This story has been updated to include comments from a company official.
Astra Biotech will later this year launch a microarray-based test for the detection of 25 of the most common mutations causing cystic fibrosis in pan-European populations, the firm said this week.
The test is one of a number of array-based diagnostics the Luckenwalde, Germany-based company has in development, according to a company official.
Alexandra Ghica-Cantacuzino, international sales and marketing manager at Astra Biotech, told BioArray News this week that the company expects to secure a CE-IVD Mark for the test in the third or fourth quarter of this year and that it will offer it directly and through distributors in Europe.
Astra Biotech is the manufacturer of the new CF assay, Ghica-Cantacuzino said. She added that the company, which has traditionally sold reagents and diagnostic kits for detecting human hormones, genetic diseases, tumor markers, and allergens, is now planning to offer a suite of array-based tests. Ghica-Cantacuzino, however, declined to describe the other assays in development.
Founded in 2009, Astra Biotech is based in a biocluster about 30 miles (50 km) from Berlin. The privately held firm's technology platforms include enzyme-linked immunosorbant assays, PCR, and now arrays.
Astra Biotech is positioning its platform ahead of launch as being more informative than existing CF tests. The Cystic Fibrosis Foundation lists blood and sweat tests as the most common methods for detecting CF in newborns, but Astra Biotech argues that both methods can lead to both false positive and false negative results.
"For example, carriers of a single mutated copy of the relevant cystic fibrosis transmembrane conductance regulator gene, who will not develop the disease, may test positive; while individuals with mild mutations in both copies of the CFTR gene, who will develop CF, may have a near-normal sweat test," the company said in a statement.
Astra Biotech's test contains the "most common mutations identified as leading to CF disease in Western European populations, together with nine mutations most frequently found in Eastern European ethnic groups," the company said.
Applications for the diagnostic include CF newborn screening, prenatal diagnostics, CF carrier testing, and testing of couples with a personal or close family history of CF as recommended by the World Health Organization, the firm added.
Ghica-Cantacuzino said that the company is mulling expansions of the test to include mutations relevant to other populations. "For example, if there is a mutation that is found in Middle Eastern populations, we could consider adding or changing content on the array," she said.
Astra Biotech is currently focused mainly on the European market, though Ghica-Cantacuzino said the firm is exploring opportunities in the Middle East and Asia. She said that the test could become available in the US, but only for research use.
Having a test cleared for clinical use by the US Food and Drug Administration requires "deep pockets," she noted.
A number of other firms offer array-based CF tests in various markets. Pasadena, Calif.-based GenMark Diagnostics sells its US Food and Drug Administration-cleared eSensor Cystic Fibrosis Genotyping Test for use on its eSensor XT-8 platform.
Gamidor Diagnostics, part of the Gamida for Life group, also offers a CF screening test on its array-based platform in Israel. Gamida for life acquired the platform, originally developed by San Diego-based Nanogen, last year (BAN 2/2/2010).