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Apheresis News Volume 2.03

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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April 04, 2007  // Volume 2.03
TOP STORY
Blood Made Suitable for All
Scientists have discovered enzymes that can efficiently convert blood groups A, B and AB into the 'universal' O group — which can be given to anyone but is always in short supply.
SCIENCE
 

New Lease on Shelf Life for Blood
Australian scientists have discovered the trick to extending the shelf life of a vital blood product relied on by thousands of cancer sufferers.

Aethlon Medical Initiates Dengue Fever Studies with Government of India Researchers
Aethlon Medical, Inc., announced today that it has manufactured and shipped Hemopurifier(R) treatment cartridges for studies related to the treatment of Dengue Hemorrhagic Fever (DHF), an international health issue untreatable with antiviral drug and vaccine therapy.

Aethlon Medical Announces FDA Submission
Aethlon Medical, Inc. has announced that it has submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) requesting permission to initiate human safety studies of the Aethlon Hemopurifier(R) as a treatment countermeasure against select category "A" bioterror threats.

Arbios Systems Reports Favorable Results From the SEPET(TM) Feasibility Clinical Trial
Arbios Systems, Inc. has announced further favorable, preliminary results following the enrollment of 15 patients in the feasibility clinical trial of its SEPET(TM) Liver Assist Device.

Artificial Vein to Boost Surgery
Scientists are developing an artificial vein for use in patients with circulation problems.

Talecris Launches Trial Exploring Use of Plasma Ingredient To Treat Blood Flow
The trial will focus on the use of Plasmin, which is derived from plasma, to treat acute peripheral arterial occlusion, or aPAO.

University of Wisconsin School of Medicine Launches Study Testing Adult Stem Cells for Heart Damage Repair
The University of Wisconsin School of Medicine and Public Health is among the first medical centers in the country taking part in a novel clinical trial investigating if a subject's own stem cells can treat a form of severe coronary artery disease.

Immucor Submits Device to FDA
Immucor, Inc., a global leader in providing automated instrument-reagent systems to the blood transfusion industry, announced that the company has submitted the 510(k) premarket notification submission for its Galileo? Echo? instrument to the U.S. Food and Drug Administration.

Verax Biomedical Submits 510(k) Application To FDA For Platelet PGD Test
This filing is based on data gathered at three major U.S. hospitals and is intended to demonstrate that the performance of the product is substantially equivalent to existing FDA cleared tests for the detection of bacterial contamination in platelets.

Roche Seeks OK of Blood Screening Test
Roche Diagnostics has said that it is seeking approval for U.S. sales of its blood screening test that detects a broader range of HIV/hepatitis.

FDA Approves Rhophylac(R) for the Treatment of Immune Thrombocytopenic Purpura (ITP)
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for an additional indication for Rhophylac Rh(0)(D) (Immune Globulin Intravenous [Human]), an anti-D Rh immunoglobulin (Ig).

An Easier Way to Find Veins
A new device uses infrared light to help nurses and phlebotomists, who specialize in drawing blood, locate veins.

Doctors Take Recycling to Heart
A new device recycles patient's blood during surgery.

Inquiry Opens into Blood Contamination Deaths
An independent inquiry began today into the deaths of nearly 2,000 haemophilia patients exposed to HIV and/or hepatitis C through contaminated blood and blood products, described as the worst treatment catastrophe in NHS history.

American Society for Clinical Pathology Board of Registry Awarded Accreditation by ANSI
The ASCP is proud to report that on Friday, March 9th, 2007, the ASCP Board of Registry (BOR) was awarded accreditation by the American National Standards Institute (ANSI) for a period of five years.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Factors Influencing Engraftment in Autologous Peripheral Hematopoetic Stem Cell Transplantation (PBSCT)
Autologous peripheral blood stem cells transplantation (PBSCT) is a therapeutic option which can be used in various hematological neoplastic disorders; and it can prolong disease free survival and total survival and at times it may be curative. In this study, the researchers investigated variables influencing PBSCT in 91 patients who had undergone PBSCT between 1998 and 2002 in their center, retrospectively.

Extracorporeal Photochemotherapy for the Treatment of Chronic Graft-Versus-Host Disease: Trend for a Possible Cell Dose-Related Effect?
Extracorporeal photochemotherapy (ECP) has been progressively introduced into the treatment of both acute and chronic graft-versus-host disease (cGvHD) over the last decade. Nevertheless, its mechanisms of action, as well as the optimal treatment schedule, have not yet been defined. The researchers retrospectively analyzed 25 patients with cGvHD unresponsive to conventional treatments who underwent ECP from 1997 until 2005.

BUSINESS
 

Blood Bank Uses New Technology
Siouxland Community Blood Bank is the first in the nation to introduce the Cymbal System created by Haemonetics.

