional UV/HEPA hood provides protection from harmful reagents being dispensed and additional protection from contamination.

www.aurorabiomed.com


October 30, 2009--Prometheus Launches ProOncDx Cancer Diagnostics

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announces the nationwide commercial launch of three new cancer diagnostic products: ProOnc TumorSourceDx, ProOnc SquamousDx and ProOnc MesotheliomaDx. Each of these tests is based on recently developed, highly sensitive microRNA technology.

"Prometheus has a long and successful history of providing innovative diagnostics that complement targeted therapeutics to help physicians individualize patient care," says Joseph M. Limber, president and CEO of Prometheus. "Now we are proud to introduce the first three products from our cancer diagnostics portfolio with the launch of ProOncDx. We believe that these highly tissue-specific tests provide more objective and quantitative results than current methods, which may lead to more personalized treatments for patients."

ProOnc TumorSourceDx identifies the tissue-of-origin of a metastatic tumor. The test identifies 25 different tumor types, including colon, liver, brain, breast, kidney, lung, ovary, pancreas, prostate and testis, and measures the expression level of 48 microRNA biomarkers. ProOnc TumorSourceDx uses a proprietary classifier to assign a primary site to the cancer sample based on the microRNA expression in the tumor and may become a critical tool in the detection of cancer of unknown primary (CUP).

ProOnc SquamousDx classifies non-small cell lung carcinoma tumors into two histological groups: cancers of squamous histology and non-squamous cancers. The test measures the expression level of a squamous microRNA biomarker to differentiate patients that have squamous cell carcinoma of the lung from patients that have non-squamous non-small cell lung cancer.

ProOnc MesotheliomaDx is a cutting-edge molecular diagnostic test that uses microRNA to differentiate malignant pleural mesothelioma from peripheral adenocarcinoma of the lung and metastatic carcinomas involving the lung and pleura.

"MicroRNAs are small, non-coding sequences of RNA that are critically important in many biological and pathological processes," says Harvey Pass, MD, professor of Cardiothoracic Surgery and director of the Division of Thoracic Surgery and Thoracic Oncology at New York University Langone Medical Center and its NYU Cancer Institute. "The sensitivity and specificity of microRNA-based diagnostics should enable clinicians to differentiate particular cancer tissues with increased confidence, which may ultimately guide medical oncologists to deliver the safest and most efficacious therapy for their patients."

www.prometheusoncology.com


October 29, 2009--Fletcher-Flora Releases Enhanced Outreach Solution

Fletcher-Flora Health Care Systems Inc. announces the availability of FFlex ePortal Outreach solution, a comprehensive laboratory outreach solution for healthcare facilities, e.g., large/small hospitals, reference labs, physician offices, nursing homes, clinics or other facilities requiring secure remote access to patient lab data.

This Web-based outreach solution can coexist with currently installed HIS or LIS systems and allows clients and physician members to place lab orders from remote locations, review results in real time and generate reports. Features of the product are intended to simplify access to data, improve communication between labs and their physician customers and streamline workflow between multiple sites.

New enhancements in FFlex ePortal Outreach include: enhanced doctors' inbox using a highly intuitive "dashboard" format that serves as a simplified and streamlined launch pad for accessing patient results; nursing homes, group practices or other facilities that send samples to a lab for processing using paper requisitions that can now utilize FFlex ePortal for fast, cost-effective and efficient access to their patient data via the Internet; enhanced Computerized Physician Order Entry (CPOE) makes FFlex ePortal even more flexible for physicians wanting their orders placed and their results routed to and from ancillary sites; new shortcuts to minimize keystrokes and manual effort so physicians can forward results to other ePortal practitioners for consultation and easily communicate with laboratory staff; and improved graphics for all analytical reports showing trend and historical results by doctor and by analyte

An aggressive pricing strategy and key functional enhancements can strengthen the relationship between labs and their clients by improving communication to and from the laboratory, providing real time secure access to patient results and information, and facilitating information-sharing among physician colleagues.

"In today's environment, healthcare organizations want to leverage their existing systems with complementary applications which provide value and increase customer service", says Terry Watson, vice president of sales and marketing of Fletcher-Flora Health Care Systems. "FFlex ePortal Outreach Solution does exactly that."  

Labs also benefit by reducing manual steps in the workflow, improving turnaround times and eliminating paper handling and report delivery. According to Neal Flora, president and CEO of Fletcher-Flora Health Care Systems, "FFlex ePortal Outreach helps labs level the playing field with competing reference labs by providing a simple and cost-effective way to provide customers with access to laboratory results 24 hours a day, 7 days a week, with virtually no operational down time."

In addition to the enhancements made in this newest release of FFlex ePortal, Fletcher-Flora Health Care is rolling out a new aggressive pricing structure to make their outreach product more cost effective and accessible for any facility with multiple locations.

www.fletcher-flora.com


October 28, 2009--Common Sense Introduces Test to Screen for Vaginitis

Common Sense Ltd. has introduced a novel solution in the United States for clinicians who wish to screen women for vaginitis.

Designed for use in doctor's offices, the VS-SENSE™ swab-based test detects within seconds, by color change, elevated vaginal acidity levels associated with Bacterial Vaginosis (BV) and the sexually transmitted disease Trichomonas. The VS-SENSE™ Test has an accuracy rate of more than 90 percent and offers an alternative to time-consuming clinical tests as well as expensive laboratory tests that doctors relied on in the past.

