Three months after launching its non-invasive prenatal test for trisomy 21 in German-speaking countries, LifeCodexx has accepted approximately 1,000 samples and is considering expanding the test to other European countries.
In August, the company released its PrenaTest, the first non-invasive fetal aneuploidy sequencing test available in Europe. Initially, 70 prenatal clinical and hospitals in Germany, Austria, Switzerland, and Liechtenstein were offering the test. That number has now more than doubled to about 150 prenatal practices and clinics, the company said last week.
LifeCodexx licensed technology for the test from Sequenom last year under a five-year agreement, initially to offer trisomy 21 and related testing in German-speaking countries but potentially also in other nations (CSN 8/17/2012).
As of last week, the company had analyzed about 900 samples from women at risk for fetal trisomy 21. While most of these came from Germany, Austria, and Switzerland, a number of women originated from the Netherlands, Italy, France and the UK, as well as from Eastern Europe and the Middle East, according to Elke Decker, LifeCodexx's director of strategic marketing, communication and business administration.
Several private health insurance companies in Germany have already reimbursed the cost of the test, currently €1,250 ($1,600). While many women insured through Germany's non-profit health insurance system, which covers about 85 percent of the population, are also trying to get reimbursed, LifeCodexx is not aware of any successful cases so far.
Of the tests performed, 97 percent were negative for fetal trisomy 21, 1.5 percent were positive, and 1.5 percent could initially not be reported, mainly because of insufficient amounts of cell-free fetal DNA in the mother's blood. A failed test is repeated if the patient agrees, Decker noted.
"As far as known," women had positive tests results confirmed by amniocentesis, according to the company, as recommended by the German association of practicing prenatal medicine specialists, the German Society of Human Genetics, and the International Society for Prenatal Diagnosis.
LifeCodexx has already reduced the turnaround time for the test, which was initially close to three weeks, to two week or 10 business days.
It also plans to expand the test to trisomies 13 and 18 "very soon," Decker said. Development for these indications is already complete and the company is currently awaiting regulatory approval.
LifeCodexx is also evaluating whether to expand its test to other countries in the European Union. Decker declined to comment at this time which countries the firm is considering.
It will likely face competition in Europe in the future, though. For example, BGI said last month that is has partnered with a genetics, fetal medicine and assisted reproduction center in Prague to offer non-invasive fetal trisomy testing in the Czech and Slovak Republics (GWDN 10/16/2012).