Diagnostic Testing & Technology Report
Diagnostic Testing & Technology Report contains up-to-the-minute information AND unique perspectives on where diagnostic testing is headed, covering every innovation, new product, manufacturer, market and end-user application. Each monthly issue provides an unbeatable blend of news, analysis, statistics, and forecasts. Keep up with the latest trends in esoteric lab testing and what the hottest new tests are worth to your bottom line. Plus, find out about the strategies that individual companies are implementing now to win the fight for specific local markets and which sector has the most potent resources and best game plan for the long term.
September 2006 - Table of Contents
Ventana Medical Systems (Tucson, AZ), a global supplier of automated diagnostic systems to the anatomical pathology market, has announced that it will acquire Vision Systems (Melbourne, Australia) for $346 million in cash. The merger agreement has been unanimously approved by the boards of both companies and is expected to close in the fourth quarter of this year.
Cancer research is all about profiling. Journals teem with new gene-expression, protein, and messenger RNA profiles that are associated with certain types of cancer and their outcomes. But testing and clinical management for many cancers still relies largely on anatomy: Where is the tumor? How big is it? Has it spread? As molecular oncology continues moving from bench to bedside, cancer diagnostics are becoming smaller, more accurate, faster, and less dependent on the trained eye of a pathologist.
Affymetrix (Santa Clara, CA) has announced its plan to launch a GeneChip containing one million single nucleotide polymorphisms (SNPs). The product, which will debut early next year, will sell for around $500. In the wake of the announcement, the company has reduced the price of its two-chip 500,000-SNP genotyping set to $250. Additionally, the 500K set will be available as a single array by the end of the year.
As it builds an impressive roster of clients for its infectious disease assay technology, analyte-specific reagent (ASR) developer and reference laboratory Prodesse (Waukesha, WI) has signed license agreements with Roche (Basel, Switzerland) and Invitrogen (Carlsbad, CA) to use the technologies of both companies to develop and validate molecular diagnostic assays.
The FDA has formed an internal FDA Nanotechnology Task Force, which is charged with determining regulatory approaches that encourage the development of safe and effective FDA-regulated products that use nanotechnology materials. The task force will recommend ways to identify and address gaps in knowledge or policy related to nanotechnology, particularly the potentially adverse health effects from these products.
Abbott (Abbott Park, IL) saw second-quarter sales growth of nearly 18% in its medical products division, led by growth in its vascular business but also boosted by double-digit sales growth in its molecular and point-of-care businesses. In the first half of 2006, Abbott’s diagnostic sales totaled $1.9 billion, up 4.4% on the previous year.
Even the most skilled of pathologists and the most powerful of microscopes cannot see the molecular changes that take place at the earliest stages of cancer. That’s why molecular diagnostics are increasingly seen as the standard of care when diagnosing many cancers, and why new predictive and diagnostic cancer tests are appearing in the scientific literature—and the clinical laboratory—every day.
At the City of Hope National Medical Center’s Clinical Molecular Diagnostic Laboratory (CMDL; Duarte, CA), it’s all about context. The CMDL is guided by what it calls the "Epidiomics Vision" of "molecular diagnosis in the context of molecular epidemiology and bioinformatics to guide the physician in the age of personalized predictive and preventive medicine." Fittingly, it is the laboratory’s strong ties to epidemiology, bioinformatics, and genetic research that have helped the eight-year-old CMDL to build a growing molecular test menu of impressive breadth, depth, and complexity.
Sysmex (Kobe, Japan) has received FDA clearance for its new XS-1000i automated hematology analyzer. The instrument has been cleared for use in clinical laboratories and physician offices. Additionally, the company’s XT-2000i and XT-1800i analyzers have just been cleared by the FDA for the analysis of cerebrospinal fluid, as well as serous and synovial fluids.
HemoCue (Angelholm, Sweden) has developed a single-analyte point-of-care testing system for determining total white blood cell count. Known as HemoCue WBC, the simple test can be performed in a doctor’s office, with results available in minutes. The company premiered the system at last month’s meeting of the American Association of Clinical Chemistry and now has its sights on a CLIA waiver.
Clinical diagnostics giant Dade Behring (Deerfield, IL) has launched tests for the illegal drug Ecstasy and for the immunosuppressant drug Tacrolimus. Both tests will be available on Dade’s Dimension family of chemistry analyzers as well as the company’s V-Twin and Viva-E drug testing analyzers. As of June 30, Dade had a total of 39,300 instruments installed worldwide.
In the wake of a 67% ($9.5 million) decline in second-quarter revenue for its genomics division, Gene Logic (Gaithersburg, MD) has announced that it will restructure the division, cutting about 80 jobs effective October 5 for an estimated savings of $8 million in salary and benefit costs. The cuts are the result of a larger, ongoing strategic review of the business that the company plans to complete this month.
So far, it’s been a good year for Chembio (Medford, NY): The diagnostics company received approval letters from the FDA for pre-market applications (PMAs) for its two rapid HIV test products, Sure Check HIV 1/2 and HIV 1/2 Stat-Pak; introduced Dual Path, a new platform that it will use to create new rapid tests; and saw revenues for the first half of the year rise by 75% compared to the same period in 2005. Next on the company’s to-do list: obtain CLIA waivers for the rapid HIV tests and release PrimaTB Stat-Pak, a rapid test for tuberculosis.
The 21 stocks in the G-2 Diagnostic Stock Index held steady in the four weeks ended August 4, with 10 stocks up in price, 10 down, and one unchanged. Year to date, the G-2 index is up 13%, while the S&P 500 is up 2% and the Nasdaq is down 5%.
Don’t miss the 24th Annual Lab Institute: Making Connections Work, September 27-30, 2006, at the Crystal Gateway Marriott, Arlington, Virginia. This year’s Institute features some of the lab industry’s most influential business and government leaders, including:
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