Chronix Biomedical presents positive data on prognostic test in head/neck cancer study data at ASCO  

  • Study finds CNI score to be a stronger predictor of time to recurrence in head and neck cancer than current method based on lymph node invasion

San Jose, CA, USA and Göttingen, Germany (6 June 2017) – Chronix Biomedical, Inc., a developer of novel blood-based cancer molecular diagnostics, announces further details from its study of its copy number instability (CNI) score test in head and neck cancer following the poster presentation at the American Society of Clinical Oncology (‘ASCO’) Annual Meeting.

The company presented a poster entitled Cell-free DNA for treatment monitoring and outcome predictor in head and neck cancer on 5 June. The study enrolled 54 patients undergoing surgery for this cancer type and evaluated the Chronix test as a predictor of time to progression in comparison with the current method based on the degree of tumour invasion of lymph nodes (pN status).

This study found:

  • 29/42 patients with ≤T3 tumours and 11/12 with T4 tumours had elevated CNI scores, with significantly higher CNI scores seen for T4 tumours (p=0.04)1.
  • Patients with tumour lymph node invasion (n=37) had significantly higher CNI scores than those with negative lymph nodes (n=17), p= 0.0004.
  • CNI scores showed a steep decline after surgical resection and increased with disease progression.
  • Pre-operative CNI scores was a stronger predictor of time to recurrence (p=0.00007) than lymph node status (p=0.05).
  • High baseline CNI correlated with time to recurrence (p=0.018).

Lead author Dr Julia Beck of Chronix Biomedical commented:

“The study showed that CNI score can provide a more accurate prognostic tool for assessing time to progression than conventional staging based on clinical parameters. Given predicted time to progression is an important factor in the therapeutic decision post surgery, such a test has the potential to improve outcomes in this cancer.”

Chronix is developing a number of tests for the prognosis and diagnosis of cancer and, in particular, the real-time therapeutic monitoring of response to cancer therapy, based on its proprietary CNI score. Chronix and its collaborators have shown that CNI scores can accurately determine whether a patient is responding to treatment after just one or two cycles of therapy, potentially 6-8 weeks earlier than is possible using imaging-based methods. Such a test should allow treating physicians to identify non-responding patients quickly and switch them to alternative treatments sooner, avoiding unnecessary side-effects and potentially achieving better treatment outcomes.

Chronix Biomedical’s chief medical officer, Prof Ekkehard Schütz, commented:

“We believe the data suggest the test could also be used for therapeutic monitoring of adjuvant therapy in this indication.

 The company has presented results from studies in patients receiving radiotherapy, chemotherapy2 and immunotherapy3 and recently published the results of a clinical study in patients receiving immunotherapy in the journal, Clinical Cancer Research.4

About Chronix Biomedical

Chronix Biomedical, Inc. is a US-based molecular diagnostics company developing blood tests for the screening and monitoring of cancer. Chronix’s tests use 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. For more information visit

View the poster



1 T3 and T4 are stages under the TNM classification for head and neck cancer (see link).

2 Changes in tumor cell-free DNA copy number instability (CNI) predict therapeutic response in metastatic cancers, Weiss et al, American Association for Cancer Research 2016 Annual Meeting (see link).

3 Tumor cell-free DNA copy number instability (CNI) predicts therapeutic response to immunotherapy prior to cycle 2” Weiss et al.

4 Tumor Cell-Free DNA Copy Number Instability Predicts Therapeutic Response to Immunotherapy, Weiss et al. Clin Cancer Res. 2017 Mar 20. pii: clincanres.0231.2017. doi: 10.1158/1078-0432.CCR-17-0231.



Chronix Biomedical, Inc
Dr Howard Urnovitz, CEO
+1 (408) 960-2307

Shard Capital Partners LLP
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Dr Wang Chong
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