New Blood Bank for Pets Launched
Pet Blood Bank UK is billed as the first service to offer vets a nationwide supply of blood to treat small animals.

NeoStem Announces Expansion of Nationwide Network of Cutting-Edge Adult Stem Cell Collection Centers
NeoStem, Inc. has announced that the Company has executed an agreement to open an Adult Stem Cell Collection Center in Las Vegas, Nevada.

JBC Builds $200 Million Blood Derivative Factory in Madinah
The new company, registered under the name "Blood Derivatives International Co. Ltd.", will be built at a cost of $200 million and projected to have an annual production capacity of 500MT of plasma.

Grifols Announces Expansion of US Manufacturing Capacity
At a meeting in Los Angeles, California, Grifols' Executive Committee decided to put into service existing manufacturing capacity of 700,000 liters of plasma.

Fresenius Medical Care to Offer Nephrology Electronic Health Record System for Chronic Kidney Disease
Fresenius Medical Care AG & Co. KGaA has announced that is has entered into an agreement with Health IT Services Group to license its Web-based electronic health record for nephrologists in the United States to be marketed as Fresenius Medical Care CKD Solutions.

Dialysis Corporation of America Announces Acquisition of Pennsylvania Dialysis Center
Dialysis Corporation of America announced the acquisition of a dialysis center in Selinsgrove, PA. The center has a total of 10 treatment stations, and an anticipated initial patient census of approximately 40 patients.

Commonwealth Serum Laboratories Denies it Underpays its Plasma Donors
The chief of CSL has rejected suggestions that the Australian blood products maker is underpaying plasma donors as the company expands its margins.

Life Therapeutics Approves $80m Buy Back
Biotechnology company Life Therapeutics has unanimously approved an on-market buy back of up to $80 million in shares, pending the sale of a US-based subsidiary.

HemaCare Reports 12% Growth in 2006 Net Earnings on Record Revenue
The Company reported record revenues of $10.7 million for the quarter, an increase of 21% from the prior-year period.

Pilgrim Software Spearheads Formation of the Worldwide Blood Forum
Pilgrim Software, Inc. has announced the formation of the Worldwide Blood Forum, an international consortium of Blood Services representatives. The members of this Forum will engage in ongoing dialogue to exchange recommendations for enhancing Pilgrim's solutions to most effectively serve the current needs of its customers within the blood industry.

NxStage(R) Medical and Renal Advantage Collaborate to Increase Awareness and Availability of Home Hemodialysis Therapies
As part of an agreement signed in February 2007, the companies will work together to increase the availability of home hemodialysis therapy to patients who may benefit and will collaborate on therapy development in selected strategic markets that Renal Advantage serves.

A Wikipedia-style Site for Medical Information
Four doctors at the Cleveland Clinic are drawing international attention with a medical version of Wikipedia, the popular online encyclopedia that anyone can edit.

Aethlon Medical Files Cancer Treatment Patent
Aethlon Medical, Inc. disclosed that it has filed a international patent application under the Patent Cooperation Treaty (PCT) entitled, Extracorporeal Removal of Microvesicular Particles.

Arbios Systems Strengthens Its Proprietary Position for Blood Filtration Therapies in Critical Care Medicine
Arbios Systems, Inc. has announced the in-licensing of a patent portfolio of issued U.S. patents as well as pending U.S. and foreign applications and other intellectual property. The exclusive license includes five issued U.S. patents with broad claims for methods of treating liver failure, multi-organ failure, multi-organ dysfunction syndrome, sepsis, septic shock, systemic inflammatory response syndrome, and related inflammatory disorders by selective blood filtration.

ThermoGenesis Lands Three Patents
Rancho Cordova-based ThermoGenesis Corp. has received three U.S. patents for its AutoXpress stem cell processing system and its CryoSeal surgical glue devices.

Lifebank Re-Appoints Owen Granger as CFO
Lifebank Corp. is pleased to announce that it has re-appointed Owen Granger as its Chief Financial Officer. Mr. Granger is a Certified Management Accountant with over 20 years of experience in senior finance and accounting positions with public reporting enterprises. He previously served as Chief Financial Officer and a Director of Lifebank from 2000 to 2005.

FUNDING & PROGRAMS
 

Baxter Announces 2007 Renal Discoveries Grant Program To Advance Science And Care For Kidney Disease Patients
Baxter Healthcare Corporation announced 2007 funding and application deadlines for its Renal Discoveries Extramural Grant Program (EGP), which is focused on patient-oriented research in academic nephrology training centers around the world. Four grants will be awarded and funded in 2007 - one each in Asia/Pacific, Latin America, North America and Europe/Middle East/Africa/Russia.

