TIDMAGL
RNS Number : 8335I
Angle PLC
26 March 2018
26 March 2018
ANGLE plc ("the Company")
ANGLE'S OVARIAN CANCER RISK ASSESSMENT ACHIEVES THE HIGHEST
SENSITIVITY AND SPECIFICITY FOR PREDICTING CANCER
Detailed results of 200 patient study presented at the world's
leading gynecologic oncology conference
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce that detailed results from its US
pelvic mass study (ANG-003) have been presented at The Society of
Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in New
Orleans. The results follow the publication of headline data from
the ANG-003 study on 4 July 2017.
Dr Richard Moore, Director of the Gynecologic Oncology Division,
University of Rochester Medical Center Wilmot Cancer Institute
presented results from the 200 patient prospective study examining
the use of ANGLE's Pelvic Mass Triage (PMT) test in combination
with multiple serum markers to predict cancer in women with a
pelvic mass or ovarian cyst. The predictive assay combines the
expression levels of 9 different genes and 4 different serum
markers, to detect ovarian cancer in women having surgery for an
abnormal pelvic mass. The results from the pilot trial demonstrated
a correct prediction of cancer with an ROC-AUC(1) of 95.1% for the
predictive assay. The novel test utilising gene analysis and serum
biomarkers achieved higher sensitivity and specificity than any
other test available for the same application.
Dr Richard Moore, Director of the Gynecologic Oncology Division,
University of Rochester Medical Center Wilmot Cancer Institute,
commented:
"The 200 patient ANG-003 clinical study shows that the next
generation ANGLE PMT test has the ability to out-perform current
clinical practice in accurately discriminating malignant from
benign pelvic masses prior to biopsy or surgery. The improved
accuracy of the test results in a high level of sensitivity as well
as a substantial reduction in false positives. The test also offers
key additional benefits over existing practice through the gene
expression information it provides, which may help to further guide
choices for targeted therapy in women with ovarian cancer."
The area under the receiver operating characteristic curve
(ROC-AUC)(1) evaluating the ability of the ANGLE PMT test to
differentiate between benign disease and cancer was 95.1%, a level
which is considered "Excellent". These results demonstrate the
potential for the PMT blood test to substantially out-perform
current tests in discriminating between benign and malignant pelvic
masses.
The PMT test is in the process of optimisation, with the goal of
further improving the assay's performance and potentially removing
the need for the serum marker testing results for the assay. The
PMT test offers both high sensitivity (correctly identifying
cancer) and high specificity (correctly identifying benign).
ANGLE's PMT blood test has the potential to assist in the
diagnosis of ovarian cancer prior to a patient undergoing a biopsy
or surgery. This will enable women with ovarian cancer to be
referred to gynaecologic oncology surgeons and institutions that
specialise in the care of women with ovarian cancer, giving them
the best possible outcome for the treatment of their disease. At
the same time, it will allow patients with a benign tumour to be
cared for in their communities and where appropriate to receive
minimally invasive surgery. This has the potential to reduce
healthcare costs and avoid the unnecessary transfer of patients
from their local hospital to specialist referral centres. The test
also has the potential to identify gene targets on the tumour that
may be used to inform treatment strategies.
The test utilises information from RNA based markers that could
not be obtained from analysis of ctDNA (circulating tumor DNA).
Approximately 5 to 10% of women will be diagnosed with a pelvic
mass during their lifetime, with 13 to 21% of these women being
subsequently diagnosed with ovarian cancer.
Combining its new downstream technology the Ziplex(R) system
with its existing CTC harvesting technology the Parsortix(TM)
system allows ANGLE to capture a larger part of the value chain.
ANGLE estimates that the market size for its combined PMT test for
this clinical application alone is worth US$1 billion per
annum.
Once optimisation of the PMT Test is completed, the next step
will be to evaluate performance in a study utilising a separate set
of patients.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"The results presented at SGO are a major endorsement for ANGLE.
The excellent performance of ANGLE's Parsortix system in this large
scale clinical study for the detection of ovarian cancer
demonstrates the capability of ANGLE's CTC system to out-perform
current approaches for the detection of ovarian cancer. ANGLE is
now working to bring this clinical application to the market. This
study is an exemplar of the level of accuracy that can be achieved
with the Parsortix liquid biopsy tests as we simultaneously
progress applications in metastatic breast cancer and prostate
cancer."
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 - Adrian
Hargrave, Simon Hicks, Kate
Bannatyne
Corporate Broking - Alice Lane,
Nikita Jain +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
Evan Smith, Anne Troy (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
1. The area under the curve (AUC) for a receiver operating
characteristic (ROC) plot, a plot of 1-specificity on the x-axis
vs. the sensitivity on the y-axis at each possible threshold for a
test's results, is a measure of the test's accuracy. The accuracy
of the test depends on how well the test separates the two groups
being tested into those with the outcome (sensitivity) and those
without the outcome (specificity) in question. An AUC of 1 (100%)
represents a perfect test while an AUC of 0.5 (50%) represents a
worthless test. The traditional academic classification system for
ROC-AUCs is 90% to 100% = excellent; 80% to 90% = good; 70% to 80%
= fair; 60% to 70% = poor; 50% to 60% = fail. Source: University of
Cambridge MRC Unit
http://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc
About Dr Richard Moore, Director of the Gynecologic Oncology
Division, University of Rochester Medical Center Wilmot Cancer
Institute
https://www.urmc.rochester.edu/people/29638888-richard-g-moore
Dr. Moore comes to UR Medicine from Brown University and Women
& Infants Hospital of Rhode Island. A native of Montreal,
Quebec, Canada, Dr. Moore graduated from the University of Alberta
Medical School in Edmonton. He completed his residency at Eastern
Virginia Graduate School of Medicine, where he also served as
Administrative Chief Resident. He completed a fellowship in
Gynecologic Oncology and Breast Surgery at Women & Infants
Hospital/Brown University. Dr. Moore joined the faculty at Women
and Infants/Brown University after leaving fellowship. He served as
the Associate Director of the Program in Women's Oncology since
2009 and was the Director of the Center for Biomarkers and Emerging
Technology as well as the Molecular Therapeutics laboratory.
Dr. Moore is board-certified in gynecologic oncology and is a
fellow of the American College of Obstetricians and Gynecologists
and a fellow of the American College of Surgeons.
In addition to his clinical interest in ovarian and endometrial
cancers, Dr. Moore is recognized internationally as a leading
expert on the use of biomarkers to detect ovarian cancer. He led
the team that developed the Risk of Ovarian Malignancy Algorithm
(ROMA), a test that is cleared for use in Europe and Asia and was
recently cleared by the U.S. Food and Drug Administration to detect
ovarian cancer in women who have an ovarian cyst or pelvic
mass.
Dr. Moore will see patients at 125 Lattimore Road, Suite 258 and
will perform surgeries at Highland Hospital, which has been awarded
the Gold Seal of Approval by the Joint Commission and leads the
state in the number of minimally invasive, robotic surgeries for
gynecologic cancer performed each year.
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 for
Europe 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 highly multiplexed, rapid
and sensitive capture of targets from a wide variety of sample
types. A proprietary chemistry allows for the capture and
amplification of over 100 biomarkers simultaneously in a single
reaction. These technologies can be combined to provide fully
automated, sample to answer results in both centralised laboratory
and point of use cartridge formats. It is ideal for measuring gene
expression and other markers directly from Parsortix harvests.
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/
This information is provided by RNS
The company news service from the London Stock Exchange
END
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