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iNdustry p r o f i L e s p r o f i L e s Gen-probe offers $334 million molecular diagnostics market, which we estimate is growing at roughly double the bid for innogenetics rate of the U.S. market,” said Gen-Probe seeking a deal that could make it the CEO Hank Nordhoff. “The proposed ac- largest stand-alone molecular diagquisition would provide access to a number nostics company in the world, Gen-Probe of complementary products, technologies, launched a $334 million cash bid for the and markers that are generating revenue Ghent, Belgium-based diagnostics compa- today or that we believe could be commerny Innogenetics. The Gen-Probe offer is 6% higher than an initial April 25 bid by Solvay Pharmaceuticals S.A. (Brussels, Belgium). cialized in the future.” If Innogenetics accepts the Gen-Probe bid, siemens, labcorp planning the combined company would boast more than $500 million in sales for 2008, according to Gen-Probe. “We believe our pro- To co-develop Tests siemens Healthcare and LabCorp announced a preliminary agreement to posed acquisition of Innogenetics would co-develop new clinical diagnostic tests provide strategically valuable marketing for companion diagnostics, metabolic and sales, distribution, and manufacturing syndrome, oncology, and diabetes. “This capabilities to accelerate commercialization agreement establishes a framework that of Gen-Probe products in the European gives both companies an opportunity to offer new diagnostic tests to the laboratories, physicians, and their patients more quickly and effectively than either could do alone,” said David Hickey, senior vice president of strategic planning and business development for Siemens. “Advancing healthcare for patients is an important commitment that we can reach through strategic relationships such as this.” Financial terms were not disclosed. labcorp signs deal to offer companion Test for new schizophrenia drug announced a deal with Vanda l abCorp Pharmaceuticals to develop and sell diagnostic tests for pharmacogenetic markers that Vanda identified in the course of its development of the schizophrenia drug Fanapta (iloperidone), which is still under FDA review. “Working with innovative companies like Vanda to commercialize predictive medicine tests is a critical strategic focus for LabCorp,” said Andrew Conrad, PhD, chief scientist and global head of clinical trials for LabCorp. “This collaboration is an example of our commitment to the advancement of personalized medicine and represents a successful translation of a research-based assay into a valuable diagnostic test. This relationship is consistent with our focus on companion diagnostics.” Financial terms of the deal were not disclosed. nanogen Gets cdc contract for flu Test for the second time, the CDC has awarded Nanogen a contract to develop a rapid flu test as part of the CDC’s plan to prepare for a potential flu pandemic. The $10.4 million, 2-year contract will have Nanogen develop a fast molecular test that simultaneously detects and differenti- ates influenza A, B, seasonal flu (H1N1 and H3N2) strains, and RSV. The agreement also provides for a secondary test for avian flu strains (H5N1, H7N1,and H9N1) to be used for samples that are positive for flu A but negative for seasonal flu. Nanogen said the test will be significantly more sensitive than current rapid flu tests and will take half the time. “Recently there have been a number of multiplexed molecular products for respiratory targets to hit the market,” said Nanogen CEO Howard Birndorf. “These products, however, are expensive and test for more pathogens than are useful in clinical diagnosis. Having a fast molecular assay that can be used as a confirmatory test for influenza will improve the tools available to clinicians for better patient health management.” Nanogen will develop the test in partnership with the Medical College of Wisconsin and Handylab, Inc. chembio awarded nih Grant for rapid Tb Test chembio Diagnostics announced a $296,000 NIH Small Business Innovation Research (SBIR) grant to develop a simple, rapid, accurate, and cost-effective blood test for active tuberculosis that can be used in resource-limited settings. The test will use Chembio’s Dual Path Platform technology together with antigens from a large panel of novel recombinant antigens identified at the Infectious Disease Research Institute (IDRI, Seattle, Wash.), a research organization focused on technologies for the developing world. Under the terms of its NIH SBIR award, Chembio will share approximately 1/3 of the grant funds with IDRI. Chembio will develop the new test for POC or field use, with results produced within 15 minutes. The test will offer a visual reading, as well as an optional automated readout of the result. CliniCal laboratory news JuLy 2008 45
