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Clinical Pathology Laboratories Ignore the Rapid Growth of Mobile Apps in Healthcare at Their Peril
Pathology groups and clinical laboratories have opportunity to use mHealth to add value to clinicians

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Clinical Laboratories in United States Show More Interest in ISO 15189 Accreditation
It may be a small number of 15189-accredited medical laboratories, but these are prominent lab organizations and their ranks are growing

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Growth of Medicare and Private Payer ACOs Shows Acceptance of New Care Model
Pathologists and clinical laboratory administrators have an opportunity to add value to physicians who are transitioning to new ACO model

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Massachusetts Blue Cross Blue Shield Initiates Pre-authorization for Painkillers to Control Drug Abuse
Pre-authorization for therapeutic drugs is one step on the path to payers requiring similar pre-authorization for expensive clinical laboratory tests

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High School Student Develops Diagnostic Test to Detect Early-Stage Pancreatic Cancer
New approach to clinical laboratory testing could eliminate the need for tissue biopsies to diagnose different types of cancer

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FDA Clears New Rapid Clinical Laboratory Test for Market that Reduces Time-to-Answer for Bloodstream Infections to Two Hours
Nanosphere’s Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) gives pathologists and clinical laboratory managers a new tool in the diagnosis of septicemia

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Frost & Sullivan Report Identifies Molecular Diagnostics as Fastest-Growing Sector of Clinical Pathology Laboratory Testing
Annual growth rates of 11% or more is predicted for molecular diagnostics in coming years

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American Medical Association and PBS Both Join Pathology Profession in Publicizing Why Declining Autopsy Rates May Hurt Quality of Healthcare
Pathologists point out that autopsies consistently reveal doctors make a high rate of diagnostic errors—even with increasingly sophisticated imaging equipment

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The Joint Commission and SGS Now Offer Hospitals Coordinated Program for Medicare Accreditation and ISO 9001 Certification
Expect more hospitals and health systems to consider adopting the QMS of ISO 9001

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In Fixing Physician Medicare Pay, Congress Enacts Yet Another Cut in Clinical Laboratory Test Fee Schedule
A part of this legislation, the grandfather clause on Technical Component (TC) anatomic pathology services was extended through June 1, 2012.

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Decisions in Prometheus, Myriad, and Classen Cases Help Clarify Patent Eligibility Requirements for Genetic Lab Tests and Molecular Diagnostics
New Genomic X PRIZE goals/subjects accelerate the drive toward personalized medicine

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New Disinfection Technique for Hospital Rooms Will Be Useful to Clinical Pathology Laboratories
Vapor-based fumigant system could prove useful in disinfecting microbiology labs, clinical labs, and histology labs

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Sequencing Developers’ Unprecedented Success Drives More Ambitious Goals For Genomics X Prize
New Genomic X PRIZE goals/subjects accelerate the drive toward personalized medicine

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More Physician Use of EHRs Could Increase Medical Malpractice Claims
Because they provide medical lab test results to EHRs, clinical labs and pathologists are often named in medical malpractice lawsuits

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Fewer Biopsies Go to Pathology Labs when Gastroenterologists Use New Miniature Microscope
Advances in use of probe-based Confocal Laser Endomicroscopy (pCLE) could mean that GIs refer fewer specimens to clinical pathology laboratories

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Non-Invasive Early Diagnostic Pathology Test for Gastric Cancer Developed by University Of Georgia Researchers
New cancer test may be as easy as a home-use pregnancy test

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Good News for Clinical Labs and Phlebotomists: Safety-engineered Devices Reduce Needlestick Injuries
Hospital studies consistently show safety-engineered devices reduce needlestick injuries

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Blockbuster Pathology Deal Sees Japan’s Miraca Holdings Pay $725 Million to Acquire Caris Diagnostics
Deal may be just the first of more clinical laboratory acquisitions in the U.S by Japan’s largest medical lab testing company

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Concierge Medicine Trend Continues and Creates New Clients for Clinical Pathology Laboratories
MDVIP and similar concierge medicine companies are attracting patients willing to pay for improved access to physicians

