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Apheresis News Volume 2.0

Apheresis News facilitates the exchange of information and resources between members of the global apheresis community by providing a website portal and free, monthly e-newsletter dedicated to the latest information affecting apheresis.
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January 10, 2007  // Volume 2.0
TOP STORY

Extracorporeal Photopheresis Posted Decision Memo

FDA Approves First Test to Screen Blood Donors for Chagas Disease
The U.S. Food and Drug Administration (FDA) today approved a new test to screen blood donors for a blood-borne parasite that causes Chagas disease, a serious and potentially fatal parasitic infection.

SCIENCE

Prion Filter Could Prevent VCJD Spread From Donated Blood
Scientists have found a way to remove disease-causing proteins from infected animal blood, which they hope may fight the human form of mad cow disease.

Gene-engineered Cattle Resist Mad Cow Disease
The cattle are engineered to lack the nervous system prions, a type of protein, that cause BSE and other related diseases such as scrapie in sheep and Creutzfeldt-Jakob disease, known as CJD, in humans.

Better Catheter Hygiene Could Save Lives
Simple hygiene can help hospitals to nearly eliminate deadly bloodstream infections related to catheter use.

Celsus to Commence Phase I Clinical Studies of Intimatan
Intimatan(TM) is an improved anti-inflammatory anticoagulant intended for use in indications dominated by heparin.

Magnets Take the Spin Out of Blood Separation
A physicist in the US has proposed a new way to separate red and white blood cells using a magnetic field.

PACS Stem Cell Purifier
ValiRx Morphogenesis unit have developed a new, in-line, cell purification device that allows stem cells to be selectively and efficiently removed from a blood sample in a more patient-friendly manner.

Ciphergen Announces Presentation of Data Demonstrating Use of Diagnostic Test to Monitor Blood Disorder
Ciphergen Biosystems, Inc. has announced that its clinical development partner Ohio State University presented data demonstrating the clinical utility of its assay to manage patients with thrombotic thrombocytopenic purpura (TTP), a hematologic disease.

ELAD(R) Bioartificial Liver Trial in China Achieves Significance at Halfway Point
Vital Therapies, Inc. (VTI) announced today that it has completed the interim analysis of the first 45 patients enrolled in its controlled, randomized, two-center, single-treatment trial in China for the ELAD(R) (Extracorporeal Liver Assist Device) System.

Blood Transfusions Raise Heart Patients' Infection And Death Risk - Especially Women
A new study suggests that patients who receive transfusions during heart bypass surgery have a higher risk of developing potentially dangerous infections, and dying, after their operation.

Northfield Labs’ Blood Substitute Fails to Meet Goal in Clinical Trial
In a potential blow to the future of an Evanston-based biotech company, a clinical trial has shown that its key product, an experimental blood substitute, performed worse than standard treatments in patients who suffered traumatic injuries.

New Hemopure Study Planned
Biopure Corp., which develops blood substitution products, has said that the Navy is talking to the Food and Drug Administration about changes to a proposed clinical trial for Hemopure after an advisory panel voted against recommending the current study design.

RFID Pilot Project Aims to Improve Blood Banks
To find out whether radio frequency identification can improve the speed and accuracy of the blood banking process, the RFID Lab at the University of Wisconsin-Madison is partnering with three blood banks and multiple vendor partners on what is being called an "end-to-end" research project.

Monkey Handlers Cannot Give Blood
People who work with monkeys can no longer give blood because of fears they may spread a virus similar to HIV.

New Guidelines for Blood Supply
With the nation's blood supply safeguarded against AIDS, hepatitis, syphilis and West Nile virus, blood banks are starting to address more esoteric threats -- from Chagas disease to a potentially deadly protein.

Changes to Transfusion Rules Leave Donor's Blood Boiling
A blood donor has been told he will have to travel to England to continue giving blood because the Scottish transfusion service cannot screen him for a jungle disease.

Lethal Risk from Blood Transfusion
Two deaths are being investigated and dozens of other Australians are at risk because the type of blood they received in transfusions was not screened for potentially lethal bacteria.

Hospitals Refuse to Warn of Bone Contamination
Three hospitals are refusing to inform patients that they may be contaminated with bone illegally harvested from cadavers in the United States, including the body of the late BBC broadcaster Alistair Cooke.

American Red Cross Responds to $5.7 Million FDA Fine
The American Red Cross has plans to hire an external consultant and create a new oversight committee in response to a $5.7 million federal fine for violating blood-safety laws and a 2003 consent decree.

Hospital CIOs Across Country Tackle Demanding Projects in 2007
As 2007 dawns, CIOs at healthcare organizations across the country are gearing up for major IT revamps. They run the gamut from rolling out new clinical systems, installing new servers, and boosting wireless capacity.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Pathogen-reduction Systems for Blood Components: The Current Position and Future Trends
This overview aims to provide an update on the continual improvements in blood component safety, in particular using methods that target pathogen nucleic acid.

