The ObservatoryApril
2003 NewsFDA requires barcodes on drugs and blood products. All blood and other biological products, as well as medications, will be required to be barcoded if a rule proposed by the Food and Drug Administration recently attains the expected final adoption. The proposed rule and other material related to the announcement can be found on the FDAs website athttp://www.fda.gov/oc/initiatives/barcode-sadr/New Down syndrome screening protocol encouraged. British researchers are urging that prenatal screening for Down syndrome be based on maternal age and four markers in the mothers blood. In a study published in the March 6 issue of the British medical journal Lancet, Dr. Nicholas Wald and colleagues from St. Bartholomews and The London School of Medicine and Dentistry assessed prenatal serum screening for Down syndrome with the quadruple test among 46,193 pregnancies in 14 hospitals over a five-year period. The quadruple test calculates the risk of a Down syndrome term pregnancy based on the maternal age and concentration of four markers in maternal serum alpha-fetoprotein, unconjugated estriol, human chorionic gonadotropin and inhibin-A at weeks 14 to 22 of the pregnancy. In the study, the quadruple screen detected Down syndrome in 81 percent of 88 pregnancies. The authors concluded that the quadruple test is a better method of screening for Down syndrome than the use of maternal age alone (51 percent detection rate) and is more effective than other second trimester screening tests, and urged that the quadruple test be the test of choice in second trimester Down screening.Rapid pre-screening of Pap smears effective as quality control. Quick partial preview scanning of Pap smears can improve the quality of cytology programs, according to a report in the Feb. 25 issue of the journal Cancer. Dr. Marc Arbyn of the Scientific Institute of Public Health in Brussels and his colleagues conducted a meta-analysis of pooled data on the diagnostic yielding of rapid prescreening of unreported smears. For all abnormalities, they found a 64.9 percent average sensitivity of rapid prescreening; for low-grade or more severe lesions, the average sensitivity was 72.6 percent; and for high-grade or more severe lesions, the sensitivity was 85.7 percent. Because they had previously found that rapid reviewing is better than fully reviewing a 10 percent sample of negative slides, researchers say the yield of a rapid pre-screening protocol is also likely to be superior.Medicare raises fees for pathology services effective March 1. Medicare reimbursements for pathology and other physician services rose an average of 1.6 percent effective March 1 to comply with a revised 2003 Physician Fee Schedule published by the Centers for Medicare and Medicaid Services. According to Washington G-2 Reports Lab & Diagnostic Alert, the revised 2003 conversion factor used to set physician fees is $36.7856 per relative value unit (RVU), compared to $34.592 as originally scheduled. The 2002 conversion factor was $36.1992. Some pathology RVUs were adjusted for 2003, resulting in more significant fee increases; among those services were comprehensive pathology consultations, referred records/slides, Pap smears with physician interpretation and flow cytometry, each cell marker. For more information, call Washington G-2 Reports at 1-800-522-7347.Executive War College May 6-7 in New Orleans. Two market forces patient safety and quality/productivity are changing how the nations clinical laboratories are organized and managed. Both trends will be front and center at this years Executive War College on Lab and Pathology Management, slated for May 6-7, 2003, in New Orleans. Leaders of the nations most innovative laboratories will share the full details about their successes and setbacks. Forty presentations will cover the full range of lab management issues, from med tech recruiting to automation to added-value lab-testing services. For information and to register, call 800-560-6363 or visit www.darkreport.com.Lab
TestspPSA improves prostate cancer detection. Proenzyme prostate specific antigen (pPSA) does a better job of detecting prostate cancer and helping prevent unnecessary biopsies than free PSA (fPSA) does, according to the results of a preliminary study reported in the February issue of Urology. Lori J. Sokoll, PhD, and colleagues at Johns Hopkins Medical Institution in Baltimore, report that in the 2.5 ng/mL to 4.0 ng/mL total PSA range, potentially 75 percent of cancers can be detected, with 59 percent of unnecessary biopsies being spared, using percentage of pPSA, as compared to only 33 percent of biopsies being spared using percentage of fPSA.New colon cancer blood test approved. Targeted Diagnostics & Therapeutics Inc. (TDT) announced recently that it has received regulatory approval to begin offering its new blood test, called GCC-B1, for the detection of recurrent colon cancer. TDT has been certified under the Federal Clinical Laboratories Improvement Amendment of 1988 (CLIA 88) for high-complexity laboratory testing. TDT says its new test represents a major breakthrough because its detection mechanism finds metastatic colorectal cancer that is often missed by other methods. The company says that GCC-B1 can find one cancer cell in 10,000,000 normal cells by detecting the presence of guanylyl cyclase C (GC-C), which is found on metastatic colorectal cancer cells. Detection of the presence of this marker in the blood is indicative of recurrent metastatic colon cancer. In ongoing clinical testing, the GCC-B1 test has been shown to have as high as 100 percent sensitivity and 91 percent specificity, according to TDT.© 2003 Nelson Publishing, Inc. All rights reserved.