even mildly elevated Glucose poses risk in pregnancy large international study shows a con- a tinuum of risk to fetuses as mothers’ glucose levels rise (NEJM 2008; 358: 1991–2002). To settle a controversy about whether maternal hypoglycemia that falls short of diabetes is associated with adverse pregnancy outcomes, a multinational team of researchers tested glucose levels in 25,505 pregnant women at 24 to 32 weeks of gestation at 15 centers in 9 countries. Researchers blinded data for mothers with fasting plasma glucose levels ≤105 mg/dL and 2-hour plasma glucose levels ≤200 mg/dL. Primary outcomes were birth weight above the 90th percentile for gestational age, primary cesarean delivery, clinically diagnosed neonatal hypoglycemia, and cord-blood serum C-peptide level above the 90th percentile. Secondary outcomes were delivery before diagNostiC 46 CliniCal laboratory news JuLy 2008 p r o f i L e s p r o f i L e s 37 weeks of gestation, shoulder dystocia or birth injury, need for intensive neonatal care, hyperbilirubinemia, and preeclampsia. For the 23,316 participants with blinded data, the researchers calculated adjusted ORs for adverse pregnancy outcomes associated with an increase of 1 standard deviation in the fasting plasma glucose level (6.9 mg/dL), the 1-hour plasma glucose level (30.9 mg/dL), and the 2-hour plasma glucose level (23.5 mg/dL). For birth weight above the 90th percentile, those ORs (95% CI) were 1.38 (1.32–1.44), 1.46 (1.39–1.53), and 1.38 (1.32–1.44), respectively. For cordblood serum C-peptide level above the 90th percentile, the ORs were 1.55 (1.47–1.64), 1.46 (1.38–1.54), and 1.37 (1.30–1.44). ORs for primary cesarean delivery were 1.11 (1.06–1.15), 1.10 (1.06–1.15), and 1.08 (1.03–1.12). ORs for neonatal hypoglycemia were 1.08 (0.98–1.19), 1.13 (1.03– 1.26), and 1.10 (1.00–1.12). The researchers found no obvious thresholds for increased risk. Associations for secondary outcomes were significant, but weaker. longer cholesterol Testing intervals recommended physicians should consider a testing interval of 3 years or more for patients who have well-controlled cholesterol levels and adhere to cholesterol-lowering medications, authors of a recent paper suggest (Annals of Internal Medicine 2008; 148: 656– 661). Because research has not yet shown an optimal cholesterol monitoring interval and clinical practice varies, researchers from the U.K. and Australia sought to estimate both the variation in initial response to treatment and the long-term drift from initial response. They also aimed to estimate the ability to detect long-term changes in cholesterol levels during treatment (signal), given short-term, within-person variation (noise). The research team analyzed serum cholesterol concentrations at baseline, 6 months, and 12 months, and annually thereafter for the next 4 years in 9,014 patients who participated in the LIPID (Long-Term Intervention with Pravastatin in Ischemic Disease) trial. Researchers randomized the patients, who had past coronary heart disease, to receive pravastatin or placebo. Both the placebo and pravastatin groups showed small increases in within-person variability over time. The estimated within-person standard deviation increased from 15 mg/ dL (CV, 7%) to 23 mg/dL (CV, 11%), but it took almost 4 years for the long-term variation to exceed the short-term variation. This slow increase in variation and the modest increase in mean cholesterol level, about 2% per year, suggest that most of the variation in the study is due to short-term biological and analytic variability. The researchers maintained that for patients with levels ≥19 mg/dL under target, monitoring is likely to detect many more false-positive results than true-positive results for at least the first 3 years after treatment. from 136.2 to 133.5 mg/dL, and increased over