FDA clears immunoassay system for sale in the USA
On May 24, 2011, Siemens Healthcare Diagnostics announced that it received U.S. Food and Drug Administration (FDA) clearance to market its IMMULITE 2000 XPi immunoassay system in the United States. The newest member of the IMMULITE product family offers the largest automated immunoassay test menus available. Several hardware and software solutions enhance workflow efficiency and productivity for medium- to high-volume clinical laboratories, including, among other features, an automated rack loader which enables users to load patient samples without pausing the system.
Additionally, this analyzer system delivers Internet-based remote monitoring capabilities and an improved user-friendly touch-screen interface.
Released outside of the United States in 2009, the Siemens system has received positive feedback. According to Mark Harrison, senior biomedical scientist at The Yorkshire Clinic in West Yorkshire, U.K., “We upgraded to the system less than one year ago … a significant benefit for our lab has been the AutoStart function, because it automatically runs the daily maintenance and quality control checks. It has helped us receive 90% of the QC results by 10 a.m., allowing for faster time to the first patient result.”
“For medium- and high-volume laboratories, optimizing efficiency and consolidating testing processes continue to be among their biggest priorities,” says Dave Hickey, CEO of Siemens Healthcare Diagnostics' Chemistry, Immunoassay, Automation, and Diagnostics IT Business Unit.
For information, visit www.siemens.com/healthcare.
Urinalysis workstation available following recent FDA 510(k) clearance
IRIS International, manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial labs worldwide, and a provider of personalized diagnostics testing services, announced that, following recent 510(k) market clearance on March 24 from the FDA, it has commenced U.S. commercial activities with the shipment of its iChemVELOCITY automated urine chemistry analyzers in combination with its iRICELL urinalysis workstations to three U.S. hospitals.
Thomas Warekois, President of the Iris Diagnostics Division says, “This completes a Diagnostics Division strategic incentive to have a common, fully integrated automated urinalysis product line delivering productivity and clinical performance to hospitals and clinical reference laboratories across the globe.”
Ken Waters, vice president of Sales America at Iris Diagnostics, says, “This next-generation of our automated urinalysis systems combines our series of iQ200 automated urine microscopy analyzers with the iChemVELOCITY automated urine chemistry analyzer in two new product configurations — iRICELL Plus with optional iWare software and iRICELL PRO.”
The company is expanding its core imaging and morphology expertise into related markets and is developing applications in hematology and body fluids.
The company recently acquired a high-complexity CLIA-certified molecular pathology lab offering differentiated, high-value molecular diagnostic services in the field of personalized medicine.
For more information, visit www.proiris.com.
Biomarkers adopted into HCC surveillance program
Wako Diagnostics, a division of Wako Chemicals USA, received 510(k) clearance from the FDA to market the uTASWako i30 instrument with alphafetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests in the U.S. The AFP-L3 and DCP assays are intended for use by healthcare professionals as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC). It has been demonstrated that HCC surveillance programs for at-risk patients improves applicability of curative therapies. Incorporating these biomarkers as additional surveillance tools will improve the chance of detecting early stage HCC.
Peter Panfili, PhD, general manager of Wako Diagnostics, says, “We expect that the adoption of these biomarkers into HCC surveillance programs will complement the use of imaging technologies to bring about the desired earlier detection and treatment of liver cancer.” Microfluidics has enabled miniaturization and integration of key analyzer processes for the uTASWako i30: sampling, mixing, separation, and detection on microfluidic chips. The system uses immunochemical and electrophoretic techniques to achieve rapid, accurate, precise, and sensitive assay results.
The bench-top automated instrument is designed for efficiency and ease of use in a clinical chemistry setting. With automated calibration and quality control, it requires minimal setup time.
For more information, visit www.wakodiagnostics.com.
Philadelphia cancer center chooses technology to deliver on promise of personalized medicine
Fox Chase Cancer Center, a cancer research and treatment institution, recently entered into an agreement with Life Technologies that will underpin a new program to provide next-generation sequencing analysis of solid tumors. The agreement is a foundational element in the planned Cancer Genome Institute at Fox Chase, a facility that will foster new discoveries and treatments and establish the institution as a leader in developing personalized medicine strategies for cancer care.
