BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Phadia US Inc. Receives FDA 510 (K) Clearance for Four New Autoimmune Assays


6/24/2010 3:43:43 PM

PORTAGE, Mich.--(BUSINESS WIRE)--Today Phadia announced that it has received FDA 510 (K) clearance for four new EliA autoimmune antibody assays. These new assays will provide physicians with additional tools needed to aid in the diagnosis of Antiphospholipid Syndrome (APS). The newly available EliA assays, anti-cardiolipin (aCL) IgG/IgM and anti-B2-glycoprotein 1 (anti-B2-GP1) IgG/IgM, have proven to be essential, sensitive, and specific markers to aid in the diagnosis of APS.

Antiphospholipid syndrome is a disorder of coagulation that causes thrombosis (blood clots) in both arteries and veins. The syndrome can affect any organ system and is a common cause of pregnancy related complications such as miscarriage, stillbirth, preterm delivery, or severe preeclampsia. The most common venous event is deep vein thrombosis of the lower extremities (blood clot of the deep veins of the legs), and the most common arterial event is stroke. In some cases, APS seems to be the leading cause of mental and/or development retardation in the newborn. The syndrome occurs due to an autoimmune reaction and production of antibodies against phospholipid (aPL), a normally beneficial cell membrane substance.

Autoimmune diseases impact an estimated 46 million patients per year in North America. These diseases pose a significant diagnostic challenge for clinicians. Antiphospholipid syndrome is complex and represents a common autoimmune diagnostic challenge. These four new EliA assays, when used together, represent the first and only fully automated diagnostic tests that can be utilized to aid in the accurate diagnosis of APS.

Gabi Gross, Autoimmune Franchise Leader of Phadia US, says, “Since its inception in 1967, Phadia has set the standard in the detection and diagnosis of allergies. Now, with the introduction of the EliA autoimmune product line in the United States, we are providing laboratories and clinicians with the same standard providing diagnostic tools with high performance assays to support the diagnosis of autoimmune diseases such as antiphospholipid syndrome.”

The clearances announced today extend Phadia’s product line of CLIA Moderately Complex assays in the EliA autoimmune product line. Other commercially-available EliA assays include Cyclic Citrullinated Peptide (CCP), tissue Transglutaminase (tTG) IgA and IgG (Celikey®), Gliadin IgA and IgG, dsDNA, Extractable Antinuclear Antibody (Symphony), and ENA antibodies to the following antigens: Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP and Jo-1.

The EliA assays are available on the Phadia Laboratory Systems Phadia® 100? and Phadia 250 and feature a quick turnaround time, are performed under master curves with monthly calibration, have on board instrument dilution capability, and are performed using a discrete, single well, random access, non-microtiter plate format.

About Phadia

Phadia is setting the standard as the global leader in allergy and autoimmune blood testing. The ImmunoCAP® Specific IgE blood test delivers Results You Can Trust. The accuracy, precision and clinical utility of ImmunoCAP is supported in over 3,000 peer-reviewed publications. EliA autoimmune assays represent Excellence in Autoimmunity. The fully automated, cutting edge Phadia Laboratory System technology platforms offer walk away convenience. Learn more about the EliA autoimmune assays as well as why the ImmunoCAP Specific IgE blood test is the worldwide leader for serologic, specific IgE testing by visiting www.phadia.us.

Contacts Gregory FCA Communications Joseph Crivelli 610-228-2100 (office)



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES