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 2008 - Table of Contents
The United States Food and Drug Administration (FDA) has cleared the Pathwork Tissue of Origin test for use in determining the origin of certain tumors, Pathwork Diagnostics (Sunnyvale, Calif.) announced on July 31. The molecular diagnostics company will sell the test to clinical laboratories as an in vitro diagnostic (IVD) kit, as well as continue to offer it as a service through Pathwork’s CLIA-certified laboratory.
In a recent survey, Washington G-2 Reports found that nearly two-thirds (65 percent) of 117 U.S. laboratories surveyed currently offer molecular diagnostic tests. While the current molecular offerings of these labs are dominated by infectious disease testing, labs are increasingly looking to add more advanced genetic testing to their assay menus.
On July 24, molecular diagnostics company AutoGenomics (Carlsbad, Calif.) filed papers with the Securities and Exchange Commission (SEC) for an initial public offering worth up to $86.3 million. The company, which intends to reincorporate in Delaware after the IPO, plans to list its shares on the Nasdaq under the symbol AGMX.
After a four-year lobbying campaign, America’s clinical laboratory industry is sleeping a little easier now that the Medicare competitive bidding demonstration project for clinical lab services, slated to launch on July 1 in San Diego, has been repealed. The repeal went into effect on July 15, after Congress overrode the president’s veto of the Medicare Improvements for Patients and Providers Act of 2008. The move by Congress also enacted major program changes advocated by clinical laboratory and pathology organizations, including a physician fee fix.
One-third of men in the United States over 75 are receiving prostate-specific antigen (PSA) testing, but the U.S. Preventive Services Task Force warns that such testing could do more harm than good. According to a recommendation and analysis published in the August 5 issue of the Annals of Internal Medicine, men age 75 and older should not be screened for prostate cancer, and younger men should discuss the benefits and harms of the PSA test with their clinicians before being tested.
Inverness Medical Innovations (Waltham, Mass.), the rapid diagnostics company that has moved aggressively into the health management market through acquisitions, premiered its newest HIV test at the International AIDS conference (AIDS 2008), held in August in Mexico City and attended by approximately 25,000 people. Meanwhile, the company plans to launch a more advanced, multi-array HIV test late this year.
Washington G-2 Reports estimates that approximately 65 million molecular diagnostics tests will be performed in 2008, and an increasingly diverse array of clinical laboratories—community hospitals and independent labs as well as the academic medical centers that pioneered the clinical use of molecular testing—are focusing on adding or expanding their offerings in this rapidly growing area, which continues to be dominated by testing for infectious diseases.
Molecular diagnostics company HandyLab (Ann Arbor, Mich.) has raised $19.2 million in a Series D funding round co-led by Dow Ventures and Lurie Investments. Other backers included EDF Ventures, Ardesta, Arboretum Ventures, and Pfizer Strategic Investments. The company has raised a total of approximately $44 million to date.
The U.S. Food and Drug Administration has granted Invitrogen (Carlsbad, Calif.) premarket approval (PMA) for a novel genetic test that can determine whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). The SPOT-Light HER2 CISH kit uses chromogenic in situ hybridization (CISH) to quantify HER2 gene expression in tumor tissue. The approved test kit, Invitrogen’s first to receive PMA, will be available in mid-August.
Microarray measurements of gene expression can help to predict the survival of lung cancer patients. This finding could lead to a test that would allow physicians to determine which lung cancer patients need the most aggressive treatment. The study, the largest of its kind, appears online and in the August issue of Nature Medicine.
Molecular diagnostics company Gene Express (Wilmington, N.C.) announced on August 11 that it will use the clinical trials service division of NeoGenomics (Ft. Myers, Fla.) to validate its lung cancer risk prediction and BCR/ABL tests, commercialize its tests, and validate future Gene Express technology to meet requirements of the U.S. Food and Drug Administration (FDA). Additionally, a licensing agreement allows NeoGenomics to use Gene Express’s standardized reverse transcription polymerase chain reaction (StaRT-PCR) platform technology for its own commercial activities.
Researchers from the University of Utah School of Medicine and University of California have developed an assay that facilitates diagnosis of chronic-illness related anemia and diseases of iron overload. The results of a study detailing the new tool are published in the August 2008 issue of the journal Cell Metabolism.
On July 24, microRNA (miRNA)-focused Rosetta Genomics (Rehovot, Israel, and Jersey City, N.J.) completed its acquisition of Parkway Clinical Laboratories (Bensalem, Penn.) for $2.9 million in cash and stock, with an additional payment to be triggered by the achievement of certain milestones.
High levels of alkaline phosphatase—a routinely measured laboratory marker of bone disease—may signal an increased risk of death in patients with chronic kidney disease (CKD), reports a study in the November Journal of the American Society of Nephrology (JASN). The study was published online on July 30.
A study published early online by the American Journal of Medical Genetics Part B: Neuropsychiatric Genetics shows that variations in the serotonin transporter gene could explain why some people with depression respond better than others to treatment with Celexa (citalopram), an antidepressant. The Mayo Clinic study of 1,914 subjects shows that two variations in the serotonin transporter gene (SLC6A4) have a direct bearing on how individuals might respond to citalopram.
A new bill, H.R. 6761, makes a controversial call to modernize the 24-year-old Medicare lab fee schedule. The bill was introduced July 31 by Reps. Bart Stupak (D-Mich.) and Michael Burgess (R-Texas) through the efforts of the Clinical Laboratory Management Association (CLMA) and the American Society for Clinical Laboratory Science (ASCLS). Stupak and Burgess are members of the Energy and Commerce Committee. CLMA and ASCLS are urging their members to get their representatives to sign on as cosponsors.
Biomarker-based tests could be used to diagnose Alzheimer’s disease (AD) in its earliest stages, according to a number of studies presented at the 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD2008), held in Chicago in July. Detecting AD-associated proteins and enzymes in cerebrospinal fluid (CSF) could identify affected individuals while they are still cognitively normal so that future AD therapies can preserve normal function.
The Riverside Company (Cleveland and New York City), a global private equity firm focused on the smaller end of the middle market (companies valued up to $200 million), has acquired GTI Diagnostics (Waukesha, Wis.), which develops, manufactures, and markets in vitro diagnostic assays for the transplantation (HLA), blood bank, and coagulation laboratory markets. GTI’s more than 20 test kits are used by approximately 400 labs around the world. Financial terms of the deal were not disclosed.
The August 8 stock market rally fueled by a $4.82-a-barrel drop in oil prices helped the G-2 Diagnostic Stock Index to rise an average of 14 percent in the five weeks ended August 8, with 14 stocks up in price and three down. The G-2 index is down 6 percent so far this year, while the S&P is down 11 percent and the Nasdaq has fallen 8 percent.
Lab Institute 2008 to Tackle Changing of the Guard . . . Join Washington G-2 Reports for its 26th annual Lab Institute, September 17-19 at the Crystal Gateway Marriott in Arlington, Virginia. This year’s program, "Changing of the Guard: Working With a New Administration, the New Millennial Generation, and a New Health Care System," examines fundamental realignments in politics, Medicare and health care reform policy, personalized medicine, and the molecular diagnostics market. At this year’s Lab Institute, you will:
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