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Vermont Enacts Nation’s First Single-Payer Healthcare System Amid Controversy
Still not known is how pathologists and clinical laboratories will be paid for medical lab tests

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Walgreens Introduces a Blood Glucose Testing Product for a Diabetes Management System That Links Pharmacists, Physicians, and Patients
Pathologists and clinical laboratory managers take note: pharmacies and retail stores are offering medical laboratory testing services that allow patients to take yet another test at home

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Many Hospitals and Doctors Not Happy with Federal Rules for Accountable Care Organizations (ACOs)
Major healthcare stakeholders speaking out with criticisms of federal ACO rules

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Quest Diagnostics Discloses Pending Agreement to Pay California $241 Million to Settle Medi-Cal Medical Laboratory Test Pricing Case
A final settlement between both parties may become the template state officials use to resolve Medi-Cal overcharge claims involving other clinical pathology laboratories.

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IFCC WorldLab 2013 Conference in Berlin Provides Look at Developing Trends in Clinical Laboratory Testing Products
IVD manufacturers often introduce their newest technologies in Europe before the United States.

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Severe Shortage of Pathologists Threatens Israel’s Health System—Especially Cancer Testing
Israel currently has about half the pathologists per capita as does the United States.

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Bad News for Clinical Pathology Laboratory Workers: Salaries Not Keeping Pace with Cost of Living Increases
Blame it on the recession of 2008-2010, but the findings are not auspicious for medical laboratories.

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Why Gen X makes it Four Generations Now Working in Clinical Pathology Laboratories
Managing a multi-generation medical laboratory workforce is a daunting challenge.

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Teaching the Next Generation of Clinical Pathology Laboratory Managers
MLO and The Dark Report award scholarship to Medical Technologist from Uganda

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Clinical Laboratory Company Quest Diagnostics Agrees to Acquire Celera Corp. for $657 Million
Celera is not a medical laboratory, but develops biomarkers and molecular diagnostics tests

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FDA Clears First Mobile Radiology Diagnostic App. Is Digital Pathology Next?Image quality of wireless device screens may already be good enough for basic digital pathology use

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Veterans Administration’s Website with Hospital Compare Website Delivers Improved Transparency to Patients
Efforts to improve transparency still don’t include clinical pathology lab data

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Pathologists Are Included in the Updated CMS “Physician Compare” Website
Medicare officials continue to work toward improved transparency in provider outcome

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Cyber-Attacks against Internet-Enabled Medical Devices are New Threat to Clinical Pathology Laboratories
Veterans Administration and Hospitals Taking Steps to Prevent Hacking of Medical Devices and Wireless Systems

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Good News for Clinical Pathology Laboratories: Medicare Officials Intend to Rescind Rule Requiring Physician Signatures on Paper Lab Reqs
CMS says it will take steps to rescind the final rule before its scheduled implementation on April 1, 2011

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Sonic Healthcare Buys California Clinical Pathology Laboratory Company
This Medical Laboratory Acquisition Positions Sonic in Nation’s Largest Lab Testing Market

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CDC Improvement Project Reports Big Drop in the Number of Hospital-Acquired Infections
Significant Number of Hospitals Participated in Effort to Improved Patient Outcomes

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Clinical Pathology Laboratories Have Opportunity to Learn More about ISO 15189
A2LA, CAP, and QMP-LS to Participate in an Informational Event on January 20th

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More Hospitals Advertise Shorter Patient Wait Times for Their Emergency Departments
New trend pressures clinical pathology laboratories to shorten turnaround times for key lab tests

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Boston Pathologists at the Forefront of Whole Human Genome Sequencing
1000 Genome Project publishes database of 800 whole human genome sequences

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Expert Says Accountable Care Organizations Must Embrace Patient Choice to be Successful
ACOs will change how clinical laboratories and pathology groups provide medical lab tests

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GE Healthcare Pays $587 Million to Purchase Clarient, the Specialty Pathology and Cancer Testing Firm
Here’s more confirmation that anatomic pathology continues to be a big target on the radar screen of big healthcare corporations and Wall Street investors. Today, GE Healthcare, a unit of General Electric Company (NYSE: GE), disclosed it will pay $587 million to acquire Clarient, Inc. (NASDAQ: CLRT), the medical testing laboratory.

