Astra Biotech is in the pre-launch phase of its microarray-on-a-chip test, developed to detect 25 of the most common mutations causing cystic fibrosis (CF) in pan-European populations.
Cystic fibrosis is a recessive genetic disease that causes severe malfunctioning of the exocrine glands, respiratory system and gastrointestinal tract.
Currently, cystic fibrosis is routinely diagnosed by newborn screening using a blood test and sweat test - although these can lead to both false positive and false negative results.
Astra Biotech said it has developed a platform that provides a more reliable cystic fibrosis diagnosis, based on best practice guidelines for molecular genetic diagnosis of cystic fibrosis and cystic fibrosis transmembrane conductance regulator (CFTR)-related disorders.
Using microarray technology and a microchip designed according to the newest clinical genetic data, the Astra Biotech test is said to enable rapid simultaneous detection of a panel of 25 mutations in the CFTR gene.
These include the most common mutations identified as leading to cystic fibrosis disease in western European populations, together with nine mutations most frequently found in eastern European ethnic groups.
Astra Biotech said the cystic fibrosis microarray test ensures reliable detection with high specificity and sensitivity.
Applications include: cystic fibrosis newborn screening; prenatal diagnostics; carrier testing; and testing of couples with a personal or close family history of cystic fibrosis.
