TIDMAGL
RNS Number : 0755B
Angle PLC
29 September 2022
For immediate release 29 September 2022
ANGLE plc ("the Company")
ANGLE REPORTS POSITIVE HEADLINE RESULTS FROM OVARIAN CANCER
CLINICAL VERIFICATION STUDY
Parsortix test successful in discriminating malignant and benign
abnormal pelvic masses from a simple blood draw for detection of
ovarian cancer
Best in class results indicate the potential to reduce both
false positives and false negatives by 50% or more
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy
company, is delighted to announce positive headline results from
its ovarian cancer clinical verification study, demonstrating that
a Parsortix (R) blood test can be used to determine if a woman is
at risk of a malignant pelvic mass. Following the recent FDA
clearance and CE Marking of the Parsortix PC1 system for use in
metastatic breast cancer, this achievement marks another important
milestone in the Company's commercialisation strategy.
The study evaluated blood samples from patients diagnosed with a
pelvic mass and was led by Dr Richard Moore at the University of
Rochester Medical Centre, Wilmot Cancer Institute in New York,
Unites States. 144 patients (48 of which were found to have a
malignancy following surgery) had blood samples shipped to ANGLE's
laboratory for processing and evaluation. The population of cells
captured and harvested using the Parsortix system were evaluated
using ANGLE's Landscape(+) Ovarian assay to determine the
expression levels of 164 different gene transcripts. Analysis of
the data produced an algorithm for the prediction of the risk of
malignancy that combines the physician's initial cancer risk
assessment (benign vs. malignant), the patient's age, and the RNA
expression levels of 23 different genes.
The area under the receiver operating characteristic curve
(ROC-AUC) for this predictive algorithm was 95.4%, a level which is
considered "Excellent" (1) . Employing a threshold of >=40% for
the risk probability (a value of between 0 - 100% that is generated
by the algorithm using the patient specific inputs) resulted in a
sensitivity of 90%, a specificity of 93%, a positive predictive
value (PPV) of 86%, a negative predictive value (NPV) of 95%, a
false positive rate (FPR) of 7%, a false negative rate (FNR) of
10%, and an accuracy of 92%. Compared to the physician's initial
cancer risk assessment for this patient cohort (which had a
sensitivity of 75%, a specificity of 86%, a PPV of 74%, a NPV of
87%, a FPR of 14%, a FNR of 25% and an accuracy of 83%), the
predictive algorithm would significantly aid the physician in their
risk assessment, and in particular, reduced both the FPR and the
FNR by 50% or more.
The performance of the Parsortix Landscape(+) Ovarian assay in
this study was in-line with the high level of accuracy demonstrated
in an earlier 200 patient multicentre clinical study reported in
2018 (ROC-AUC 95.1%) and achieved the Company's objective of best
in class results with both sensitivity and specificity of 90% or
greater.
ANGLE believes the clinical data reported today provides a clear
demonstration of the value of the Parsortix harvest of circulating
tumour cells as the "best sample" for subsequent analysis as a
liquid biopsy. This is possible because the Parsortix system
recovers intact living cancer cells in the patient blood, which
contrasts with other tests based on free-floating proteins that can
be upregulated for reasons other than cancer.
In contrast to ANGLE's previously reported MAGIC algorithm (2) ,
the new algorithm utilises more comprehensive gene expression
information derived from blood samples shipped overnight to a
central laboratory, uses a lysis buffer that does not require the
separate extraction of RNA from the population of cells captured by
the Parsortix system, and does not directly rely on the use of
serum biomarkers. The clinical results therefore demonstrate the
ability to undertake complex molecular analysis of the Parsortix
harvest and confirms its suitability for use in both hospital
laboratories and central laboratories requiring sample shipping.
ANGLE believes that these key findings provide evidence of the
potential for widespread use of the Parsortix system for molecular
analysis in numerous different cancer applications adding greatly
to the value of the FDA cleared Parsortix system.
Following these excellent results, ANGLE is finalising detailed
plans for the commercialisation of Parsortix Landscape(+) molecular
assays including, but not limited to, ovarian cancer and will
update the market once these are complete.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"Demonstration of clinical utility of the Parsortix system is a
key strategic goal for ANGLE, so the excellent results from this
study are validation of what can be achieved in a demanding
clinical setting. Further, these results demonstrate the capability
to undertake a complex molecular analysis of the Parsortix harvest
in a real world setting. This important capability has potentially
numerous, widespread alternative uses, reinforcing our belief that
a Parsortix harvest of circulating tumour cells from a liquid
biopsy offers the "best sample" for clinicians seeking actionable
information to guide patient cancer treatment."