The VS-SENSE™ Test is recommended for use in all cases of abnormal vaginal discharge. The VS-SENSE™ Test may also be used before procedures such as in-vitro fertilization and hysterectomies. If BV or Trichomonas is detected, doctors can recommend treatment and also may wish to delay these procedures in order to achieve the best possible outcome for their patients. Patent protected, the VS-SENSE™ Test received 510(k) clearance by the FDA in August 2009, and is already widely used in Israel and various European countries.

"Doctors love the VS-SENSE™ Test because it is so easy to use," says Amir Karp, Common Sense's director of marketing and business development. "They can now diagnose and treat their patients more accurately and more cost-effectively than ever before and help ensure that their patients enjoy good feminine health." 

www.cs-commonsense.com


October 27, 2009--New 3M Rapid Detection RSV Test Offers Objective Automated Results

Expanding its platform of rapid diagnostic testing, 3M announces the introduction of the 3M™ Rapid Detection RSV Test. RSV, or respiratory syncytial virus, is a respiratory virus that infects the lungs and breathing passages and is a common cause of bronchitis and pneumonia in children under one year.

The Rapid Detection RSV Test is designed to detect the presence of RSV F-protein antigens in nasopharyngeal swab, nasopharyngeal aspirate or nasal wash/aspirate specimens. The test can detect the presence of RSV in 15 minutes or less using the 3M™ Rapid Detection Reader, manufactured by Response Biomedical, which is also used with the 3M™ Rapid Detection Flu A+B Test introduced in 2008. The Rapid Detection Reader is fully automated, which can help prevent misinterpretation of results. 

"RSV, like influenza, can be a serious respiratory illness that, if not properly diagnosed and treated, could have consequences for a very vulnerable population," says Brian Anderson, global marketing manager.  "The Rapid Detection RSV Test helps clinicians quickly and reliably detect infections, which in turn guides treatment decisions. Because it's used on the same instrument platform as the Rapid Detection Flu A+B Test, clinicians will also have the ability to test for both viruses using just one specimen, making it more convenient for patients."

A clinical study conducted by the North Shore-LIJ Health System (NS-LIJHS) Laboratories evaluated the 3M Rapid Detection RSV Test and compared its sensitivity, specificity, positive and negative predictive values to the leading hospital rapid antigen test brand and two conventional methods of diagnosing RSV, R-Mix culture and direct fluorescent antibody staining (DFA). A total of 338 samples were taken from nasal washings and nasopharyngeal swabs. Results showed that for all ages, the 3M Rapid Detection RSV Test demonstrated greater sensitivity for the detection of RSV (86 percent) compared to the leading brand (59 percent) and R-Mix culture (65 percent); like the other tests, it was less sensitive than DFA. In children under six, the 3M Rapid Detection RSV Test was even more sensitive (89 percent) than R-Mix (64 percent) and the leading brand (61percent). 

"The results show that the 3M Rapid Detection RSV Test demonstrated greater sensitivity than the BinaxNOW® brand in detecting RSV in the test population," says Christine Ginocchio, PhD, MT(ASCP), senior director of Microbiology, Virology and Molecular Diagnostics, Department of Pathology and Laboratory Medicine, North Shore-LIJ Health System.  "We further concluded that the Rapid Detection Reader provides laboratorians with objective results that do not require further interpretation while providing data management capabilities, which helps busy hospital laboratories enhance productivity."     

www.3M.com


October 27, 2009--FDA Approves Vitros® Hepatitis B Surface Antigen Assay for Vitros® 5600 Integrated and Vitros® 3600 immunodiagnostic systems

Ortho Clinical Diagnostics announces FDA approval of the VITROS® Hepatitis B Surface Antigen (HBsAg) Assay for use on the VITROS® 5600 Integrated and VITROS® 3600 immunodiagnostic systems. This diagnostic assay enables the consolidation of hepatitis B testing with routine assays on the VITROS® 5600 Integrated System, which will help make labs more efficient in delivering quality results to physicians and patients.

"This approval underscores Ortho Clinical Diagnostics' continuing commitment to providing clinical laboratories with a complete world-class menu on the VITROS® systems," saiys Michael Samoszuk, MD, chief medical officer, Ortho Clinical Diagnostics. "Since the introduction of the VITROS® 5600 Integrated and VITROS® 3600 immunodiagnostic systems, we have successfully released 113 assays and estimate that the complete VITROS® Menu of 114 assays is expected to be available by mid-2010." 

The VITROS® HBsAg Assay eliminates the need for batch testing, decreasing turnaround time and increasing productivity. The assay can be run with high precision and sensitivity, with results readily available in as little as 37 minutes. In addition, the Intellicheck® Technology used on the VITROS® Systems further enhances the quality of the test result by monitoring the integrity of the sample, process and results.

The VITROS® HBsAg Assay is an in vitro diagnostic immunoassay for the qualitative detection of hepatitis B surface antigen in human serum and plasma. It provides physicians with a reliable and quick test for hepatitis B virus (HBV).  It may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at high risk of acquiring HBV during the perinatal period.

The VITROS® Anti-HBs Assay, already available for use on the VITROS® ECi/ECiQ immunodiagnostic systems, is under review with the FDA for approval for use on the VITROS® 5600 Integrated and VITROS® 3600 immunodiagnostic systems. The VITROS® Anti-HIV 1+2 Assay has been co-developed with Novartis Vaccines and Diagnostics Inc.

www.orthoclinical.com