SAN DIEGO — This year's Clinical Lab Expo portion of the American Association for Clinical Chemistry (AACC; Washington) annual meeting, concluded last week, was the largest in the organization's history, with nearly 700 exhibitors in more than 1,800 booths.
Early in the week Abbott Laboratories (Abbott Park, Illinois) reported that more than 40 assays and reagents targeted for launch by the company in 2007 and 2008, although many are being marketed outside the U.S.
Among the new assays designed for Abbott's Architect or AxSym platforms is the intact parathyroid hormone assay for kidney disease for the global market and designed for the Architect system; also, an assay for tacrolimus, an immuno-suppressant drug used by transplant patients that must be closely monitored.
Released to the global market is an assay for Active B-12 on its AxSYM platform to detect vitamin B12 deficiency, which Abbott said is a growing problem among the elderly and those using medications such as H(2) antagonist and proton pump inhibitors. The company said that such a deficiency has been correlated with the risk of heart disease, stroke and cognitive decline.
Prior to AACC, Abbott reported that it had received approval from the FDA for its Prism HCV test for hepatitis C, a blood screening test to screen individual donations of blood and plasma for antibodies to hepatitis C.
"With the Abbott Prism system, we continue to support the infectious disease testing needs of the laboratory while helping realize greater efficiencies and enhanced operator safety throughout the blood and plasma screening process," said William Brown III, PhD, VP, diagnostic assays and systems development for Abbott.
Abbott says that in 1985, it developed the first HIV blood-screening test approved in the U.S.
According to the American Association of Blood Banks, 8 million volunteers donate about 15 million units of whole blood each year. Each donated unit of blood is tested for infectious diseases including hepatitis, HIV and other retroviruses.
Roche Diagnostics (Indianapolis) sponsored an appearance by Christopher Kennedy Lawford, a nephew of President John F. Kennedy, who shared with attendees his story of diagnosis and successful treatment of hepatitis C, a silent viral liver infection.
Roche reported that one-third of its molecular customer base has already purchased or ordered its COBAS AmpliPrep/COBAS TaqMan HIV-1 Assay, just eight weeks after the assay received approval from the FDA.
"This is the most successful launch of a new molecular test at Roche Diagnostics," said Susan Zienowicz, VP of molecular diagnostics at Roche. "Not only have we experienced unprecedented market acceptance off the new HIV-1 assay, but we were able to quickly get the assay into the hands of our customers ..."
On the new products front at Roche, one of the devices it was demonstrating at the AACC meeting was its RALS-Plus, a multi-vendor point-of-care data management program from Medical Automation Systems currently being used for POC testing data management in more than 1,200 hospitals across the U.S.
Roche said the program is designed to help clinicians with a "variety of POC testing program needs," including operator management and certification, results management and evaluation, quality control management and program reporting.
"The addition of blood gas device connectivity through RALS-Plus offers several benefits to hospitals that already use the program for data management with Accu-Chek blood glucose monitors," said Larry Healy, associate marketing manager at Roche.
These benefits include being able to manage data from multiple testing platforms in a single program, the company said.
Nanogen (San Diego) reported that it had begun shipment of its congestive heart failure product, the StatusFirst CHF NT-proBNP rapid test. The product is CE-marked and has been cleared by the FDA for diagnostic use with EDTA plasma samples.
"With an aging population and more people surviving myocardial infarctions, the market for cardiac diagnostics related to heart failure is expected to exceed $500 million annually in the next five years," said David Ludvigson, Nanogen president/CEO.
The StatusFirst CHF test measures circulating levels of NT-proBNP, a biomarker for heart disease, and provides a quantitative assess of the biomarker's concentration in as little as 15 minutes via a "small, low-cost reader," Nanogen said.
Nanogen was founded in 1993 by Howard Birndorf, characterized by Suzanne Clancy, PhD, senior manager of corporate communications for the company, as the "father of biotech."
And while how to keep IVD devices and reagents dry is not always top-of-mind, it can be an essential part of the accuracy of a test, depending on its chemistry, said Robert Sabdo, head of diagnostic and specialty packaging with MultiSorb Technologies (Buffalo, New York), a company founded in 1961 that today provides dessicants across many industries.
He told Diagnostics & Imaging Week that a company's packaging becomes more important if, for example, the product may not be used immediately but has a longer shelf-life.
Sabdo said the company counts some of the top names in IVDs among its customers.