Navigation Links
Verax Biomedical Receives 510 (k) Clearance from FDA for Platelet PGD Test
Date:9/19/2007

First rapid test cleared for the detection of bacterial contamination in

platelets

WORCESTER, Mass., Sept. 19 /PRNewswire/ -- Verax Biomedical Inc., a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has received 510 (k) clearance for its Platelet PGD Test System from the U.S. Food and Drug Administration (FDA). This provides Verax authorization to market the device, which cuts the detection time for bacterial contamination in leukocyte reduced apheresis platelets to approximately 30 minutes.

The clearance comes on the heels of the execution of key agreements with Abbott Diagnostics to serve as distributor and British Biocell International to serve as manufacturer of the product. The data from US clinical studies that served as the basis of the Company's 510 (k) filing will be featured in 7 poster presentations at the upcoming Annual Meeting of the American Association of Blood Banks (AABB) in Anaheim, California October 20th - 23rd.

To combat the risk of bacterial contamination, the AABB requires all of its members to detect and limit contamination in platelets. Recent articles published in Transfusion, the journal of the AABB, indicate that current culture testing methods fail to detect half of the contaminated units in the U.S. inventory and false negative results associated with this testing have resulted in 26 documented septic transfusion reactions including 5 fatalities since testing began in 2004. The Platelet PGD test is designed to allow testing after platelets have entered the inventory and offers clinicians the opportunity to detect contaminated units that slip past current testing methodologies.

"We are thrilled to achieve this critical milestone," said Jim Lousararian, chief executive officer of Verax Biomedical. "The increasing recognition of culture false negative results associated with current platelet testing clearly illustrates the nee
'/>"/>