Notice Clarifying Implementation Dates for Change in NINR R03 Applicant Eligibility (NOT-NR-07-003)

Institutional Clinical and Translational Science Award (U54) (RFA-RM-07-007)

Correction for PAR-07-024: Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies (R01) (NOT-DK-07-006)

Notice of Intent to Issue a PA on Investigator-Initiated Multi-Site Clinical Trials (NOT-HL-07-108)

REGULATORY
 

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

MLN Matters Number MM5464 – Extracorporeal Photopheresis

CMS Breaking News Regarding Form CMS-1500
It has come to our attention that there are incorrectly formatted versions of the revised form. Given, the circumstances, CMS has decided to extend the acceptance period of the Form CMS-1500-(12-90) version beyond the original April 1, 2007 deadline while this situation is resolved. Contractors will be directed to continue to accept the Form CMS-1500 (12-90) until notified by CMS to cease.

Medicare Evidence Development & Coverage Advisory Committee Updated Roster Posted

2007 Physician Quality Reporting Initiative PowerPoint Module One

 
FOOD AND DRUG ADMINISTRATION (United States of America)

Recall of Medical Devices - Biomet Biologics, Inc.

Important Notification: Fast Flow Fluid Warmers - Smiths Medical

Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products

FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs)
The U.S. Food and Drug Administration (FDA) today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia.

User Fee Billable Products Approved Under Section 351 of the PHS Act - Update

Manual of Standard Operating Procedures and Policies Regulatory - License Applications Administrative Processing of Biologics License Applications (BLA)

Draft Guidance for Industry and FDA Staff: Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making

Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting

Approved Biological Premarket Approval (PMA) Device Applications - Update

Cleared Biological 510(k) Device Applications - Update

Request for Nominations for Voting Members on Public Advisory Committees (Including Blood Products Advisory Committee)

 
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Proposals for MHRA Fees for Medicines and Blood Banks and Establishments from April 1, 2007

Public Consultation (RCX/004/002/035): MHRA Regulatory Fees for Medical Devices - Proposals for April 1, 2007

Proposed Increase to Medical Devices Fees

Medical Device Alert - Haemodialysis machine: Integra manufactured by Gambro

 
CANADIAN BLOOD SERVICES (Canada)

Blood Services Extends Deferral Time for People Who've Travelled to Malaria Zones
Canadian Blood Services is asking people who have travelled to areas where malaria circulates to stay out of the donation pool for a little longer than they used to.

 
NATIONAL HEALTH SERVICE (Wales)

'Safer' Claim for Blood Barcodes
A new blood bar-coding system has been introduced in north west Wales, which health officials claim will provide tighter safety controls for patients.


HEALTH PROTECTION AGENCY (United Kingdom)

Majority in Favour of vCJD Blood Test
Most members of the medical community would like to see a vCJD test introduced for blood donations provided technical challenges are overcome, a survey carried out by the Health Protection Agency (HPA) has found.


DEPARTMENT OF HEALTH AND AGEING (Australia)

Abbott Will Not Lift Mad Cow Blood Ban
TONY Abbott has agreed not to lift a blood ban imposed in the wake of the outbreak of mad cow disease in Britain.

Abbott About Face on Blood Market Reform
Federal Health Minister Tony Abbott says the Howard government will no longer push for reform within Australia's blood supply market. 

ASFA
 

Register to Attend the 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.

Register for the 2007 Annual Meeting today!

Click Here to Register Now

 

Advertise Your Apheresis Job Posting at the ASFA 2007 Annual Meeting

Are you interested in recruiting for an apheresis-related position for your company or institution?

ASFA invites you to post your position in a special print edition of the ASFA Newsflash dedicated to apheresis career opportunities. This special print edition will be distributed to a captive audience of over 700 apheresis professionals at the ASFA 2007 Annual Meeting.

As an added bonus, your career posting will be posted on the ASFA website and an email will be sent to all meeting delegates (and all ASFA members) in advance of the Annual Meeting pointing them to the online posting. This will allow interested candidates to express their interest in your position in advance of the meeting. You could even set up an in-person interview at the ASFA 2007 Annual Meeting!

This unique recruiting opportunity is available for only $500 per career posting.

To take advantage of this offer, complete the form at the link below and send, along with payment information, via email to asfa@apheresis.org or via fax to 604.874.4378 by April 5, 2007.

Click Here to Download the Career Posting Form

 
JOB OPPORTUNITIES
 

Director of Therapeutic Apheresis - Registered Nurse
HemaCare

Chief Executive Officer (CEO)
Community Blood Center/Community Tissue Services (CBS/CTS), Dayton, Ohio

FEATURED EVENT
 
International Society of Blood Transfusion Annual Congress
Event Date: June 23-27, 2007
Event Location: Madrid, Spain
MEET US AT ASFA
 

Apheresis News is exhibiting at the Annual Meeting of the American Society for Apheresis

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We're interested in your feedback, and want to show you how Apheresis News can help you reach your audience and stay informed.

Stop by booth #218 or book a meeting with us by emailing info@apheresisnews.com.

 
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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