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A simple new test
predicts pregnancy complications
This year, Diagnostic Technologies (DTL), based in Yokneam Illit,
proved that with the right idea, even a young start-up can lead an important
consortium in the European R&D Framework..
In November 2005, DTL submitted a grant application to the EU 6th
R&D framework of life sciences and healthcare program. The application
aims to screen early in pregnancy women who are at risk to develop
preeclampsia, a pregnancy disorder associated with pregnancy induced
hypertension and damage to the kidney, liver or the brain of the mother. In
addition, the application included a plan to tailor medications for women
identified as being at risk to develop preeclampsia. The company assembled
a consortium of European partners, which earned the outstanding project
prize honor in lifesciences and healthcare for 2006.
Consortium members include PerkinElmer of Finland, which holds
world distribution rights to the preeclampsia diagnostic kits developed by
DTL; the company’s Portuguese distributor of preeclampsia diagnosis ,
and the European leaders in preeclampsia research, who are the company
partners in the clinical trials in Austria, Hungary, England, Italy and
Switzerland. These partners are world leaders in the field, including
Professor Kypros Nicolaides of England, a pioneer in first trimester
prenatal diagnostics.
The proposal submitted to the European Framework Project was
scored very high obtaining a score of 28.5 out of 30, and received the
full funding requested - 2.3 million euros. The three-year project has
three main goals:
1. Improving the efficacy of first trimester prediction of the risk for a later
development of preeclampsia based on blood tests and the determination
of placenta protein 13 (PP13), a biomarker developed by DTL to predict
the risk for preeclampsia.
2. Examining the efficacy of longitudinally repeated blood tests of
preeclampsia biomarkers coupled with monitoring the efficacy of antipreeclampsia
drugs and food supplements currently in use; and
3. Developing new products to advance diagnosis and treatment for
women at high risk for preeclampsia.
Genetic treasure
Behind the award-winning proposal is the basic research conducted
in Israel, which led to the scientific breakthrough by researchers at the
Technion-Israel Institute of Technology in Haifa. In the early 1990s,
Technion scientists sought an efficient way to conduct genetic tests, and
focused their efforts on the placenta, whose characteristics make it the
perfect tissue for conducting genetic studies. They discovered approximately
56 specific proteins and genes related to processes regulating pregnancy
development or pathology. Among the proteins they had identified and
isolated was Placental Protein 13, or PP13, a protein that was discovered
to be associated with the development of preeclampsia. The Technion
researchers discovered that the level of this protein is abnormal in women
who will go on to develop preeclampsia. In 1994, DTL was founded to
explore commercial applications for this discovery. In the early years,
the company was based in the Technion’s laboratories.
After fine-tuning its technology, DTL left the Technion in 2001 and
developed a simple method for the determination of the protein in blood
samples of pregnant women. It quickly became clear that the test enabled
to predict in the first trimester with a very high degree of certainty woman’s
risk of developing preeclampsia in the third trimester. DTL’s registered
patents are on the protein and genetic sequence of PP13, on monoclonal
antibodies to detect its level and on kits to screen women at risk for
preeclampsia. The patents covered a number of parameters which made
it especially strong in the field of modern biotechnology, protecting the
intellectual properties that are the cornerstone of DTL’s activities.
One in five pregnancies is at risk
There is a considerable potential market: Infertility affects approximately
20% of couples in the western world, and about 20% of pregnancies are
at risk. Among the worst complications is preeclampsia, a pregnancy
disorder that is associated with sudden hypertension, a damage to the
kidney, the liver and the vascular system, which can exuberate to brain
convulsion and stroke. When women develop the severe disorder delivery
is initiated, and the newborn are often delivered prematurely and suffer
from motor and cognitive disorders and blindness. Women who suffered
from preeclampsia are at higher risk for developing cardiovascular ailments
later in life. Preeclampsia affects 5-7% of all pregnant women and is
responsible for 18% of maternal deaths during pregnancy, and about
one third of pre-term deliveries. The treatment of women and newborns
suffering from complications of preeclampsia as estimated by the US
Department of Human Health is approximately $30 billion annually.
“Even though the World Health Organization has determined that
preeclampsia is the second most common cause of death among
pregnant women, to this day, no simple test has been found to predict
its development.”
DTL’s business model is based on providing solutions to the growing
pre-natal diagnostics industry. A growing proportion of women in the
western world undergo numerous prenatal tests to ensure the success of
the pregnancy. The company goal is to provide means and tools that will
enable every pregnant woman to undergo a simple, quick and inexpensive
screening test during the earliest stages of her pregnancy to reveal her level
of risk for developing preeclampsia. If a woman is defined as belonging
to the high-risk group, the next goal is to create a system of surveillance
that will follow the progress of her pregnancy, via repeated tests and
examine the efficacy of preventive treatment. The PP13 test is positioned
to assess the development of the illness and its stages and to indicate if
a treatment has been effective in preventing preeclampsia.
At present, the company’s main shareholder is the Haifa-based Teuza
Venture Capital Fund and the company chairman, Giora Meyuhas. Other
investors include the Technion, Venture funds from the US and from
England, Mr. Ken Abramowitz, the founder of NGN Capital - the largest
US healthcare VC and private investors. DTL has raised over $4 million
to date, of which $800,000 were grants provided by the Chief Scientist