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Biocartis Group NV: Two Performance Studies on Idylla(TM) MSI Biomarkers Selected for Publication at ASCO Conference

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05/17/2018 | 07:01am CEST

PRESS RELEASE: 17 May 2018, 07:00 CEST

Two Performance Studies on Idylla(TM) MSI Biomarkers Selected for Publication at
                                ASCO Conference

Mechelen,   Belgium,   17 May  2018 -  Biocartis  Group  NV  (the  'Company'  or
'Biocartis'),  an innovative  molecular diagnostics  company (Euronext Brussels:
BCART),  today  announces  that  two  studies  conducted in cooperation with the
Flemish  Institute  for  Biotechnology  (VIB)  regarding  the performance of its
exclusively  licensed  novel  set  of  biomarkers for microsatellite instability
(MSI) that are included in the Idylla(TM) MSI Assay (the 'MSI Biomarkers'), have
been  selected  for  publication  at  the  ASCO  (American  Society  of Clinical
Oncology) Annual Meeting, taking place between 1-5 June 2018 in Chicago, US. The
first  study uses  the prototype  Idylla(TM) MSI  Assay in  finalized design and
shows  superior performance of  the MSI test  compared to reference methods. The
second study underlines the potential of Biocartis' MSI Biomarkers[1] to be used
as  a  companion  diagnostic  to  predict  immunotherapy  outcome in MSI-High[2]
endometrial and colorectal tumors.

MSI  is the result of  inactivation of the body's  so-called DNA mismatch repair
(MMR)  system. Consequently, errors that normally spontaneously occur during DNA
replication are no longer corrected, contributing to tumor growth and evolution.
Detection  of  MSI  is  currently  recommended  for all patients with colorectal
cancer  (CRC). Current MSI  testing methods rely  on manual, lengthy and complex
procedures  involving amongst others obtaining and testing of a second reference
sample.  The fully automated Idylla(TM) MSI  Assay is expected to overcome these
drawbacks,  providing results within 150 minutes from  just one slice of FFPE[3]
tumor tissue, without requiring a reference sample.

The  first study[4] used the prototype  Idylla(TM) MSI cartridges in a finalized
design,  containing  a  new  set  of  seven  MSI Biomarkers, consisting of short
homopolymers  located in the ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2
genes,  to test 348 FFPE colorectal cancer  samples[5] on their MSI status (i.e.
MSI-High(2)  or Microsatellite stable). A  concordance analysis with a reference
methodology[6]  showed an overall agreement of 96.1%. Of the discordant results,
fourteen  cases  were  classified  as  MSI-High by Idylla(TM) but Microsatellite
stable  (11) or invalid (3) by the reference method. Based on these results, the
study  concluded that  the prototype  Idylla(TM) MSI  Assay is capable of faster
detection  with  excellent  sensitivity  and  significantly less invalid results
compared to reference molecular testing for MSI.

The  second study[7], based on 33 samples,  demonstrated that the MSI Biomarkers
reliably  identified MSI-High status in endometrial and colorectal cancer[8] and
that  MSI-High is correlated to the total insertion-deletion (indel) load of the
tumor.  These  indel  mutations  increase  tumor  responsiveness  to  checkpoint
blockade  immunotherapies, which is a type of immunotherapy where the power of a
patient's  immune  system  is  harnessed  to  attack tumors. Checkpoint blockade
immunotherapies  were recently  US FDA  approved for  the treatment  of MSI-High
tumors.  As such, the study concluded  that the MSI Biomarkers could potentially
be used to predict immunotherapy outcome in MSI-High tumors.

Prof.  Diether Lambrechts,  Director of  the VIB  - KU  Leuven Center for Cancer
Biology,  commented: "These studies clearly show  the high clinical value of the
MSI  Biomarkers,  first  identified  in  our  lab  and  now meticulously further
selected  to a set of  seven biomarkers by Biocartis  that are combined with the
advantages of the fully automated Idylla(TM) system. The seven biomarkers show a
remarkable  association with both tumor mutational  burden and total indel load.
This  provides us with  a potential novel  and easy-to-implement tool to predict
tumor response to checkpoint blockade immunotherapy".

Herman  Verrelst, CEO Biocartis,  reacted: "The selected  ASCO studies once more
demonstrate the innovative nature of the Idylla(TM) MSI Assay that we have under
development. In our view, the unique features of this test are of great value to
the  pharmaceutical industry that needs rapid, reliable and easy MSI testing for
a  broad rollout of  their immune-oncology treatments.  Together we could enable
more patients with MSI-High tumors to benefit from these promising immunotherapy
treatments."

The  launch  of  Biocartis'  fully  automated  Idylla(TM)  MSI Assay (RUO[9]) is
planned for H2 2018.