2003 NewsFDA requires barcodes on drugs and blood products. All blood and other biological products, as well as medications, will be required to be barcoded if a rule proposed by the Food and Drug Administration recently attains the expected final adoption. The proposed rule and other material related to the announcement can be found on the FDAs website athttp://www.fda.gov/oc/initiatives/barcode-sadr/New Down syndrome screening protocol encouraged. British researchers are urging that prenatal screening for Down syndrome be based on maternal age and four markers in the mothers blood. In a study published in the March 6 issue of the British medical journal Lancet, Dr. Nicholas Wald and colleagues from St. Bartholomews and The London School of Medicine and Dentistry assessed prenatal serum screening for Down syndrome with the quadruple test among 46,193 pregnancies in 14 hospitals over a five-year period. The quadruple test calculates the risk of a Down syndrome term pregnancy based on the maternal age and concentration of four markers in maternal serum alpha-fetoprotein, unconjugated estriol, human chorionic gonadotropin and inhibin-A at weeks 14 to 22 of the pregnancy. In the study, the quadruple screen detected Down syndrome in 81 percent of 88 pregnancies. The authors concluded that the quadruple test is a better method of screening for Down syndrome than the use of maternal age alone (51 percent detection rate) and is more effective than other second trimester screening tests, and urged that the quadruple test be the test of choice in second trimester Down screening.Rapid pre-screening of Pap smears effective as quality control. Quick partial preview scanning of Pap smears can improve the quality of cytology programs, according to a report in the Feb. 25 issue of the journal Cancer. Dr. Marc Arbyn of the Scientific Institute of Public Health in Brussels and his colleagues conducted a meta-analysis of pooled data on the diagnostic yielding of rapid prescreening of unreported smears. For all abnormalities, they found a 64.9 percent average sensitivity of rapid prescreening; for low-grade or more severe lesions, the average sensitivity was 72.6 percent; and for high-grade or more severe lesions, the sensitivity was 85.7 percent. Because they had previously found that rapid reviewing is better than fully reviewing a 10 percent sample of negative slides, researchers say the yield of a rapid pre-screening protocol is also likely to be superior.Medicare raises fees for pathology services effective March 1. Medicare reimbursements for pathology and other physician services rose an average of 1.6 percent effective March 1 to comply with a revised 2003 Physician Fee Schedule published by the Centers for Medicare and Medicaid Services. According to Washington G-2 Reports Lab & Diagnostic Alert, the revised 2003 conversion factor used to set physician fees is $36.7856 per relative value unit (RVU), compared to $34.592 as originally scheduled. The 2002 conversion factor was $36.1992. Some pathology RVUs were adjusted for 2003, resulting in more significant fee increases; among those services were comprehensive pathology consultations, referred records/slides, Pap smears with physician interpretation and flow cytometry, each cell marker. For more information, call Washington G-2 Reports at 1-800-522-7347.Executive War College May 6-7 in New Orleans. Two market forces patient safety and quality/productivity are changing how the nations clinical laboratories are organized and managed. Both trends will be front and center at this years Executive War College on Lab and Pathology Management, slated for May 6-7, 2003, in New Orleans. Leaders of the nations most innovative laboratories will share the full details about their successes and setbacks. Forty presentations will cover the full range of lab management issues, from med tech recruiting to automation to added-value lab-testing services. For information and to register, call 800-560-6363 or visit www.darkreport.com.Lab
TestspPSA improves prostate cancer detection. Proenzyme prostate specific antigen (pPSA) does a better job of detecting prostate cancer and helping prevent unnecessary biopsies than free PSA (fPSA) does, according to the results of a preliminary study reported in the February issue of Urology. Lori J. Sokoll, PhD, and colleagues at Johns Hopkins Medical Institution in Baltimore, report that in the 2.5 ng/mL to 4.0 ng/mL total PSA range, potentially 75 percent of cancers can be detected, with 59 percent of unnecessary biopsies being spared, using percentage of pPSA, as compared to only 33 percent of biopsies being spared using percentage of fPSA.New colon cancer blood test approved. Targeted Diagnostics & Therapeutics Inc. (TDT) announced recently that it has received regulatory approval to begin offering its new blood test, called GCC-B1, for the detection of recurrent colon cancer. TDT has been certified under the Federal Clinical Laboratories Improvement Amendment of 1988 (CLIA 88) for high-complexity laboratory testing. TDT says its new test represents a major breakthrough because its detection mechanism finds metastatic colorectal cancer that is often missed by other methods. The company says that GCC-B1 can find one cancer cell in 10,000,000 normal cells by detecting the presence of guanylyl cyclase C (GC-C), which is found on metastatic colorectal cancer cells. Detection of the presence of this marker in the blood is indicative of recurrent metastatic colon cancer. In ongoing clinical testing, the GCC-B1 test has been shown to have as high as 100 percent sensitivity and 91 percent specificity, according to TDT.© 2003 Nelson Publishing, Inc. All rights reserved.
