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NIPD Genetics Raises €2.5M to Fund Development of Noninvasive Down Syndrome Dx

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NIPD Genetics, an early-stage Cypriot molecular diagnostics firm, said last week that it has raised €2.5 million (about $3.36 million) and moved into a new facility to support the planned commercialization of its noninvasive prenatal diagnostic test for Down syndrome.

The company, an October 2010 spinoff of the non-profit Cyprus Institute of Neurology and Genetics, developed its test based on the research of CING scientist Philippos Patsalis.

The test combines a technique called methylated DNA immunoprecipitation, or MeDiP, with qRT-PCR. More specifically, MeDiP uses an antibody specific for 5-methylcytidine to capture methylated sites and enrich for hypermethylated fetal and hypomethylated maternal DNA regions.

Following methylation enrichment of the fetal DNA in maternal circulation, the researchers apply qRT-PCR to quantify the amount of fetal DNA in the test sample. By comparing the amount of fetal DNA present in an unknown sample to that of a control sample from a pregnant woman with a normal fetus, the technique can quantify the extra copy of chromosome 21 and distinguish Down syndrome pregnancies from normal pregnancies.

In March, Patsalis and colleagues published a paper in Nature Medicine demonstrating that the assay can diagnose Down syndrome with 100 percent sensitivity and specificity. They also provided preliminary evidence that their method is simpler, faster, and cheaper than other noninvasive methods for diagnosing the condition (PCR Insider, 3/10/11).

At the time, Patsalis told PCR Insider that NIPD Genetics hoped to commercialize its test within two years. Last week, the company disclosed that it successfully raised €2.5 million from both listed and privately held funds as well as private investors.

The company said that it plans to use these proceeds to fund continued research and development and subsequent international commercialization of the Down syndrome test as well as other noninvasive tests for genetic disorders, though it didn't specify which ones.

Also, NIPD said that in July it appointed a new board of directors; and at the start of this month it has moved to new premises in Cyprus with specialized laboratories, administrative offices, and production facilities.

NIPD has also filed a provisional patent application with the US Patent and Trademark Office for its method and test.

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