Padma Sundar, Senior Vice President of Commercial , OncocyteTM

DetermaRx™ Stratification Test Identify Patients With Stage I-IIA Non-Squamous NSCLC Who May Benefit From Adjuvant Chemotherapy

Padma Sundar, Senior Vice President of Commercial , OncocyteTM

Padma Sundar Interview with:
Padma Sundar, Senior Vice President of Commercial , OncocyteTM  What is the background for this announcement? How common is Stage I-IIA non-squamous NSCLC?

 DetermaRxTM is a treatment stratification test to identify patients with Stage I-IIA non-squamous NSCLC who may benefit from adjuvant chemotherapy.

  • Stage I-IIA non-squamous NSCLC represents ~20% of the lung cancer population and 40,000 patients annually in the U.S.1
  • Patients with this diagnosis usually undergo surgical resection and are presumed “cured”. While these patients are presumed “cured”, the recurrence rate in early-stage NSCLC of 30-50%. Usually, these recurrences happen within the first two years after surgery and are likely due to the presence of occult distant metastasis at the time of surgery.2
  • Until now, there has not been a validated means of identifying which early-stage patients are at a higher risk of disease recurrence and require adjuvant chemotherapy, versus those patients that are likely cured by surgery alone.  What are the main findings of the underlying studies?

DetermaRxTM has been validated in multiple independent studies in over 1,600 patients and extensively published in prestigious peer-reviewed journals including Lancet, JAMA, and JTO.

In our study published in Clinical Lung Cancer in 2018, patients who had high- or intermediate-risk DetermaRxTM test results and were treated with adjuvant platinum-based chemotherapy had 91.7% 5-year disease-free survival (DFS) compared to 48.9% 5-year DFS for high/intermediate-risk patients who did not receive adjuvant chemotherapy. This is a significant difference in survival and shows the benefit of adjuvant chemotherapy when applied in the right patient population. 3

More data will be shared at this month’s IASLC North America meeting showing, in an expanded patient population, similar differences in survival between high-risk treated versus untreated patients.  What does the DetermaRx™ test?  Is it a ‘liquid biopsy”?  Will the test be widely available to clinicians?

DetermaRxTM is the only test available in lung cancer that can stratify patients based on their molecular risk of recurrence. DetermaRxTM is a 14-gene tissue-based molecular risk stratification test that utilizes a proprietary algorithm to categorize patients into high, intermediate, or low risk of disease recurrence. Physicians can utilize results to inform adjuvant therapy and surveillance decisions. It is not a liquid biopsy and is performed on tissue post-resection.

DetermaRxTM was commercially launched in January 2020 and is available nationwide. OncocyteTM has also obtained positive Medicare coverage from CMS and are in conversations with multiple private payors.  Is there anything else you would like to add? Any disclosures?

Results from the ADAURA trial, first published at ASCO in June of this year, showed the potential benefit of osimertinib in patients with EGFR-positive early-stage lung cancer. As a result of this, Oncocyte plans to offer EGFR mutation testing along with the DetermaRx proprietary test to give treating physicians not only risk stratification for potential adjuvant chemotherapy but also EGFR status to inform the use of targeted therapy.


1SEER database

2Chansky, et al. (2017) The IASLC Lung Cancer Staging Project: External validation of the revision of the TNM stage groupings in the eight edition of the TNM classification of lung cancer. J Thorac Oncol 12:1109

3Clin Lung Cancer 2018;19:58

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Last Updated on October 7, 2020 by Marie Benz MD FAAD