Prospective Evaluation of Double RBC Collection Using Three Different Apheresis Systems
30 blood donors were randomly assigned to double RBC collection with either the Baxter Alyx (AX), the Haemonetics MCS Plus (MCS+), or the Gambro Trima Accel (TA). Procedures were prospectively evaluated focussing on yield, time, efficiency, citrate donor load, and in vitro quality.

BUSINESS

NeoStem Announces Five-Year Agreement with Hemacare for Adult Stem Cell Collection Services
NeoStem, Inc. has announced a five-year agreement with HemaCare Corporation to provide NeoStem with collection services for the procurement of adult stem cells from peripheral blood for the purpose of long-term storage.

Firm Pioneers Banking Blood for Future
By the end of this month patients in London and other areas of England will also be able to take advantage of the potential life-saving treatment, which has been described as a form of "biological life insurance".

Aethlon Medical Announces Dengue Virus Collaboration With Government of India Researchers
Aethlon Medical, Inc. has announced that it has agreed to collaborate with researchers at the National Institute of Virology (NIV) to initiate testing its Hemopurifer(TM) technology as a potential treatment for Dengue Hemorrhagic Fever.

3M System Helps Mayo Clinic Store Tissue Samples
Maplewood-based 3M Co. and Mayo Clinic has announced that they have installed a successful pilot program using radio frequency identification (RFID) technology from 3M in the Mayo Clinic's endoscopies, where patient tissue samples are collected.

Mediware Delivers Integration between HCLL(TM) Blood Bank and McKesson’s Horizon Lab(TM)
Mediware Information Systems has announced that it has successfully implemented HCLL(TM) Transfusion at the University of Toledo Medical Center (UTMC), automating transfusion services for the hospital’s blood bank.

BTG Licenses Haemofiltration Device Patents to Fresenius for 4.5 Million Euros
The device improves the treatment of acute renal failure by enabling automated adjustments to be made during a haemofiltration session, reducing the possibility of human error and the need for supervision.

Cerus Receives $5 Million Milestone Payment
Cerus Corp., which is developing systems designed to purify donated blood, has said it received a $5 million cash payment from BioOne Corp. after its Intercept blood system was approved for plasma by European regulators.

Verax Biomedical Taps British Biocell to Manufacture Platelet PGD Tests
Verax Biomedical Inc., a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has signed a 10-year agreement with British Biocell International (BBI) to manufacture the Verax Platelet PGD(R) Test. Under terms of the agreement, BBI could produce as many as 50 million tests and will establish a second manufacturing facility to handle Verax production.

TMC Ventures Into Stem Cell Banking
TMC Life Sciences Bhd is venturing into cord blood and adult stem cell banking, therapy, application and research and development and has set up a dedicated subsidiary TMC Stemcells Sdn Bhd for that purpose.

AngioDynamics to Acquire RITA Medical for $220 Million
AngioDynamics, Inc. a manufacturer of medical devices for the diagnosis and treatment of peripheral vascular diseases and other non-coronary diseases will takeover RITA Medical Systems, Inc., a provider of medical oncology devices, for approximately $220 million.

Renal Advantage Completes Lab Purchase
Dialysis services provider Renal Advantage Inc. has completed its acquisition of RenaLab from Fresenius Medical Care North America.

WellBound Continues Expansion With Opening of Latest Self-Care Dialysis Center
WellBound, the first company focused exclusively on supporting the full spectrum of self-care dialysis therapies, today announced the official opening of its ninth specialized self-care dialysis center.

The Homeland Defense Journal Reports on Aethlon Medical in Bioterrorism Feature Article
Aethlon Medical, Inc., a pioneer in developing therapeutic devices for infectious disease, disclosed today that it is featured in a bioterrorism industry article published in the latest issue of The Homeland Defense Journal.

Optimata Granted Patent for Modeling Thrombopoiesis
Optimata Ltd. announced today that it has been granted U.S. Patent 7,133,814 for inventing a system that models the development of thrombopoiesis in humans. The invention enables simulating the thrombopoietic process in virtual patients where different therapies are applied.

Commercial Blood Banks on Way Out
Standalone commercial blood banks in the State are to soon go out of operation following a Government decision to stop renewal of their licences.

Virginia Blood Services Gets Makeover
Blood services' new look will comply with European standards.

FUNDING & PROGRAMS

Government to Fund Nearly $26 Million in Ambulatory IT Projects
The Agency for Healthcare Research and Quality has launched the Ambulatory Safety and Quality Grant Initiative, with a potential for granting as much as $25.8 million for healthcare IT projects.

Stem Cells and Cancer (R01) (PA-07-187)

Interim Guidance on Salary Limitation for Grants, Cooperative Agreements and Contracts (NOT-OD-07-033)

Innovations In Cancer Sample Preparation (R21) (RFA-CA-07-037)

Innovations In Cancer Sample Preparation (R33) (RFA-CA-07-038)

American Society for Apheresis Best Abstract Awards
Ten awards valued at $1500 each will be awarded to ASFA members and non-members.

