PARSORTIX DEMONSTRATES CAPABILITY TO HARVEST FETAL CELLS FROM THE BLOOD OF PREGNANT WOMEN FOR NON-INVASIVE PRENATAL TESTING (NIPT)

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 ParsortixTM 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 6th 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.   

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 ParsortixTM 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® 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 herehttp://www.angleplc.com/the-company/collaborators/

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