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RedPath to be acquired by French company
RedPath Integrated Pathology Inc., based in Pittsburgh's Strip District area, has agreed to be acquired by Paris-based ExonHit Therapeutics. The deal is valued at $32 million, according to a press release from the companies, with an upfront payment of $12.5 million in cash and $10 million in stock, and starting in 2012 a subsequent additional payment up to $9.5 million, "dependent on the achievement of sales targets," according to the release.

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OIG Determines that CMS Failed to Report Disciplinary Actions against Clinical Pathology Laboratories and other Providers
Adverse actions taken by federal healthcare regulators against clinical pathology laboratories and other healthcare providers have not been reported to a public database as required by law. That is the finding of the Office of the Inspector General (OIG), based on its study of the information contained in the Healthcare Integrity and Protection Data Bank (HIPDB).

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Is “Meaningful Use” the Elephant in the Pathology Lab’s Living Room?
In 2011, physicians can earn federal incentives for adopting electronic medical record (EMR) systems and demonstrating “meaningful use.” Every clinical laboratory and pathology group must be ready to deal with this new development. That’s because hundreds of thousands of physicians are about to embark on EMR implementation in their practices—with or without laboratory participation.

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LabCorp to Acquire Genzyme’s Genetics Pathology Laboratory Testing Business for $925 Million
Laboratory Corporation of America (NYSE: LH) agreed to purchase Genzyme Genetics Corp’s. (NASDAQ: GENZ) fetal genetics and oncology testing division for $925 million in cash. Genzyme has shopped its neo-natal genetic testing business since last year.

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Cincinnati’s Health Alliance Dissolves, Was a Pioneer in Consolidation of Clinical Pathology Laboratory Testing
Back in the mid-1990s, Cincinnati was the location for a multi-hospital clinical laboratory consolidation that was one of the first and biggest of its time. Now, all but one of the original organizing hospitals of The Health Alliance of Greater Cincinnati have gone their separate ways.

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Sales of Electronic Medical Record (EMR) Systems to Physicians Will Double By End of 2012
Clinical laboratories and anatomic pathology groups may soon face the need to upgrade or switch their laboratory information system (LIS) to a version that is HIPAA 5010 and ICD-10 capable. This is likely to be an overlooked consequence of the mass adoption of electronic medical record (EMR) systems by physicians across the country.

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Alberta’s Next Round of Clinical Laboratory Consolidation Alarms Pathologists
Plans are to centralize all cervical cancer screening in just two Alberta medical laboratories

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Total Laboratory Automation Gives Clinical Pathology Labs More Ways to Achieve Significant Efficiency and Savings
TLA and other laboratory automation solutions help clinical labs cope with shortage medical technologists

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Molecular Diagnostics Laboratory in a Suitcase Travels to Farms to Test Livestock
New molecular point-of-care testing systems already being tested in several African countries

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Details Issued Today on $1 Billion in Biotech Tax Credits and Grants
Small to Mid-Sized Firms Should Waste No Time in Applying for Key Federal Incentives, Attorney Says.

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Three Reasons to Invest in Personalized Medicine
Iris BioTechnologies (IRSB), Genomic Health (GHDX) and Affymetrix (AFFX) are three of the major players in one of the hottest fields in biotechnology today – personalized and targeted medicine. While Affymetrix, the industry leader in microarray technology, has dominated the research arena, Genomic Health has helped bring molecular diagnostics technology to the clinician paving the way for an early adoption of Iris’s more advanced technologies, products, and services.

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Rosetta Genomics to Present at the 6th Annual Rodman and Renshaw ...
Rosetta Genomics is a leading developer of microRNA-based molecular diagnostics. Founded in 2000, the company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of ...

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GE Healthcare Forms Strategic Alliance with Cardiovascular Genomic Diagnostic Company, CardioDx
... Fund targets three broad areas for investment: Broad-based Diagnostics, including imaging, home health, patient monitoring, molecular diagnostics, ...