the subsequent 2 days to 141.8 mg/dL. These changes did not seem to be clinically meaningful, according to the researchers. Similar changes were observed for total cholesterol and smaller changes for HDL-C, but fasting triglyceride levels did not change. pca3 score predicts prostate Tumor volume newly published study suggests that a the prostate cancer gene 3 (PCA3) test might have clinical application in selecting men with low-grade and low-volume tumors who would be suitable candidates for active surveillance (J Urol 2008 179:1804– 1809). To assess association of urinary PCA3 score with prostatectomy tumor volume and other clinical and pathological features, a research team from the University of Texas M.D. Anderson Cancer Center collected urine specimens after digital rectal examinations from 59 men scheduled for prostate biopsy and 83 men scheduled for radical prostatectomy. The researchers evaluated prostatectomy findings from 96 men, using the Gen-Probe DTS 400 System to quantify PCA3 and PSA mRNA, and tabulated PCA3 score as ratio of PCA3 mRNA to PSA mRNA X 100. Scores for the 30 men with negative biopsies and the 29 with positive biopsies differed significantly, with medians of 21.1 and 31.0, respectively. PCA3 scores were significantly correlated with total tumor volume in prostatectomy specimens and with prostatectomy Gleason score, but not with other clinical and pathological features. When researchers compared low volume/low grade cancer (dominant tumor volume less than 0.5 cc, Gleason score 6) and significant cancer, differences in PCA3 scores were significant. In multivariate analysis, PCA3 was the best predictor of total tumor volume in prostatectomy. ROC curve analysis showed that the PCA3 score could discriminate low volume cancer (total tumor volume less than 0.5 cc) well, with AUC of 0.757. minimal change in lipids after acs low vitamin d levels linked to mean lipid levels vary little in the 4 depression in the elderly days after an ACS event and can help large population-based study shows guide selection of lipid-lowering medica- a depression status and severity is assocition, according to the results a recent study ated with decreased serum 25-hydroxyvita- (J Am Coll Cardio. 2008; 51:1440–1445). To min D [25(OH)D] levels and increased se- help quell a debate over how long changes rum parathyroid hormone (PTH) levels in in lipid levels persist after ACS, researchers older adults (Arch Gen Psychiatry 2008;65: from University of Michigan, Ann Arbor, 508–512). A team of researchers from the analyzed data from the LUNAR (Limit- Netherlands determined if 1,282 commuing UNdertreatment of lipids in ACS with nity residents ages 65–95 suffered from de- Rosuvastatin) trial to assess lipid changes pression using self reports and diagnostic 1 to 4 days after ACS onset. The prospec- interviews. They assessed levels of 25(OH) tive, multicenter, randomized, open-label D and PTH and considered potentially study’s overall goal was to compare efficacy confounding factors such as age, sex, smok- of the two drugs in adults hospitalized for ing, body mass index, and explanatory fac- acute ST-segment elevation myocardial intors including the season of measurement farction (STEMI), non-STEMI, or unstable and physical activity. 25(OH)D levels were angina (UA). Before treatment, research- 14% lower in 169 persons with minor deers measured serum lipid levels in blood pression and 14% lower in 26 persons with samples at medians of 26 hours, 43 hours, major depressive disorder, compared with and 84 hours after onset of ACS symptoms. levels in 1,087 controls. Levels of PTH were Of the 507 patients available for analysis, 5% and 33% higher, respectively. Depres- 212 were admitted for STEMI, 176 for non- sion severity was significantly associated STEMI, and 119 for UA. The LDL-C levels with decreased serum 25(OH)D levels and decreased in the 24 hours after admission, increased serum PTH levels.
Page 1 and 2: news brief IVD Market Growth Looks
Page 3 and 4: Clinical Laboratory News ediTorial
Page 5 and 6: GINA Opens Door for Research Partic
Page 7 and 8: CLN’s Lab 2008: improviNg heaLthC
Page 9 and 10: abnormal lipoproteins. Using the NH
Page 11 and 12: among healthcare workers is whether
Page 13: Quality Gaps in Communicating Labor
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