After seven years of incubation in the academic environment, in 2001
Diagnostic Technologies made a strategic decision to employ Dr.
Hamutal Meiri to run the company. Dr. Meiri had earned a PhD. in
Neurophysiology to which she added an MBA. Her academic work was
topflight and her name appears on 30 peer reviewed scientific papers.
She has also received numerous professional prizes. There was a
question mark however, since she had no commercial experience.
However, that strategic decision has paid handsome dividends. She
contributed to the company's Intellectual Property (IP) and her name
appears among the patent holders. However, her main contribution was
to convert the IP into a marketable product which is currently
entering European markets.
Diagnostic Technologies (DTL) fills a market vacuum by providing a
novel diagnostic tool to aid in the assessment of high risk and
problem pregnancies.
It has developed novel devices for monitoring pregnancy-at-risk based
on emerging genomics and proteomic research. Combined with home
monitoring, DTL's diagnostics can be readily packaged into a
treatment plan for pregnant women who are at risk for pregnancy
complications. DTL discovered the gene for placenta protein 13
(PP13). Using a simple blood test, DTL developed specific antibodies
to detect PP13 in the pregnant mother's serum, a new test to
diagnose mothers at risk for preeclampsia (PE), high blood pressure,
intrauterine growth retardation (IUGR) and pre-term delivery (PTD).
Preeclampsia is a condition that kills hundreds of mothers-to-be each
year in the United States as well as many thousands throughout the
world. The condition leads to 15 per cent of all premature births,
researchers say.
Pre-eclampsia occurs in as many as eight per cent of U.S.
pregnancies, often striking healthy women without warning, and can
lead to seizures, strokes and kidney damage. The cause is unknown,
and there is no reliable way in use today to predict who will develop
it. The only known cure is to deliver the baby, often prematurely. In
cloning the PP13 gene, DTL found it to be a placental specific enzyme
(phospholipase A) produced during pregnancy in the placenta and
released into the maternal blood stream. PP-13 release during the
normal course of pregnancy is low as the placenta differentiates in
the 1st and 2nd trimester, followed by a steep increase occurring at
the third trimester, when the placenta triples its size. Blood tests
of patients with PE and IUGR correlate with PP-13 deficiency in the
1st trimester and its steep slope of early increase between the first
and the second trimester. The protein level and its slope of change
are used as the parameters incorporated into the risk algorithm to
detect at least 90% of all cases with 70-100% higher risk as
compared to normal at 2-3% false positive rate.
No reliable blood serum biomarker or testing kit exists to screen
for pregnancy complications. Existing imaging methods (Doppler
ultrasound) provide confirmatory results for PP-13 as the serum
marker. There are no interventional methods capable of detecting
these complications. Other blood or urine testing detects the
pregnancy disorders at a stage when clinical symptoms are already
apparent and requires delivering the baby since the mother and baby
are already at appreciable risk.
"The technology works to a degree of confidence that it has the
ability to change the way OBGYN and general practitioners think about
delivering medical services to pregnant mothers in the 1st, 2nd and
3rd trimesters of gestation," says Dr. Meiri.
DTL has distribution agreements in a couple of European countries
with local distributors. Recently the company obtained letters of
intent for international distribution by two of the leading
international corporate concerns . An American company requested to
distribute the product to specialized fertility clinics in the US.
The company is confident that after the FDA approval, based on
studies carried on in the NIH prenatal lab, it will obtain
reimbursement approval for its kit the by the US Medicare and
Medicaid.
The company's current financing round, aimed to raise $5.0m. is to
accelerate its market entry by completing clinical trials and to fund
marketing costs.
"In 2007 we are hoping to reach sales of $4.0 M. and then look
forward to exponential growth. Our goal is to reach a 10% market
share by 2010," says Giora Meyuhas, the company's chairman, a
chemical engineer, who had served as Israel's Economic Minister to
North America.
Israel has a well earned reputation in the field of diagnostics, an
area of activity that relies on ingenuity. However, the distance from
the laboratory to the market place is not the identical for all
companies.