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GLG News by Pricing Experts on Clinical Lab Testing in the U.S.

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Ken PowellNovember 19, 2008
New Cervista(tm) HPV Clincial Trials Reoprt Success
Analysis of: Cervista(TM) HPV Clinical Trial Met Or Exceeded All Of The Target End Points | www.devicespace.com
Author: Ken Powell, President, Genesis Business Development
Hologic's (NASDAQ: HOLX) recently reported successful Cervista(tm) high-risk, Human Papilloma Virus (HPV) clinical trial results at this week's Eurogin Conference on Cervical Cancer.  This is evidence that more companies are poised to enter the $1 billion dollar market...
Ken PowellNovember 18, 2008
Heart Failure Diagnostic Test
Analysis of: New test to identify heart failure in ER superior | www.reuters.com
Author: Ken Powell, President, Genesis Business Development
A novel biomarker developed by Brahms AG could transform the treatment of heart failure patients presenting to the Emergency Department (ED).  This new clinical diagnostic test could pose a challenge to the current marketers of B-type natriuretic peptide (BNP) and N-terminal pro-BNP (NT-proBNP),...
Ken PowellNovember 18, 2008
Breast Cancer Gene Study Findings
Analysis of: Family history can trump breast cancer gene test | hosted.ap.org
Author: Ken Powell, President, Genesis Business Development
A new University of Toronto study shows that women from breast cancer-prone families who test negative for the BRAC1/BRAC2 genes had a fourfold higher risk of developing breast cancer than average women after 5 years.  Dr. Steven Narod, the study author, said that family history is a stronger...
Ken PowellNovember 17, 2008
Infection Control Opportunities
Analysis of: Medicare restrictions on payments for hospital-acquired conditions could provide opportunities for device and diagnostic manufacturers. | www.devicelink.com
Author: Ken Powell, President, Genesis Business Development
Evolving Center for Medicare and Medicaid Services (CMS) reimbursement restrictions could present medical diagnostic and device manufacturers with new opportunities to reduce the cost and frequency of hospital acquired infections.  April 30, 2009 is the target date for the new list of nonreimburseable...
Ken PowellNovember 10, 2008
Molecular Markers for Prostate Cancer
Analysis of: Health Discovery Corporation: Four Genes Comprising the New Molecular Diagnostic Signature for Prostate Cancer Successfully Identified in Urine | www.marketwatch.com
Author: Ken Powell, President, Genesis Business Development
New molecular markers for prostate cancer identified by Health Discovery Corporation (OTC BB: HDVY.OB) could prove to me more specific and sensitive than conventional serum assays for prostrate cancer.  In addition, since this urine-based test is non-invasive, it could increase compliance...
Ken PowellNovember 6, 2008
FDA Regulation of Molecular diagnostics
Analysis of: Sales of Test for Ovarian Cancer Halted | www.nytimes.com
Author: Ken Powell, President, Genesis Business Development
The FDA's recent warning letter to Labcorp regarding the sale of OvaSure, a molecular diagnostic test for ovarian cancer, demonstrates the FDA's intent to step up their oversight of molecular diagnostic tests.  Diagnostic companies involved in developing novel molecular diagnostic tests...
Ken PowellNovember 6, 2008
New MRSA Test
Analysis of: ReaX™ PCR Assays For Effortless Detection of Hospital Acquired Infections | www.medcompare.com
Author: Ken Powell, President, Genesis Business Development
The high cost of Hospital Acquired Infections (HAIs) is drawing new competitors into this fast growing In Vitro Diagnostics (IVD) market segment.  New entrants such as Q Chip Ltd and others will accelerate market awareness of HAIs, solutions and enable global market...
Ken PowellNovember 6, 2008
HIV Point-of-Care Screening Shows Benefits
Analysis of: Rapid HIV Testing in the ER Boosts Diagnoses, Screening | www.medcompare.com
Author: Ken Powell, President, Genesis Business Development
A recent study by researchers at Henry Ford Hospital in Michigan showed that screening of patients in the Emergency Department (ED) found that 1 on 50 patients tested for sexually transmitted diseases were infected with HIV.  Screening programs such as these and CDC recommendations to screen...
September 25, 2008
Narrowing the Category of "Carcinoma of Unknown Primary" Site-- still a ways to go
Analysis of: Raising the Profile of Cancer of Unknown Primary | jco.ascopubs.org
Author: GLG Expert Contributor
Diagnostic uncertainty in metastatic cancer as to the site of origin remains a problem in medicine today, albeit a slowly shrinking one. Immunohistochemistry using monoclonal antibodies from a host of makers will remain the mainstay in defining the site of origin, but it's proper use depends on accurate...
Ken PowellJuly 28, 2008
New blood-based test for colorectal cancer
Analysis of: GeneNews begins marketing ColonSentry colorectal cancer screening test | www.labnews.com
Author: Ken Powell, President, Genesis Business Development
A non-invasive, DNA-based screening test for colon cancer could significantly increase the 90MM US adults over 50 that should participate in colorectal cancer screening.  Colon cancer is responsible for approximately 57,000 deaths in the US each year and account for 9% of all cancer deaths. ...

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