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.
June 2008 - Table of Contents
Myriad Genetics (Salt Lake City) announced on May 6 that it will expand its direct-to-consumer (DTC) marketing campaign for BRACAnalysis, its flagship genetic test for hereditary breast and ovarian cancer. The first campaign debuted last September in the northeastern United States at an estimated cost to Myriad of $8 million and concluded in March of 2008. A second campaign of approximately the same size and cost will be held in the southern region of the country, primarily Texas and Florida, which Myriad says represents 18 percent of the U.S. market for BRACAnalysis, compared with 12 percent for the northeast region.
In its final report on gaps in the oversight of genetic testing, the Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) has urged the Centers for Medicare & Medicaid Services (CMS) to increase proficiency testing in this rapidly expanding market. The panel also said, in the report released April 30, that the Food & Drug Administration should expand its regulation to all lab tests, including lab-developed tests (LDTs).
Less than a year after approving a change in the labeling of warfarin to provide information about how people with certain genetic variations may respond to the popular blood thinner, the United States Food and Drug Administration (FDA) has cleared for marketing a third genotyping test to detect the presence of variations in the CYP2C9 and VKORC1 genes. Information about CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients at greater risk for warfarin sensitivity. The FDA previously cleared similar tests manufactured by Nanosphere (Northbrook, Ill.) and AutoGenomics (Carlsbad, Calif.).
Genzyme Genetics, the national laboratory owned by Genzyme (Cambridge, Mass.), has launched population carrier and prenatal diagnostic testing for spinal muscular atrophy (SMA), the most common inherited cause of infant mortality.
The Senate and the House of Representatives have passed the Genetic Information Non-Discrimination Act (GINA) bill, which bars employers from using genetic information in decisions on hiring, firing, job placement, or promotion. It also prohibits group health plans and other health insurers in the group and individual market from using genetic information to deny coverage or set premium rates and from requiring individuals to undergo genetic testing.
Inverness Medical Innovations (Waltham, Mass.) has completed its acquisition of health management company Matria Healthcare (Marietta, Ga.), the company announced on May 9. The final purchase price consisted of approximately $143.9 million and approximately 1.8 million shares of Inverness stock.
Charged in March of 2007 with investigating specific questions related to the adequacy and transparency of the current oversight system for genetic testing, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) submitted on April 30 its final report to Michael O. Leavitt, secretary of the Department of Health and Human Services (HHS). Among the committee’s key recommendations are calls for expanded federal oversight of laboratory tests in general, with genetic tests given highest priority and for increased proficiency testing (PT) in this rapidly expanding field.
LabCorp (Burlington, N.C.) and Siemens Healthcare (Deerfield, Ill.) have entered into a nonexclusive agreement to pursue co-development of diagnostics tests relating to companion diagnostics, metabolic syndrome, oncology, and diabetes, both companies announced on May 8. Developing companion diagnostics is increasingly a strategic focus for LabCorp, according to company officials.
Medicare Part B spending for clinical laboratory services increased to $6.8 billion in 2007, up 1.6 percent from 2006, according to the latest data from the 2008 Medicare Trustees Report. The increase, however, is less than in 2006, when the spending rose 3.7 percent over the total for 2005. Medicare Part B lab spending for 2008 is estimated to grow 3.1 percent to just under $7 billion.
According to a study in the May 7 issue of the Journal of the American Medical Association, the incidence of group B streptococcus (GBS) increased nearly 50 percent among adults between 1999 and 2005. Despite the increase in people aged 15 to 64 years, GBS was found to have declined approximately 25 percent among infants younger than seven days in the same period. Revised in 2002, the Centers for Disease Control and Prevention (CDC) guidelines recommend the screening of all pregnant women for GBS at 35-37 weeks of pregnancy.
Beckman Coulter (Orange County, Calif.) has licensed testing rights for the hepatitis C virus (HCV) from Siemens Healthcare Diagnostics (Deerfield, Ill.) for $12 million. Under the agreement, Beckman Coulter can develop, manufacture, and sell a quantitative viral load HCV blood test for use on the company’s molecular diagnostic instrument, which is slated to launch in 2010.
A team led by University of Texas researchers has developed a nano-bio-chip-based assay that could enable rapid, early diagnosis of heart attack, using saliva. Presented at the 2008 annual meeting of the American Association for Dental Research in April, the assay could ultimately be used to analyze a patient’s saliva at the point of care, in such settings as an ambulance or a dentist’s office.
An international team of researchers has identified a chromosomal region that is the source of genetic events that give rise to neuroblastoma, an often fatal childhood cancer of the peripheral nervous system that usually appears as a solid tumor in the chest or abdomen. In a study published May 7 in the New England Journal of Medicine online, the investigators found that the presence of common DNA variations in the 6p22 region of chromosome 6 raises the risk that a child will develop a particularly aggressive form of neuroblastoma.
Life sciences and biotechnology company Enzo Biochem (Farmingdale, N.Y.) has paid $18 million in cash and stock to acquire privately held Biomol International (Plymouth Meeting, Pa., and Exeter, England). With annual revenues of approximately $12 million and 50 employees in its United States and United Kingdom facilities, Biomol produces specialty life science products in the areas of signal transduction, lipid research, apoptosis, neuroscience, and drug discovery, with a research focus in functional proteomics.
The 18 stocks in the G-2 Diagnostic Stock Index fell an average of 4 percent in the five weeks ended May 2, with 11 stocks down in price, six up, and one unchanged. The G-2 index is down 13 percent so far this year, while the S&P 500 has fallen 2 percent and the Nasdaq is down 5 percent.
Laboratory Outreach Testing by the Numbers . . . Learn from industry leaders at Washington G-2 Reports’s seventh annual laboratory outreach conference, which will take place June 18-20 at the Bellagio Hotel in Las Vegas. The premier business event dedicated to improving the performance, profitability, and management of hospital and health system laboratory outreach programs will provide expert advice and practical strategies on such topics as outreach billing and collections, developing outreach sales and marketing plans, building strategic alliances, and using outreach as a strategy for hospital and health system growth, including the following confirmed speakers and sessions:
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