“With this agreement, we are taking the next major step in delivering on the promise of personalized medicine for all cancer patients,” says Michael V. Seiden, MD, PhD, president and CEO of Fox Chase Cancer Center.
The Institute's focal initiative, expected to begin in late 2011, will be the launch of a discovery project using selected tumors, followed by clinical service to be made available to participants from throughout the U.S. In this second phase, it is expected that by using Life Technologies' genomic sequencing technology, investigators will analyze a patient's tumor genome to provide his oncologists with additional information that can be used to guide treatment or steer the patient into appropriate new drug trials.
The broad goal of the initiative is to combine several institutional resources and a multidisciplinary team — including scientists and clinicians — to evaluate the ways that genomic sequencing can be used in patient management. Fox Chase clinicians will be able to assess a genomic analysis of a patient's tumor compared to his normal tissues. The service will utilize Life Technologies' sequencing and analysis platforms, including the SOLiD system, Ion Torrent semiconductor sequencing, and novel biological information technology systems for analysis of genomic data. It is expected that with appropriate resources and after rigorous testing and validation studies, genome sequencing can become a broadly used diagnostic tool integrated into the standard management of patients with cancer.
The technology will enable the Cancer Genome Institute at Fox Chase to create a genomic knowledge database that will build on Fox Chase's already substantial Biosample Repository to add a critical additional layer of new knowledge about the genetic information in individual patient tumors. With patient consent, information linking the patient's tumor genotype, the oncologist's recommendation of targeted therapy, and the patient's clinical outcome will be made available to the research and clinical oncology community at large, while protecting the identity of the patient.
“Efforts linking the latest genome technologies to the needs of individual patients exemplify the leadership role that Fox Chase Cancer Center plays in the search for a cancer cure,” says Philadelphia Mayor Michael Nutter. “Through institutions like the Fox Chase, Philadelphia continues to build upon an international reputation not only as center for innovative science, but also excellence in patient care.”
Florida Hospital adopts new automated lab solution
Florida Hospital in Orlando is improving its laboratory testing capabilities with new state-of-the-art equipment from Roche Diagnostics that is designed to help labs increase their testing capacity and deliver reliable results with greater efficiency.
Opened in 1908, Florida Hospital is a faith-based institution focused on providing whole person care. It is one of the largest not-for-profit hospitals in the country, caring for more than a million patient visits per year – that is more than any other hospital in the country, according to the American Hospital Association. The more than 2,000-bed system is comprised of eight hospitals and 18 Centra Care locations throughout Central Florida.
Florida Hospital initially expects to process approximately 3,000 to 4,000 test tubes daily and provide about 2 million to 3 million individual test results per year. The system will handle the vast majority of the most common laboratory tests run by the hospital. As the Central Florida community grows and the hospital cares for more patients, the new equipment will enable the lab to handle the increased demand for diagnostic tests without slowing down the testing process.
The Roche system combines three components: the new cobas 8000 modular analyzer series, the cobas p 701 post-analytical unit, and the Roche/Hitachi MODULAR PRE-ANALYTICS sample handling system. The high-volume, automated system will allow patient blood samples to pass through the testing process untouched by human hands.
“The high volumes of testing we do make it essential that we have the highest-capacity and most efficient laboratory equipment available,” said Patrick O'Sullivan, the hospital's laboratory director. “This automated system not only ensures high levels of productivity and workflow but also standardizes test results across all Florida Hospital systems.”
The new system also will help ensure reliable and consistent results for repeat testing. The refrigerated post-analytical unit stores 27,000 test tubes, automatically retrieves them when additional testing is needed, and automatically discards tubes that are no longer needed.
“We congratulate Florida Hospital as it continues to demonstrate its commitment to innovation in patient care,” says Jack Phillips, president and CEO of Roche Diagnostics. “We look forward to helping them achieve a higher level of productivity, efficiency, and consistency across their eight facilities.”
In addition to the integration of new laboratory equipment, Roche Diagnostics and Florida Hospital are exploring future opportunities to collaborate on healthcare initiatives. “Florida Hospital and Central Florida continue to build Orlando as a medical destination,” says Keith Lowe, executive director of Florida Hospital Strategic Venture Group.