                                  --- END ---

More information:

Renate Degrave
Manager Corporate Communications & Investor Relations
e-mail    [email protected]
tel         +32 15 631 729
mobile   +32 471 53 60 64


About BiocartisBiocartis  (Euronext  Brussels:  BCART)  is  an innovative molecular diagnostics
(MDx)  company providing next generation diagnostic solutions aimed at improving
clinical  practice for the benefit of patients, clinicians, payers and industry.
Biocartis'  proprietary MDx Idylla(TM) platform  is a fully automated sample-to-
result,  real-time PCR (Polymerase Chain  Reaction) system that offers accurate,
highly  reliable molecular information  from virtually any  biological sample in
virtually  any setting. Biocartis launched  the Idylla(TM) platform in September
2014. Biocartis  is  developing  and  marketing  a  rapidly  expanding test menu
addressing  key unmet clinical needs in  oncology and infectious diseases. These
areas represent respectively the fastest growing and largest segments of the MDx
market  worldwide.  Today,  Biocartis  offers  fourteen  oncology  tests and two
infectious  disease tests in  Europe. More information: www.biocartis.com. Press
Photo Library available here. Follow us on Twitter: @Biocartis_.

Biocartis  and Idylla(TM) are registered trademarks in Europe, the United States
and  other countries. Biocartis trademark and  logo and Idylla(TM) trademark and
logo  are used trademarks belonging to Biocartis.  This press release is not for
distribution,  directly or indirectly, in any  jurisdiction where to do so would
be  unlawful. Any persons reading this press release should inform themselves of
and  observe any  such restrictions.  Biocartis takes  no responsibility for any
violation  of any such restrictions  by any person. Please  refer to the product
labeling  for applicable  intended uses  for each  individual Biocartis product.
This  press release does not  constitute an offer or  invitation for the sale or
purchase  of securities in  any jurisdiction. No  securities of Biocartis may be
offered  or sold in  the United States  of America absent  registration with the
United   States   Securities  and  Exchange  Commission  or  an  exemption  from
registration under the U.S. Securities Act of 1933, as amended.

Forward-looking statements

This  press release may contain forward-looking statements. Such forward-looking
statements  are  not  guarantees  of  future  performance. These forward-looking
statements  speak only as of the date of this press release. Biocartis expressly
disclaims  any obligation or undertaking to  release any updates or revisions to
any  forward-looking statements  in this  press release,  except if specifically
required  to do so by law or regulation.  You should not place undue reliance on
forward-looking statements.

--------------------------------------------------------------------------------

[1]  The MSI Biomarkers were identified  by Prof. Diether Lambrechts' laboratory
and exclusively licensed to Biocartis from VIB in 2013.

[2]  MSI-High tumors share certain characteristics,  such as high tumor mutation
burden  with a  high number  of insertion-deletion  (indel) mutations, which are
likely  to result  in the  production of  neo-antigens, attracting  the adaptive
immune  system  and  therefore  more  likely  to  respond to checkpoint blockade
immunotherapies.  Antigenicity is  the capacity  of a  molecule or an antigen to
induce  an immune  response that  is to  be recognized  by and  interact with an
immunologically    specific    antibody    or    T-cell    receptor.    (Source:
https://www.biology-online.org/dictionary/Antigenicity, last consulted online on
17 April 2018).

[3] FFPE = formalin fixed, paraffin embedded.

[4]  B.  De  Craene  et  al.,  "Detection of microsatellite instability (MSI) in
colorectal  cancer samples with a novel set of highly sensitive markers by means
of  the Idylla(TM)  MSI Assay  prototype", ASCO  Annual Meeting  of the American
Society of Clinical Oncology, 1-5 June 2018, Chicago, US.

[5]  Patient samples of several clinical  sites and different ethnic groups were
included to assess robustness of marker selection.

[6]  All  samples  were  tested  with  a reference methodology for MSI detection
(Promega MSI analysis system).

[7] H. Zhao et al., "A novel set of 7 homopolymer indels for detection of MSI is
associated  with tumor mutation  burden and total  indel load in endometrial and
colorectal  cancers", ASCO  Annual Meeting  of the  American Society of Clinical
Oncology,  1-5 June 2018, Chicago, US. The methodology used for detection of the
seven  biomarkers, TMB (tumor mutation burden,)  and indel load, was whole-exome
sequencing.

[8]  The  study  method  used  the  mutation  landscape  of  14 endometrial  and
colorectal  MSI-High tumors  that were  previously characterized  by whole-exome
sequencing (Zhao et al., Elife 2014), and identified indels in homopolymers that
recurrently  affect MSI-High  tumors (frequency  up to  80% per tumor  type). An
additional  19 MSI-High tumors  were positive  for at  least 2 out  of 7 indels,
while  Microsatellite stable  tumors were  positive for  none of them. The study
further  correlated the number of positive  indels in all available MSI-H tumors
(n=19+14) with mutation load.

[9] RUO = Research Use Only.




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
    
Source: Biocartis Group NV via GlobeNewswire

 
  

© InPublic, source European Press Releases

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