CSL Behring Launches Innovative Test Kit Designed to Improve Diagnosis of Alpha-1

Alpha-1 is a Serious Medical Condition That Is Often Misdiagnosed as COPD or Asthma

Nov 25, 2013, 10:07 ET from CSL Behring

KING OF PRUSSIA, Pa., Nov. 25, 2013 /PRNewswire/ -- CSL Behring today announced the availability of DNA1 Advanced Alpha-1 ScreeningTM (DNA1), a new test that aims to improve diagnosis of Alpha-1 Antitrypsin Deficiency (Alpha-1). Launched during Alpha-1 Awareness Month, DNA1 is the only comprehensive Alpha-1 test available that identifies known and unknown clinically relevant genetic variants to help physicians achieve an accurate diagnosis.

Alpha-1 is a serious hereditary condition that can cause lung disease and/or liver disease. It is often misdiagnosed as COPD, asthma or emphysema because the symptoms are similar: shortness of breath, chronic cough, difficulty breathing, and wheezing.1 On average, people with Alpha-1 will see three doctors over seven years before they are accurately diagnosed.2 During that time, lung damage progresses. The American Thoracic Society and European Respiratory Society recommend screening adults with COPD, emphysema, or irreversible asthma for Alpha-1–associated emphysema.

"Early diagnosis and treatment of Alpha-1 is important to help prevent irreversible lung and/or liver damage," said Friedrich Kueppers, M.D., Professor of Medicine at Temple University School of Medicine. "CSL Behring's DNA1 test allows physicians to quickly and efficiently diagnose those with Alpha-1. The test also identifies other genetic mutations that may lead to Alpha-1 related emphysema that current testing technology might be missing."

DNA1 Advanced Alpha-1 Screening was developed by Biocerna LLC and laboratory testing of the kits is provided by the company. DNA1 offers test results for the following:

  • Clinical chemistry – Blood spot assay to test patient alpha-1 antitrypsin (AAT) levels, as well as a C-reactive protein (CRP) test to provide full clinical analysis
  • Targeted genotyping – Identifies all known, clinically relevant variants, including S, Z, and F
  • Next generation sequencing – Sequencing of the SERPINA1 gene to identify unknown variants
  • Isoelectric focus – Results compared to genetic results as a confirmatory step    

"For the 100,000 Americans who are estimated to be living with Alpha-1, a healthy and fulfilling lifestyle can be maintained with the proper treatment," said John Walsh, President and CEO of the Alpha-1 Foundation. "The first step is taking a simple test, such as DNA1, to ensure an accurate diagnosis for all Alpha-1 deficient patients. Once diagnosed, an appropriate treatment plan can be developed."

"CSL Behring is dedicated to the healthcare communities that we serve," said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring. "This dedication includes improving the ways in which rare and/or serious diseases, such as Alpha-1, are tested and diagnosed. We are proud to offer an advanced Alpha-1 screening test for the estimated 90 percent of patients who are living with Alpha-1 but have not been properly diagnosed."

To order a DNA1 Advanced Alpha-1 Screening test kit, please call toll-free 1-888-508-6978. The test must be administered by a healthcare professional.  

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.

CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.

Media Contact:
Greg Healy
Senior Manager, Public Relations & Communications
CSL Behring

1 Alpha-1 Foundation -- What is Alpha1? Alpha1 Fast Facts. Available at: http://www.alpha-1foundation.org/alphas/?c=01-What-is-Alpha-1-Alphas. Accessed on November 11, 2013.

2 COPD International Network-You Are Not Alone. Available at http://www.copdinternational.com/Library/alpha-1.htm. Accessed on November 11, 2013.