San Jose, CA, USA and Göttingen, Germany (2 November 2016) – Chronix Biomedical, Inc., a
developer of novel cancer blood-based molecular diagnostics, is pleased to update investors on the
progress of two clinical studies designed to further validate its blood tests for prognostic, diagnostic
and therapeutic monitoring applications in prostate and pancreatic cancers.
The studies use its unique proprietary algorithms to derive a copy number instability (CNI) score from
Next Generation Sequencing of circulating cell-free tumour DNA (cfDNA). The prostate cancer1 study
has been open for several months and is collecting blood samples from 1,500 men who have been
referred for a prostate biopsy following an abnormal PSA test or after a digital rectal examination.
Chronix Biomedical has recently obtained approval from the UK NHS Health Research Authority.
Enrolment is well underway with around one fifth of patients recruited to date from centres in the US,
the UK and Sweden. The study is expected to complete its patient accrual in mid-2017 and announce
results in early 2018.
In a previous retrospective study over 200 patients, Chronix and its collaborators showed that CNI
score could be used to discriminate between prostate cancer and non-cancer controls with a
diagnostic accuracy of 83%. The CNI score could also be used to distinguish BPH and prostatitis from
prostate cancer with a diagnostic accuracy of 90%. The results from this study were published in the
peer-reviewed journal Clinical Chemistry2 in 2015.
The current study will examine the correlation between the CNI and the tissue diagnosis of prostate
cancer. It will also examine whether CNI can be used to identify two other prostate conditions: benign
prostatic hyperplasia (BPH), a common and treatable non-cancerous enlargement of the prostate
gland, and prostatic intraepithelial neoplasia (PIN), a pre-cancerous condition usually managed by
Chronix already offers a CNI-based risk assessment tool for prostate cancer called the Second
Opinion Prostate Cancer Evaluation Test3. This test can be used as a supplementary evaluation to
assist clinicians in their decision making process on whether to refer for a tissue biopsy for a patient
with an elevated PSA level or a suspicious MRI or digital rectal examination. Chronix believes the use
of its Second Opinion Prostate Cancer Evaluation Test could reduce the high rate4 of false positives
associated with routine PSA testing that requires many patients to undergo unnecessary and invasive
The validation study is designed to demonstrate prospectively whether the CNI score can be used to
distinguish between prostate cancer and other non-cancerous prostate conditions, and improve early
diagnostic accuracy, reduce the number of prostate biopsies, reduce repeat biopsies and monitor
patients who are deemed at elevated risk5.
Chronix also reports that a study is now underway to evaluate Chronix’s Delta Dot therapeutic
monitoring test for predicting response to first-line gemcitabine or Folfirinox7 chemotherapy for
metastatic pancreatic cancer. This single-arm study in 100 patients will evaluate CNI scores prior to
the start of treatment and after the first, second and fourth cycles of chemotherapy. It will compare the
performance of the CNI as a therapeutic monitoring test with CA19-9, a marker currently used for
predicting response to chemotherapy in this tumour type.
Chronix and its collaborators published data8 earlier this year on the ability of the Delta Dot test to
predict response to chemo-, immuno- and radiotherapy after one or two cycles in multiple tumour
types including pancreatic cancer. Chronix is preparing a manuscript with updated trial data to a peer
reviewed journal for publication.
Chronix Biomedical’s CEO, Dr. Howard B. Urnovitz, commented:
“We are pleased to update shareholders with the progress we have made with study planning and
initiations this year, particularly since our presentations of data at AACR and ASCO. We expect to
initiate further studies in due course and intend to report regularly on our clinical progress.”
About Chronix Biomedical
Chronix Biomedical, Inc. is a US-based molecular diagnostics company developing blood tests for the
screening and monitoring of cancer. Chronix already offers supplemental screening evaluation tests
based on copy number instability for breast and prostate cancer. For more information visit
2 The Gleason score is most commonly used grading system in prostate cancer and an important tool for guiding
3Clin Chem. 2015 Jan;61(1):239-48. doi: 10.1373/clinchem.2014.226571. Epub 2014 Oct 2
4 The false-positive rate for an elevated sPSA is approximately 75%, based on pathologic evaluation of tissue
obtained by prostate biopsy (Arcangeli, Ornstein, Keetch, & Andriole, 1997)
5 Only about 25% of men who have a prostate biopsy due to an elevated PSA level actually have prostate cancer
(Barry MJ. Clinical practice. Prostate-specific-antigen testing for early diagnosis of prostate cancer. New
England Journal of Medicine 2001;344(18):1373-1377.)
6 The Second Opinion™ Prostate Cancer Evaluation Test is a laboratory development test and currently offered
in the UK, Germany and Poland through Chronix’s certified laboratories in Göttingen, Germany. It may only be
used as an aid to diagnosis.
7 Folfirinox is a chemotherapy regimen comprising folinic acid, fluorouracil, irinotecan and oxaliplatin.
8 Changes in tumor cell-free DNA copy number instability (CNI) predict therapeutic response in metastatic
cancers, Weiss et al, Cancer Research 76.14 Supplement (2016): 3138. Tumor cell-free DNA copy number
instability (CNI) to predict therapeutic response to immunotherapy prior to cycle 2. J Clin Oncol 34, 2016 (suppl;
Chronix Biomedical, Inc
Dr. Howard Urnovitz, CEO
+1 (408) 960-2307
Shard Capital Partners LLP
(Corporate Adviser and Broker)
Dr. Wang Chong
+44 20 7186 9948