Market Overview

Chronix Biomedical: Study Results on Cell-Free DNA Test for Kidney Transplantation Presented at AACC - Product Launch in US in near Term

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  • Results of prospective study using graft-derived circulating free
    DNA as biomarker for rejection in organ transplantation presented at
    the American Association of Clinical Chemistry (AACC) annual meeting
  • Chronix test provides means to monitor patients for early signs of
    rejection
  • Chronix will launch test in EU and USA

Chronix Biomedical, Inc., a developer of novel blood-based molecular
diagnostics, reports that a review of clinical studies of its TherasureTM
Transplant Monitor test for early signs of organ transplant rejection in
solid organ transplantation was presented yesterday at the American
Association of Clinical Chemistry (AACC) annual meeting.

The presentation was made in an oral session by Chronix's academic
collaborator Dr. Michael Oellerich (MD, Hon MD, FAACC, FAMM, FFPath
(RCPI), FRCPath) Professor of the University Medical Centre Goettingen,
Germany and former president of WASPaLM. Dr Oellerich presented detailed
results from a prospective study of Chronix's TherasureTM
Transplant Monitor in kidney transplant recipients1, and
reviewed data from separate and previously published studies in liver
and heart transplants.

Dr Oellerich asserted that the data shows that TherasureTM
Transplant Monitor can be used successfully to achieve an early
indication of rejection episodes and therefore would allow quick post
transplant treatment modification to prevent organ damage.

Chronix's TherasureTM Transplant Monitor measures
graft-derived cell-free DNA (GcfDNA) in blood, as a biomarker for early
signs for acute rejection and organ health, which can avoid the need for
patients to undergo unnecessary biopsies. Periodic monitoring via a
blood test for signs of rejection post transplantation allows physicians
to individually adjust levels of immunosuppression given to patients to
avoid risk of full blown rejection. Unnecessary biopsies are performed
frequently since conventional markers indicate the need for a biopsy
when no biopsy is necessary. The Chronix test can avoid such unrequired
biopsies. In addition the weakness in conventional markers is that they
are not sensitive enough to detect subclinical but long lasting chronic
rejections.

Chronix has now conducted multicentre studies of TherasureTM
in more than 500 solid organ transplantation recipients, the results of
which have been published in peer reviewed journals and presented at
scientific conferences2,3. The work has been supported by
grant funding from the German Federal Ministry of Education and Research.

One important finding indicated on the accompanying AACC poster
presentation, is that the Chronix test quantifies an absolute amount of
GcfDNA in the blood that is released by the transplanted organ4.
This is significant because the absolute amount of GcfDNA in the blood
of a transplant recipient is seen to be superior over the usually
reported percentage value within the background cfDNA for rejection
detection in kidney transplant. TherasureTM Transplant
Monitor is the only product on the market that provides such
quantification.

Dr Oellerich summarized: "The clinical benefit of GcfDNA determination
for transplant recipients is now well established. The TherasureTM
test we used in our studies, has a broad quantifiable range from 0.15%
to 100%, which is superior to existing tests on the market, which is
covered by Medicare with only 0.2% to 16%. In liver recipients higher
values than 16% are very common in rejection so that such low linear
range assays cannot be applied. In kidney transplantation, TherasureTM
Transplant Monitor with the unique feature of absolute quantification is
helpful to avoid unnecessary biopsies and has the potential to identify
unrecognized under-immunosuppression in patients carrying the risk for
de novo donor specific antibody formation leading to late graft loss."

The data shows that TherasureTM has a broader applicability
than competitor tests in terms of detecting early transplant rejection
of all major solid organ transplants. The company is currently
introducing it's TherasureTM product line in European
countries with a commercial partner laboratory and will enter the US
market in the next 12 months.

Chronix Biomedical's chief executive officer and chief medical officer
Dr Ekkehard Schütz, M.D., Ph.D., FAACC commented: "We are delighted
that results from this prospective study were selected for oral
presentation at the AACC. Our goal was to develop a test that serves the
clinical need, so it should have a short turnaround time (1 day) and
reasonable cost (below $600), to make serial determination during the
course of a patient with a organ transplant affordable. In our
experience, doctors seek a short turnaround time rather than having to
wait a week for a test result to help them make a treatment decision.
Both goals have been met, and now that our test has been launched in EU,
we intend to offer our TheraSure
TM TX-monitor
through a CLIA lab and distributing labs in the US in the near term."

Mr. John DiPietro, CFO of Chronix stated: "Physicians should
certainly welcome the Chronix Therasure
TM test
that will be marketed at around a quarter of the Medicare reimbursement
price of the tests currently available in the US. We expect Insurance
companies to welcome a test that is broadly applicable to all
transplants and less expensive to detect and monitor organ transplant
rejection. We want to provide products that are affordable and accurate.

We now have available in the marketplace the Chronix transplantation
test for monitoring of patients receiving all major solid organ
transplants such as heart, liver and kidney. Therasure
TM
Transplant Monitor should be very inviting to both physicians and
insurance companies."

About Chronix Biomedical

Chronix Biomedical, Inc. is a US-based molecular diagnostics company
developing blood tests for use in cancer treatment and organ
transplantation. Chronix's TherasureTM CNI Monitor for cancer
uses proprietary algorithms to derive a copy number instability (CNI)
score from sequencing of circulating cell-free tumour DNA (cfDNA), which
can be used in the prognosis, diagnosis and monitoring of therapeutic
response to cancer. Chronix TherasureTM Transplant Monitor
quantifies the amount of graft derived cell-free DNA in organ
recipients, to detect early rejection of organ transplants and better
identify the transplant will be accepted. For more information visit: www.chronixbiomedical.com.

References

1 Absolute quantification of graft-derived cell-free DNA as a
marker of rejection and graft injury in kidney transplantation - results
from a prospective observational trial (Oellerich et al. AACC 2018).

2 Graft-derived cell-free DNA - a promising rejection marker
in cardiac transplantation - Results from a prospective observational
trial (Schütz et al, AACC Annual meeting eBook 2017:
A-121).

3 Graft-derived cell-free DNA, a non-invasive early rejection
and graft damage marker in liver transplantation: A prospective,
observational, multicenter cohort study.(Schütz et al.
Plos Medicine 2017), (see
link
)

4Absolute Quantification of Graft derived cell-free DNA
(GcfDNA) early after Liver Transplantation (LTx) using droplet Digital
PCR. (Beck J et al. Clin Chem,2014: suppl. Meeting Abstract B-215)

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