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.
https://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc
2. Moore RG, Khazan N, Coulter MA, Singh R, Miller MC,
Sivagnanalingam U, DuBeshter B, Angel C, Liu C, Seto K, Englert D,
Meachem P and Kim KK. Malignancy Assessment Using Gene
Identification in Captured Cells ("MAGIC") Algorithm for the
Prediction of Malignancy in Women With a Pelvic Mass. Obstet
Gynecol Online ahead of print, September 08, 2022.
https://pubmed.ncbi.nlm.nih.gov/36075062/
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Andrew Holder, Head of Investor Relations
Berenberg (NOMAD and Joint Broker)
Toby Flaux, Ciaran Walsh, Milo Bonser +44 (0) 20 3207 7800
Jefferies (Joint Broker)
Max Jones, Thomas Bective +44 (0) 20 7029 8000
FTI Consulting
Simon Conway, Ciara Martin +44 (0) 203 727 1000
Matthew Ventimiglia (US) +1 (212) 850 5624
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the EU Market Abuse Regulation (596/2014) . Upon the publication of
this announcement via a regulatory information service, this
information is considered to be in the public domain.
For Frequently Used Terms, please see the Company's website on
https://angleplc.com/investor-relations/glossary/
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 a circulating tumor cell (CTC) harvesting
technology known as the Parsortix(R) system and a downstream
analysis system for cost effective, highly multiplexed analysis of
nucleic acids and proteins.
ANGLE's Parsortix(R) system is FDA cleared for its intended use
in metastatic breast cancer and is currently the first and only FDA
cleared medical device to harvest intact circulating cancer cells
from blood.
Intended use
The Parsortix(R) PC1 system is an in vitro diagnostic device
intended to enrich circulating tumor cells (CTCs) from peripheral
blood collected in K(2) EDTA tubes from patients diagnosed with
metastatic breast cancer. The system employs a microfluidic chamber
(a Parsortix cell separation cassette) to capture cells of a
certain size and deformability from the population of cells present
in blood. The cells retained in the cassette are harvested by the
Parsortix PC1 system for use in subsequent downstream assays. The
end user is responsible for the validation of any downstream assay.
The standalone device, as indicated, does not identify, enumerate
or characterize CTCs and cannot be used to make any
diagnostic/prognostic claims for CTCs, including monitoring
indications or as an aid in any disease management and/or treatment
decisions.
The Parsortix system enables a liquid biopsy (a simple blood
test) to be used to provide the circulating metastatic breast
cancer cells to the user in a format suitable for multiple types of
downstream analyses. The system is based on a microfluidic device
that captures cells based on a combination of their size and
compressibility. The system is epitope independent and can capture
all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as
well as CTC clusters in a viable form (alive). CTCs harvested from
the system enable a complete picture of a cancer to be seen; as
being an intact cell they allow DNA, RNA and protein analysis as
well as cytological and morphological examination and may provide
comparable analysis to a tissue biopsy in metastatic breast cancer.
Because CTC analysis is a non-invasive process, unlike tissue
biopsy, it can be repeated as often as needed. This is important
because cancer develops and changes over time and there is a clear
medical need for up-to-date information on the status of a
patient's tumor. In addition, the live CTCs harvested by the
Parsortix system can be cultured, which offers the
potential for testing tumor response to drugs outside the
patient.
The Parsortix technology is the subject of 26 granted patents in
Europe, the United States, China, Australia, Canada, India, Japan
and Mexico with three extensive families of patents are being
progressed worldwide.
In the United States, the Parsortix(R) PC1 system has received a
Class II Classification from FDA for use with metastatic breast
cancer patients. FDA clearance is seen as the global gold standard.
ANGLE's Parsortix system is the first ever FDA cleared system for
harvesting CTCs for subsequent analysis. ANGLE has applied the IVD
CE Mark to the same system for the same intended use in Europe.
ANGLE has also completed two separate 200 subject clinical
studies under a program designed to develop an ovarian cancer
pelvic mass triage test, with the results showing best in class
accuracy (AUC-ROC) of 95.1%. The pelvic mass triage assay has
undergone further refinement and optimisation and a 200 patient
clinical verification study has now completed enrolment.
ANGLE's technology for the multiplex evaluation of proteins and
nucleic acids of all types is called the HyCEAD (TM) platform 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 (the HyCEAD method) allows for the capture and
amplification of over 100 biomarkers simultaneously in a single
reaction. The HyCEAD system is extremely sensitive and is ideal for
measuring gene expression and other markers directly from Parsortix
harvests and was used in the ovarian cancer pelvic mass triage test
to achieve best in class accuracy (AUC-ROC) of 95.1%.
ANGLE's proprietary technologies can be combined to provide
automated, sample-to-answer results in both centralised laboratory
and point-of-use cartridge formats.
ANGLE has established formal collaborations with world-class
cancer centres and major corporates such as Abbott, Philips and
QIAGEN, and works closely with leading CTC translational research
customers. These Key Opinion Leaders (KOLs) are working to identify
applications with medical utility (clear benefit to patients), and
to secure clinical data that demonstrates that utility in patient
studies. The body of evidence as to the benefits of the Parsortix
system is growing rapidly from our own clinical studies in
metastatic breast cancer and ovarian cancer and also from KOLs with
70 peer-reviewed publications and numerous publicly available
posters from 31 independent cancer centres, available on our
website.
ANGLE has established clinical services laboratories in the UK
and the United States to accelerate commercialisation of the
Parsortix system and act as demonstrators to support product
development. The laboratories offer services globally to
pharmaceutical and biotech customers for use of Parsortix in cancer
drug trials and, once the laboratories are accredited and tests
validated, will provide Laboratory Developed Tests (LDTs) for
patient management.
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