TIDMAGL
RNS Number : 3962F
Angle PLC
29 October 2018
For immediate release 29 October 2018
ANGLE plc ("the Company")
PARSORTIX DEMONSTRATES CAPABILITY TO HARVEST FETAL CELLS FROM
THE BLOOD OF PREGNANT WOMEN FOR NON-INVASIVE PRENATAL TESTING
(NIPT)
Parsortix system offers potential to greatly extend current NIPT
applicability to a wide range of conditions not currently feasible
with existing techniques
Commercialisation discussions initiated with corporate
partners
Results presented at 6th Annual Advances in Prenatal Diagnostics
conference
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce positive results from a pilot
study to investigate the potential of ANGLE's Parsortix(TM) system
to harvest fetal cells from the peripheral blood of pregnant women
for the detection of fetal abnormalities. The results are being
presented today at the 6(th) Annual Advances in Prenatal
Diagnostics conference in Cambridge, Massachusetts.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"Non-invasive prenatal testing is a major new market for the
Parsortix system and a potential solution to the current
limitations of NIPT, providing a more comprehensive diagnosis of
fetal abnormalities for mothers at risk of an affected pregnancy.
ANGLE's product-based approach to liquid biopsy enables us to
leverage partnerships with third parties, which we are developing
in the NIPT space, an established and fast growing large scale
market."
In recent years, NIPT, based on a simple blood test for the
mother, has emerged as the preferred method of testing prenatal
fetal health in place of the traditional invasive chorionic villi
sampling (CVS) and amniocentesis procedures. Over the next year,
the NHS plans to roll out NIPT to women identified as having a high
risk of an affected pregnancy.
However, current NIPT has two key limitations. First and
foremost, NIPT is currently based on analysis of cell-free fetal
DNA (fragments of dead fetal cells) which is limited to testing for
chromosomal disorders that are caused by the presence of an extra
or missing copy (aneuploidy) of a chromosome. These include trisomy
21 (Down's syndrome) and a small number of other very rare
conditions. The second limitation is a barrier to entry for
companies offering NIPT as current methods are based on next
generation sequencing analysis of cell-free DNA and the
intellectual property is tightly held by a few large
corporates.
Both of these limitations can be addressed if intact fetal cells
(as opposed to tiny fragments of dead fetal cells) can be reliably
harvested from the blood of pregnant women. An intact fetal cell
opens the potential for whole genome analysis of the cell providing
complete information on numerous genetic conditions and not just
limited to a very small number of conditions. ANGLE owns granted
intellectual property in relation to the Parsortix system, which
covers fetal cells as well as cancer cells. Parsortix analysis is
based on intact fetal cells not cell-free DNA and hence does not
infringe the patents held by other corporates in relation to
cell-free DNA analysis.
Following an approach from a company in the NIPT space, ANGLE
undertook a pilot study of the capability of the current version of
the Parsortix system to harvest and then analyse fetal cells from
the blood of pregnant women.
ANGLE's study analysed the blood of 19 pregnant women processed
through the Parsortix system. Large , putative fetal cells were
identified in every case. No such cells were found in a similar
number of control cases of women who were not pregnant. A test for
XY chromosomes was performed whereby if the cells were from a male
fetus an XY result would be expected. In 8 out of 19 cases (42%),
XY was detected, in line with the expectation that around half of
the pregnancies would be of a male child.
One blood sample was drawn from a pregnant woman diagnosed with
a Down's syndrome fetus (trisomy 21). In this case, the fetal cells
captured by the Parsortix system were found to be positive for
trisomy 21. This confirmed the potential to analyse the captured
fetal cells for key diagnostic information.
This was a small-scale pilot study and, whilst highly
encouraging, substantial further work will be necessary to develop
an effective NIPT test. It is estimated that current cell-free
fetal DNA NIPT techniques identify less than 10% of all serious
birth defects. A test utilising intact fetal cells could have much
wider application than the current cell-free tests. Key conditions
which were previously investigated by CVS or amniocentesis but
which are not addressed by cell-free fetal DNA include: Fragile X,
muscular dystrophy, sickle cell disease, spina bifida, thalassaemia
and numerous other rare, inherited disorders. Use of Parsortix to
capture and evaluate intact fetal cells has the potential to
greatly widen the applicability of NIPT, enabling other conditions
such as those listed above to be diagnosed using a simple blood
test.
The size of the NIPT market based on its current limited medical
applicability was estimated to be c. US$600 million in 2016 and is
forecast to rise to in excess of US$1.0 billion per annum by 2022.
The overall size of the NIPT market continues to grow as the
traditional invasive procedures have been limited to high risk
pregnancies whereas a blood test can be more widely deployed and
include low risk pregnancies. The wider medical information
available from an intact fetal cell could be expected to further
grow the market substantially.
ANGLE is in discussions with interested parties with a view to
securing one or more corporate partners for NIPT commercialisation
so as not to divert existing resources from our key established
cancer projects.
For further information ANGLE:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks, Max Bullen-Smith
ECM - Alice Lane +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig,
Chris Lee +44 (0) 203 705 9330
FTI Consulting
Simon Conway, Mo Noonan, Stephanie Cuthbert +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 212 850 5612
For Frequently Used Terms, please see the Company's website on
http://www.angleplc.com/the-parsortix-system/glossary/
This announcement contains inside information.
Notes for editors
About ANGLE plc www.angleplc.com
ANGLE is a world leading liquid biopsy company with sample to
answer solutions. ANGLE's proven patent protected platforms include
an epitope-independent circulating tumor cell (CTC) harvesting
technology and a downstream analysis system for cost effective,
highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix(TM)
system and it enables a liquid biopsy (simple blood test) to be
used to provide the cells of interest. Parsortix is the subject of
granted patents in Europe, the United States, Canada, India, China,
Japan and Australia and three extensive families of patents are
being progressed worldwide. The system is based on a microfluidic
device that captures live cells based on a combination of their
size and compressibility. The Parsortix system has a CE Mark in
Europe for the indicated use and FDA clearance is in process for
the United States.
ANGLE's analysis technology for proteins and nucleic acids of
all types is called Ziplex(R) and is based on a patented flow
through array technology. It provides for low cost, highly
multiplexed, rapid and sensitive capture of targets from a wide
variety of sample types. A proprietary chemistry approach allows
for the capture and amplification of over 100 biomarkers
simultaneously in a single reaction. The Ziplex system is ideal for
measuring gene expression and other markers directly from Parsortix
harvests.
ANGLE's proprietary technologies can be combined to provide
automated, sample to answer results in both centralised laboratory
and point of use cartridge formats.
Furthermore, ANGLE has established formal collaborations with
world-class cancer centres. These Key Opinion Leaders are working
to identify applications with medical utility (clear benefit to
patients), and to secure clinical data that demonstrates that
utility in patient studies. Details are available here
http://www.angleplc.com/the-company/collaborators/
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END
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