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Estonia's Asper Biotech Gains CLIA Compliance to Reach US Clinical Market


From its office in Tartu, Estonia, Asper Biotech continues to introduce new microarray-based tests related to reproductive health, oncology, and opthamalogy.

The 14-year-old company has always marketed its genotyping services under a research label, but that changed last month when Asper gained US Clinical Laboratory Improvement Amendment certification for its medical laboratory.

With the CLIA certification, "the genetic tests that we have offered previously for research use only can now be offered to doctors, too," Valdur Mikita, Asper's head of sales, told BioArray News this week.

Asper's core technology is called arrayed primer extension, or APEX. It involves hybridizing probes arrayed on slides and performing a primer extension reaction in which DNA polymerase extends the hybridized primers by adding a base that is complementary to the nucleotide of interest. The incorporated bases are then detected and alleles determined.

Relying on APEX, Asper has made dozens of genotyping assays available via its services lab. Its menu includes tests for reproduction-related and prenatal conditions, such as cystic fibrosis and Noonan syndrome; for various ocular disorders such as age-related macular degeneration and corneal dystrophy; and for tumor-related conditions and predispositions, such as ovarian and breast cancers.

Two years ago, Asper also introduced array-based prenatal testing for fetuses with increased nuchal translucency but normal karyotype (BAN 9/13/2011). Nuchal translucency is a collection of fluid under the skin at the back of a fetus' neck that can be measured using ultrasound during the first trimester of pregnancy, and is associated with several chromosomal abnormalities.

The nuchal translucency panel was developed with Northwestern Reproductive Genetics, a Chicago-based cytogenetics laboratory.

According to Mikita, some of Asper's US customers include researchers at Columbia University and the University of Pennsylvania. Other international clients are based at Nijmegen Radboud University in the Netherlands, Lund University in Sweden, and Ulm University and Regensburg University in Germany. In total, he said the company has performed analyses for clients from 45 countries.

Mikita said that it is too soon to gauge whether the new CLIA certification has had an impact on the firm's business, as it achieved compliance last month. He noted that Asper has many scientific clients in the US, and that the company hopes to reach clinicians with their assistance.