FCMB is developing a suite of non-invasive prenatal diagnostics based on isolating fetal cells from maternal blood samples. FCMB’s diagnostics have the potential to provide results that are as accurate as more invasive procedures, such as amniocentesis and chronic villus sampling (CVS), without the risk of miscarriage or other fetal damage.
The scientific community has known for many decades that fetal cells circulating in maternal blood could be utilized to diagnose genetic abnormalities. However, isolating these cells is difficult given their extreme scarcity. Taking a novel approach to this problem, FCMB has developed a proprietary technology that allows for the collection and preservation of fetal cells from maternal blood samples. These cells can be subsequently analyzed using standard molecular biology procedures to determine genetic abnormalities in a non-invasive fashion.
“We are quite excited about the about the opportunity ahead of us in prenatal testing,” says Dr. Andreas Eckelt, Chief Executive Officer of FCMB. “We believe that our technology has the potential to significantly improve the standard of care, while providing meaningful cost advantages to the healthcare system.”
Under current guidelines, parents of unborn children and the medical community face a dilemma when it comes to prenatal testing. Non-invasive diagnostic techniques, such as ultrasound or maternal serum sampling, can only provide risk stratification, as they lack specificity and can identify only predominant genetic aberrations. Invasive techniques, such as amniocentesis or CVS, provide conclusive results, but also carry a 1-2 per cent risk of miscarriage. Because of this risk, invasive testing is currently limited to approximately 5 per cent of pregnant women.
“Given the unmet need in the multi-billion dollar market for prenatal diagnostics, there is a race to commercialize new technologies,” says Frost & Sullivan Senior Research Analyst, Arun.A.K. “While FCMB’s technology has yet to be commercialized, we believe that it has the potential to offer substantial accuracy advantages over other non-invasive techniques, as well as significant safety advantages over more invasive procedures.”
FCMB intends to offer its diagnostic testing using a service-based model. FCMB believes that the accuracy and risk profile of its diagnostics, combined with competitive pricing and the relative simplicity of a blood draw, will result in rapid adoption by the medical community. FCMB’s first test is for Down’s syndrome (Trisomy 21), which occurs in approximately one in 800 births and is characterized by lifelong intellectual and developmental disabilities. FCMB also has plans to expand its product offering to other genetic abnormalities such as Edward’s syndrome (Trisomy 18), Patau syndrome (Trisomy 13) and Klinefelter syndrome.
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About FCMB ApS
FCMB was founded in 2005 with the vision of developing the first non-invasive prenatal diagnostics technology platform based on the capture of fetal cells in maternal circulation. FCMB has raised venture funding from Inventure Capital and Oestjvsk Innovation. FCMB has 15 employees and is based in Vejle, Denmark.
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