REGULATORY

Congress Reverses Physician Payment Cuts

CENTERS FOR MEDICARE AND MEDICAID SERVICES (United States of America)

Briefing on Employee Education about False Claims Recovery

Medicare Evidence Development & Coverage Advisory Committee

Factors CMS Considers in Referring Topics to the Medicare Evidence Development & Coverage Advisory Committee

Updated List of Drugs Available Under the Competitive Acquisition Program

Many Part B Local Coverage Determinations (LCDs) Revised

Hospital Outpatient Prospective Payment System Fact Sheet

Understanding the Remittance Advice for Professional Providers Web-based Training (WBT) Course Now Available Through the Medicare Learning Network

FOOD AND DRUG ADMINISTRATION (United States of America)

FDA Warns of Blood Clots After Ending Heparin Use
The U.S. Food and Drug Administration and Baxter International Inc. has notified doctors that the drug Heparin could be linked to thrombosis or blood clots in patients several weeks after they stop taking it.

FDA Eyes Factor VIII Products
The Food and Drug Administration is set to examine Friday whether plasma-derived factor VIII products pose a risk of transmitting human mad cow disease and hemophilia patient advocates are urging stricter surveillance and oversight.

Tissue Banks May Get Rules
A state House committee, reacting to the federal shutdown last year of a Raleigh human tissue procurer, is preparing to propose basic rules for tissue banks.

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis - Update

Draft Guidance for Industry and FDA Staff - Radio-Frequency Wireless Technology in Medical Devices

Medical Device Regulations; Disqualification of a Clinical Investigator; Final Rule; Technical Amendment

Information for Healthcare Professionals Erythropoiesis Stimulating Agents (ESA) [Aranesp (darbepoetin), Epogen (epoetin alfa), and Procrit (epoetin alfa)]


DEPARTMENT OF HEALTH AND HUMAN SERVICES (Unites States of American)

January 11 and 12, 2007 Meeting of the Advisory Committee on Blood Safety and Availability (ACBSA) Cancelled (US DHHS)


HEALTH CANADA (Canada)

Association of Increased Mortality and Risk of Serious Adverse Events When Prophylactic Low-dose Heparin is Abruptly Discontinued in Patients to be Started on Xigris® [drotrecogin alfa (activated)] Therapy for Severe Sepsis


MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Medical Device Alert: Reporting Medical Device Adverse Incidents and Disseminating Medical Device Alerts

Medical Device Alert: Monthly list of MDAs - 2006

Field Safety Notice: Dialysis Machine - Gambro Lundia AB (Monitor Division) - CWP100

Blood Safety and Quality Regulations Seminar


NATIONAL HEALTH SERVICE (United Kingdom)

Patient Veto for E-care Records
The government is pushing ahead with the controversial electronic care records system - but has agreed to give patients a veto.


THERAPEUTIC GOODS ADMINISTRATION (Australia)

Review Takes Shot at the Business of Blood
Australia should not allow locally-donated blood plasma to be processed overseas and needed to apply more scrutiny to foreign manufacturers whose products are used to cover domestic shortfalls, according to an independent review commissioned by the Howard Government.

No National Blood Talks Till March 2007
The federal government will not intervene to bring in universal screening of blood used in transfusions despite Victorian coronial investigations into two deaths involving contaminated blood products.

ASFA

ASFA 2007 ANNUAL MEETING

The ASFA 2007 Annual Meeting will be held in Nashville, from April 18 – 21, 2007 at the Gaylord Opryland Resort & Convention.

Registration is now open -- be sure to register before March 5, 2007 to take advantage of the early registration fees. Hotel accommodation is also now available. Again, make your reservations early to take advantage of the special conference rate of $169/night (plus applicable taxes and $10/night mandatory resort fee). Contact the Gaylord Opryland Resort and Convention Center, stating that you are attending the ASFA 2007 Annual Meeting, at 1.866.972.6779 to make your hotel reservation today!

Visit http://www.apheresis.org/Registration/ to register for the Annual Meeting today.

JOB OPPORTUNITIES

Apheresis Nurse (Full Time)
The National Institute on Aging (NIA)/MedStar Research Institute (MRI)

Assistant/Associate Professor Rank
Division of Laboratory Medicine, Department of Pathology at the University of Alabama at Birmingham

FEATURED EVENT

1st IPFA/APBN Workshop - Safety and Supply of Blood and Plasma Products
May 15-16, 2007
Kyoto, Japan

For further event information, click here.

WEBSITE PREVIEW

The Apheresis News website features information on apheresis events, publications, regulatory bodies, associations, jobs, and products. Please visit www.apheresisnews.com to access these resources.

JOURNALS

Blood Purification
"Practical information on hemodialysis, hemofiltration, peritoneal dialysis and plasma filtration is featured in this journal. Recognizing the critical importance of equipment and procedures, particular emphasis has been placed on reports, drawn from a wide range of fields, describing technical advances and improvements in methodology."

Transfusion & Apheresis Science
"Transfusion and Apheresis Science (previously called Transfusion Science) brings comprehensive and up-to-date information to physicians and health care professionals involved in the rapidly changing fields of transfusion medicine and apheresis."

This newsletter is intended to be a useful and timely reference for those working or interested in apheresis. Because of the constantly changing nature of the Internet, some of the website links included herein may change without notice.
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