US-based CSL Behring has announced the availability of DNA1 Advanced Alpha-1 Screening (DNA1), a new test kit designed to improve diagnosis of Alpha-1 antitrypsin deficiency (Alpha-1).
Alpha-1 is a serious hereditary condition that is often misdiagnosed as chronic obstructive pulmonary disease or asthma. Alpha-1 can cause lung disease and/or liver disease.
CSL Behring claims that 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.
US-based Biocerna has developed the DNA1 Advanced Alpha-1 Screening and laboratory testing of the kits is provided by the company.
DNA1 offers test results for clinical chemistry, targeted genotyping, next generation sequencing and isoelectric focus.
Clinical chemistry involves 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 involves sequencing of the SERPINA1 gene to identify unknown variants.
Isoelectric focus is results compared to genetic results as a confirmatory step.
CSL Behring North America commercial operations senior vice president Lynne Powell noted the company is dedicated to the healthcare communities that it serves.
"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," Powell added.
DNA1 is launched during Alpha-1 Awareness Month.