SOURCE Verax Biomedical Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Biomedical engineering conference invites manufacturers
2. Manufacturing partnership will move into biotech and biomedical spaces
3. Biomedical Alliance about more than stem cells
4. Doyle seeks $2.5M for biomedical alliance
5. Students will show off biomedical devices to professors and investors
6. Biomedical alliance marks first full year
7. UW Biomedical Engineering awarded $2.9 million research grant
8. Having two biomedical tech centers in Wisconsin will help the state
9. New biomedical institute aims to unite business and academia in SE Wisconsin
10. Wisconsin publicly traded biomedical companies report gains this quarter
11. Medical College receives $377K to study brain disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... Over the last decade, the laboratory filtration ... budgets and increased acceptance of new filtration technologies in ... industries are also catalyzing the growth of laboratory filtration ... to grow at a strong CAGR during the forecast ... $2,532.6 million by 2019. The market is mainly driven ...
(Date:9/30/2014)... 30, 2014 Follow us on ... each type of cholesterol carrier or lipoprotein in the ... excessive cholesterol levels in the body, especially along the ... heart attack and other cardiovascular disorders. Cardiovascular Diseases (CVD) ... for cholesterol levels on a regular basis, to assess ...
(Date:9/30/2014)... 2014 CORD:USE Cord Blood Bank – ... has entered into an Equity and Exclusive Services Agreement ... series of patented technologies for the isolation of human ... Tianhe is performing Phase I/II clinical trials in ... using Tianhe,s Stem Cell Educator Therapy showing that ...
(Date:9/30/2014)... Genedata, a leading provider ... and related life science research, today announced ... Selector as its host-pathogen data analysis platform ... a European consortium dedicated to improving the ... anti-fungal drug therapies. Genedata Selector supports this ...
Breaking Biology Technology:Global Laboratory Filtration Market To See 7.0% CAGR to 2019 Says a Research Report Available at ReportsnReports.com 2Global Laboratory Filtration Market To See 7.0% CAGR to 2019 Says a Research Report Available at ReportsnReports.com 3Global Laboratory Filtration Market To See 7.0% CAGR to 2019 Says a Research Report Available at ReportsnReports.com 4Global Laboratory Filtration Market To See 7.0% CAGR to 2019 Says a Research Report Available at ReportsnReports.com 5Surging Diabetic, Obese and Hypertensive Population Drives the Global Cholesterol Testing Market, According to New Report by Global Industry Analysts, Inc. 2Surging Diabetic, Obese and Hypertensive Population Drives the Global Cholesterol Testing Market, According to New Report by Global Industry Analysts, Inc. 3Surging Diabetic, Obese and Hypertensive Population Drives the Global Cholesterol Testing Market, According to New Report by Global Industry Analysts, Inc. 4CORD:USE is Pleased to Announce it has Partnered with Tianhe Stem Cell Biotechnologies, Developer of Cord Blood Stem Cell Therapy Showing Promising Results in Clinical Trials for the Treatment of Diabetes and Autoimmune Diseases 2CORD:USE is Pleased to Announce it has Partnered with Tianhe Stem Cell Biotechnologies, Developer of Cord Blood Stem Cell Therapy Showing Promising Results in Clinical Trials for the Treatment of Diabetes and Autoimmune Diseases 3CORD:USE is Pleased to Announce it has Partnered with Tianhe Stem Cell Biotechnologies, Developer of Cord Blood Stem Cell Therapy Showing Promising Results in Clinical Trials for the Treatment of Diabetes and Autoimmune Diseases 4FUNGITECT Consortium Adopts Genedata Selector as Data Analysis Platform for Anti-fungal R 2FUNGITECT Consortium Adopts Genedata Selector as Data Analysis Platform for Anti-fungal R 3
... HILLS, Mass., Sept. 22 Joseph F. Finn, Jr.,C.P.A. ... for,the benefit of creditors, announced today that all oral ... bid auction on October 10,2008., The three ... Delivery System 2. Biological Factors Affecting the Bioadhesion ...
... million received based on the positive review of interim ... EDMONTON, Sept. 22 /PRNewswire-FirstCall/ - BioMS Medical Corp. ... sclerosis (MS), today,announced that it has received the US$10 ... The milestone payment is based on the previously ...
... and Delivery Enable CyberKnife Centers ... Fulfill Increasing Demand for Radiosurgery, SUNNYVALE, Calif., Sept. ... leader in the field of radiosurgery,announced today that Oklahoma ... has dramatically reduced treatment,planning and delivery times over the ...
Cached Biology Technology:Spherics, Inc. Presented Three Key Technologies (BIOROD(TM), BIOGIT(TM), and SPHEROMER(TM)) at the 35th Annual Meeting of Controlled Release Society 2BioMS Medical announces receipt of milestone payment from Eli Lilly and Company 2Oklahoma CyberKnife Center Cuts Treatment Time in Half With Next Generation CyberKnife Technology 2Oklahoma CyberKnife Center Cuts Treatment Time in Half With Next Generation CyberKnife Technology 3Oklahoma CyberKnife Center Cuts Treatment Time in Half With Next Generation CyberKnife Technology 4
(Date:9/30/2014)... , Sept. 30, 2014  Spectra Automation, ... for the biotech and power generation industries, ... RECONN Bioprocess Manager, an easy-to-use and cost-effective ... towards bioprocess development laboratories. ... bioreactor and analyzer systems. Accessing and consolidating ...
(Date:9/30/2014)... KONG , Sept. 30, 2014 Winners of ... Economist Events, Innovation Summit scheduled to take place at the JW ... the summit, the award winners will share their experiences and the ... who have made a proven innovation over the past decade, will ... the night before the summit. It will be the first ...
(Date:9/29/2014)... September 29, 2014 -- Plants have a symbiotic ... the pants extract nutrients and defend against invaders ... contaminating fruits and vegetables. Now, scientist have discovered ... of seeds; thus ensuring that sprouting plants are ... University of Notre Dame, presented their findings today ...
Breaking Biology News(10 mins):Spectra Automation Introduces RECONN Bioprocess Manager 2Hear from The Economist's 2014 Innovation Award Winners at Innovation Summit on October 10th in Hong Kong 2Hear from The Economist's 2014 Innovation Award Winners at Innovation Summit on October 10th in Hong Kong 3Hear from The Economist's 2014 Innovation Award Winners at Innovation Summit on October 10th in Hong Kong 4Hear from The Economist's 2014 Innovation Award Winners at Innovation Summit on October 10th in Hong Kong 5Hear from The Economist's 2014 Innovation Award Winners at Innovation Summit on October 10th in Hong Kong 6Hear from The Economist's 2014 Innovation Award Winners at Innovation Summit on October 10th in Hong Kong 7Plants prepackage beneficial microbes in their seeds 2
... STOCKHOLM, Sweden: The last six years have seen significant ... food to children, with an increasing number of governments ... leading expert on the topic said today (Tuesday). ... Tim Lobstein presented an analysis of the European policy ...
... University effort to develop aviation bio-fuel is underway with ... Aviation Fuels Northwest" project; the first of its kind ... Boeing, the Port of Seattle, The Port of Portland, ... biomass options within a four-state region as possible sources ...
... patients may soon have the option of custom-made ... thanks to researchers at the University of Illinois ... Whether resulting from illness or injury, loss of ... cosmetic implications: The patient,s chewing, swallowing, speaking or ...
Cached Biology News:Progress made in addressing food marketing to children, but challenges remain 2Progress made in addressing food marketing to children, but challenges remain 3Progress made in addressing food marketing to children, but challenges remain 4First of its kind: WSU led Bio-Jet fuel project officially gets off the ground 2Engineering could give reconstructive surgery a facelift 2