Alaris Medical Systems (San Diego, California), developer of products for the safe delivery of intravenous (IV) medications, unveiled the company-sponsored IV Medication Harm Index during its third invited conference held in San Diego in early November. The meeting, "Addressing Harm with High-Risk Drug Administration," gathered a group of experts in medication safety to discuss IV medication errors which pose the greatest risk of patient harm. Almost all high-risk drugs are delivered intravenously, and 61% of the most serious and life-threatening potential adverse drug events are IV drug-related. The gathering of thought leaders was hosted by the Alaris Center for Medication Safety and Clinical Improvement.

Conference participants focused particular attention on the new IV Medication Harm Index, presented by Dr. Jacqueline Sullivan, director of translational research at the Hospital of the University of Pennsylvania (Philadelphia, Pennsylvania). Developed by an industry-wide, multidisciplinary workgroup sponsored by Alaris Medical, the IV Medication Harm Index is designed to help clinicians, researchers, and hospital administrators measure harm from averted IV medication errors, or "near misses," for the first time. Unlike the National Coordinating Council for Medication Error and Prevention (NCC MERP) tool, used to categorize errors that have actually occurred, the IV Medication Harm Index will be used to evaluate the averted harm.

It is now possible to identify and measure averted IV medication errors with the introduction of "smart pumps" equipped with IV medication error-prevention software that helps to reduce medication errors by alerting clinicians when a dosage calculation is wrong and intercepts serious human error in programming. Smart pumps incorporate continuous quality improvement (CQI) data to log all alerts, which allows a hospital to track programming errors, or near misses, that have been averted and could have resulted in patient harm. CQI data provide a new source of information to assist in identifying opportunities for process improvements. Because of this, smart pump technology is rapidly becoming the "gold standard" in IV medication safety.

Data analyzed by the IV Medication Harm Index include the type of drug involved, the number of times the limit the drug was over- or under-dosed, the patient care unit where the error was averted (e.g., ICU, NICU), and the likelihood of a particular error being detected by clinicians. The index will permit hospitals to compare their IV error rates with those of others and allow them to demonstrate improvements in safe IV medication delivery. "The IV Medication Harm Index provides us with an evidence-based tool to quantify clinical severity associated with potential IV medication errors," Sullivan said. "This tool has appropriate critical psychometric properties with the ability to be further refined as we learn more. For the first time we have a tool that can help correlate prevented IV medication errors with averted costs."

"With the development of the IV Medication Harm Index, [our] department of nursing, in partnership with Alaris, has developed a nursing-science based assessment that can help improve patient safety," said Victoria Rich, PhD, chief nursing officer at the Hospital of the University of Pennsylvania. "The key element of this partnership is to provide nurses at the bedside with safety technology based on research."

Nanoparticle tech broadens protein detection

Nanosphere (Northbrook, Illinois) has acquired what it is calling breakthrough nanoparticle detection technology for protein biomarkers that, when combined with the company's nanoparticle-based detection systems for DNA, will add a third capability to detect proteins in addition to DNA and RNA. The technology was acquired through a licensing agreement with Northwestern University (Evanston, Illinois), and the company expects the technology to enable it to "broadly impact the fields of molecular diagnostics, genomics and proteomics."

"Essentially, [this] is a very robust demonstration of protein detection with our same fundamental technology," Vijaya Vasista, Nanosphere's chief operating officer, told The BBI Newsletter. "We have always said that our technology is going to be one platform that can do all types of molecular detection: DNA, RNA and proteins. So, in that sense, what we have now is a very robust demonstration of the fact that it can indeed do proteins and to a sensitivity level that's unprecedented," she said.

Invented by Nanosphere co-founder Chad Mirkin, a professor at Northwestern University (Evanston, Illinois), the detection system exhibits "1 million times more sensitivity" than standard methods in the detection of prostate specific antigen, which is a protein linked to prostate cancer, the company said. The new technology is expected to enable the ultimate detection of markers for diseases such as HIV, Alzheimer's disease and many forms of cancer, it added. "As genomics moves to proteomics, and people become more and more interested in protein detection and the impact of early detection of certain proteins in terms of diagnosing cancer or other clinical value, the Nanosphere platform is going to be able to meet that need, as well," Vasista said.

Nanosphere's core technology utilizes DNA probes, which the company describes as "completed DNA sequences attached through a proprietary modification procedure to small gold particles known as nanoparticles" hence its name. Those nanoparticles have a diameter of about 13 nanometers. If a target sequence is present in a sample being tested, the DNA probe binds to the target and the subsequent "signal" from the DNA probe establishes the presence of the target. Therefore, probes can be designed to detect any number of DNA sequences.

Vasista said that the company's first molecular detection system, Verigene ID, was launched in June for research purposes only. However, Nanosphere has completed its first customer evaluations in hospitals, and she characterized them as going "extremely well." She added: "Now, what we're doing is establishing good manufacturing practice so that we can obtain clearance, such that we would be able to sell into molecular laboratories for diagnostic purposes; we're hopeful that will be by the end of next year."

Sequenom IDs breast cancer genes

Sequenom (San Diego, California) said it has identified genetic markers in four genes for susceptibility to breast cancer, with each gene having forms that increase or decrease the risk of developing breast tumors. The expectation is that these markers will be used to develop both diagnostics and therapeutics, if possible, Chief Executive Officer Toni Schuh, chief executive officer of Sequenom, told The BBI Newsletter. "The objective at this point clearly is to partner with companies and entities that have a position in the market, servicing and product companies to partner these out," Schuh said. "Of course, in the long run we also want to offer diagnostic genetic and predisposition panels on our own platform." Schuh said that the company is in "a number of" conversations, although he expects that it will be anywhere between three months and 12 months to negotiate a deal, given the time it takes to negotiate term sheets and draw up contracts.

Sequenom said its data indicate that common combinations of the breast cancer markers "increase the average risk of developing breast cancer by a factor of two, and are present in about 11% of the female population." In certain rare combinations, it said, the risk of breast cancer is increased by up to a factor of five. "The protective forms of the genes are present in approximately 13% of the female population and are associated with a five-fold decreased risk of developing breast cancer compared to the general population," the company said.

The marker panel was identified in Sequenom's discovery genetics program using unrelated patient and control subjects of European descent, although it said it has replicated the initial association of the markers in an independent Australian cohort.

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