College of American Pathologists
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CAP Today




October 2012

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For biospecimen management, NovoPath biobank software

NovoPath has introduced NovoBioBank for biospecimen banking. It operates as a standalone or an integrated system, interfacing with both laboratory and clinical research information systems.

The customizable software solution, based on user-designed specs, supports scalable collaboration between multiple sites. It’s a flexible module that enables collection of pertinent specimen data, extensive search parameters, and on-the-spot information, including order status, shipping, billing, and maintenance reports.

NovoBioBank supports the capture, standardization, and organization of relevant data, both patient/donor and biospecimen oriented, providing secure access to well-annotated biospecimens while maintaining confirmed chain of custody. Data are managed and tracked through all phases of the biospecimen life cycle, from informed consent and collection and processing to distribution fulfillment and disposal. Full-search capacity of operator-defined annotation and query criteria cover all data parameters, from patient/donor demographics to specimen molecular analysis and everything in between.

FDA clears GenMark’s RVP

GenMark Diagnostics has received FDA 510(k) clearance for its eSensor respiratory virus panel for use on its XT-8 system. The test is intended to simultaneously detect and differentiate 14 clinically relevant viruses from patients with influenza-like illness.

“The FDA review process, which was both collaborative and thorough, resulted in a 510(k) clearance which supports performance claims that we believe will meet customer needs and expectations, especially with regard to specificity, sensitivity, and limits of detection,” Hany Massarany, GenMark president and CEO, said in a statement.

Beckman to acquire Iris

Danaher Corp. and a wholly owned subsidiary of Beckman Coulter have entered into a definitive merger agreement with Iris International, pursuant to which Beckman will acquire Iris for an aggregate price of about $378 million.

Beckman Coulter is a wholly owned subsidiary of Danaher.

“Iris provides an excellent complement to Beckman Coulter’s core business, as we continue to focus on our strategy of serving the core hospital laboratory,” Tom Joyce, Beckman Coulter president and Danaher executive vice president, said in a statement. Iris has “excellent automated and semiautomated urinalysis products that our shared customers really like,” he said, noting that the acquisition also adds unique cell imaging technology, which may enhance Beckman’s hematology product lines.

Under terms of the deal, Danaher, through a wholly owned subsidiary of Beckman Coulter, will commence a cash tender offer to purchase all outstanding shares of Iris’ common stock for $19.50 per share. The transaction is expected to close in the fourth quarter of the year.

AdvanDx launches QuickFISH

AdvanDx on Sept. 24 launched its QuickFISH rapid pathogen identification test for bloodstream infections. The test was FDA (510)k cleared on April 3, and the company has completed CE-Mark requirements for it to be launched in the European Union.

QuickFISH, which has a 20-minute turnaround time, will help clinicians, hospital pharmacists, and clinical microbiologists provide better targeted antibiotic therapies for patients with bloodstream infections, including septicemia, caused by Staphylococcus aureus and coagulase-negative staphylococci.

The QuickFISH molecular diagnostic platform is based on the company’s peptide nucleic acid fluorescence in situ hybridization, or PNA FISH, technology and enables species identification of bacteria directly from positive blood cultures in 20 minutes, allowing pathogen ID to be reported at the same time as Gram stain results are reported.

Keith S. Kaye, MD, MPH, professor of medicine and corporate medical director, infection prevention, epidemiology, and antimicrobial stewardship, Detroit Medical Center and Wayne State University, said in a statement that the test will “improve antibiotic stewardship efforts and decrease inappropriate and unnecessary antibiotic utilization.”

Additional QuickFISH assays for identifying other clinically important microbial species are in development.

Roche introduces CMV viral load test

Roche Diagnostics’ Cobas AmpliPrep/Cobas TaqMan CMV test, which quantifies a patient’s viral load of cytomegalovirus, is now available. It received FDA premarket approval in July. It is intended for use as an aid in managing solid-organ transplant patients undergoing anti-CMV therapy.

The new test gives diagnostic laboratories a standardized, FDA-approved option for CMV viral load testing that addresses a “key medical need for transplant patients,” Whitney Green, senior vice president of molecular diagnostics, Roche Diagnostics, said in a statement.

The real-time PCR-based CMV test provides standardization of CMV viral load monitoring with traceability to the WHO International CMV standard and is for use on the Cobas AmpliPrep/Cobas TaqMan system.

FDA clears Meridian’s group A strep test

Meridian Bioscience has received FDA clearance for its Illumigene molecular diagnostic test for group A Streptococcus on the company’s Illumigene platform. Using loop-mediated isothermal DNA amplification technology, the test detects Streptococcus pyogenes in throat samples.

Donna Mayne, supervisor of the microbiology, serology, and molecular labs at Sacred Heart Hospital, Pensacola, Fla., said in a statement from Meridian: “The utilization of GAS molecular testing decreases our turnaround time and offers increased sensitivity.”