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Discovery Of New Approach For Identifying Smokers At Highest Risk For Developing Lung Cancer
Spira is one of the founders of Allegro Diagnostics Inc. , a molecular diagnostics company that plans to market the gene expression biomarker. Source: Gina DiGravioBoston University Medical Center Any medical information published on ...

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PerkinElmer Enters Into Agreement to Acquire Signature Genomic Laboratories, LLC
Acquisition brings new diagnostic services to global leader in pre-natal and newborn health screening.

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Medical Diagnostics: Five Health Care Reform Beneficiaries
"There are also people who avoid the doctor's office, not because they're afraid of needles, but because they can't afford it," says growth stock specialist Marc Lichtenfeld.

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AACR 2009: Measuring Circulating Tumor Cells Is Clinically Useful, New Technique Promises to Be Faster

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Predictive Biosciences to Present Novel Combination Approach to Molecular Cancer Diagnostics at 2010 Genitourinary Cancers Symposium
Predictive Biosciences today announced that the Company will be presenting its novel Multi-Analyte Diagnostic Readout (MADR™) approach to the development of a non-invasive, urinary biomarker based assay for the detection of bladder cancer during the 2010 Genitourinary Cancers Symposium (GU Symposium), being held March 5-7 in San Francisco. The GU Symposium is co-sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO). The MADR research, which combines protein and DNA biomarkers to identify with high certainty a group of bladder cancer patients who are disease free and could be excluded from undergoing invasive procedures, was conducted under collaboration agreements with Lahey Clinic Medical Center and Mayo Clinic.

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BHL litigation against Health Diagnostic Laboratory: Celera addresses business impact
Celera Corporation (NASDAQ:CRA) today provided information on litigation filed by Berkeley HeartLab, Inc. (“BHL”), Celera’s wholly-owned subsidiary, against Health Diagnostic Laboratory, Inc. and several former employees of BHL, including five sales representatives who left the Company on January 1, 2010, and two former laboratory employees. BHL has filed a complaint seeking injunctive relief and damages in the United States District Court for the Eastern District of Virginia. In the litigation, BHL has asserted a number of contractual, tort and statutory claims against the defendants, including claims for misappropriation of trade secrets and tortious interference with BHL’s client relationships. The defendants’ activities have been concentrated in the Southeast, which historically has been the highest-volume sales territory for BHL.

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A better genetic test for autism - In largest study to date, chromosomal microarray analysis picks up more abnormalities than current tests
A large study from Children's Hospital Boston and the Boston-based Autism Consortium finds that a genetic test that samples the entire genome, known as chromosomal microarray analysis, has about three times the detection rate for genetic changes related to autism spectrum disorders (ASDs) than standard tests. Publishing in the April issue of Pediatrics (and online March 15), the authors urge that CMA become part of the first-line genetic work-up for ASDs.

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Merger of Spectrum Laboratory Network and Carilion Labs Creates Big Clinical Laboratory Company
Spectrum Laboratory Network of Greensboro, North Carolina announced a merger with Carilion Labs of Roanoke, Virginia. The combined enterprise will have annual revenue of approximately $300 million and immediately becomes one of the nation’s larger clinical laboratory companies.

Read more at DarkDaily.com



Gates Foundation funds $5 million in biomarker research
The non-profit Catalysis Foundation for Health has been awarded $5 million from the Bill and Melinda Gates Foundation to help discover new tuburculosis biomarkers. The goal is to develop bacterial load diagnostics to improve treatment options and potential develop new treatments.

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Duke University opens new molecular research facility
A new $5.3 million research facility at Duke University Medical Center will focus on the early-stage “first-in-human” research of new drug and device candidates using biology and molecular medicine approaches.

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IT talent takes on greater role as EMRs ramp up
The Obama administration is hoping to achieve a 95% adoption rate among doctor’s offices for Electronic Medic Records (EMRs) over the next four year ’s. This will increase pressure on laboratories to develop highly functional interface systems to coordinate with doctors. Currently less than 25% of physicians are using EMRs regularly, but with approximately $18 billion in financial incentives for doctors, the adoption rate could increase drastically.

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