Outsmart your patient’s lung cancer

Predict and prevent recurrence in patients with early-stage NSCLC with DetermaRx.

What is

DetermaRx?

Test Overview
How It Works
Data

DetermaRx is a 14-gene molecular stratification test that helps identify which patients with stage I and IIA non-squamous non-small cell lung cancer have a high risk of recurrence and may benefit from adjuvant chemotherapy.

DetermaRx is appropriate for all patients with stage IA, IB or IIA non-squamous NSCLC with a tumor size of less than 5 cm and with no nodal involvement (N0), who have undergone surgical resection and are now being considered for chemotherapy in the next stage of their care.

DetermaRx testing can be performed on any NSCLC that has been resected. You’ll need to send tumor tissue to Oncocyte’s lab, where the molecular signature is analyzed to stratify your patient’s risk. EGFR mutation analysis is also available from the same tissue sample. Both results come back in time to facilitate post-operative discussion with patients about the potential benefit of adjuvant chemotherapy.

DetermaRx has been validated in two independent cohorts with close to 1400 patients. DetermaRx outperformed NCCN criteria in identifying patients at high risk for mortality from stage IA, IB, and IIB non-squamous NSCLC1.
In a single institution prospective study, patients identified by DetermaRx as high-risk and who were treated with adjuvant chemotherapy had 91.7% 5-year disease-free survival compared to 48.9% 5-year DFS for high-risk patients who did not receive chemotherapy2. In a study of physician practices, DetermaRx results led to a change in treatment recommendation for 30% of patients3.

1. Kratz, et al. (2012) A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international studies. Lancet 379:823.
2. Dormady, et al. (2015) The impact of a fourteen-gene molecular assay on physician treatment decisions in non-small-cell lung cancer. Int J Clin Oncol 20:59.
3. Woodard, et al. (2018) Adjuvant chemotherapy guided by molecular profiling and improved outcomes in early stage, non-small-cell lung cancer. Clinical Lung Cancer 19:58.

You can now

Identify which early-stage patients can benefit from chemotherapy

Roughly 40,000 patients are diagnosed with early-stage non-small cell lung cancer (NSCLC) each year1. 30-50% of early-stage patients will die within 5 years of their operation, despite complete surgical resection.

As a surgeon, there’s nothing worse than telling your patient their cancer has returned – especially when recurrence can be mitigated through adjuvant chemotherapy.

The NCCN recommends chemotherapy for patients with stage I and IIA NSCLC who are at a high risk for recurrence after resection, but does not provide validated criteria for identifying these high-risk patients. The first and only test of its kind, DetermaRx now offers clinicians a clear indication of which patients may be likely to benefit from adjuvant chemotherapy. Now paired with EGFR mutation analysis from the same tissue sample, DetermaRx + EGFR is the complete molecular testing solution in early-stage NSCLC, guiding treatment selection and sequencing of targeted therapy (osimertinib) and adjuvant chemotherapy. This leads to more confident treatment decisions for all of your stage I and IIA patients.
How Thoracic Surgeons feel

About DetermaRx

“I think that DetermaRx is practice-changing and very important for discussions that we have with patients. I like giving patients enough information about their situation, and the pros and cons of additional treatment after their operation, so they’re loaded with the information to help them decide if they want adjuvant treatment.”

Robert McKenna, MD
Thoracic Surgeon, John Wayne Cancer Institute 

A pioneer in

Precision treatment

DetermaRx is paving the way for improved stage I and IIA NSCLC outcomes, giving oncologists a way to more confidently identify and treat patients who likely harbor micrometastatic disease.

Good for your patients

DetermaRx offers insight into the best possible treatment decisions for your patients and may minimize the risk of under-treating patients who could benefit from chemotherapy and overtreating those for whom surgery is likely curative.

Good for your practice

Becoming an early adopter of this innovative predictive test can improve your confidence in patient care and continuity of management.

Running a DetermaRx Test

FAQs
What is DetermaRx?
DetermaRx is a 14-gene molecular treatment stratification test to identify patients with Stage IA, IB and IIA non-squamous NSCLC who may benefit from adjuvant chemotherapy following surgical resection.
What patients are candidates for DetermaRx?
DetermaRx is appropriate for all patients with Stage IA, IB or IIA non-squamous non-small cell lung cancer (NSCLC) with a tumor size of less than 5 cm and with no nodal involement (N0), who have undergone surgical resection and are now being considered for chemotherapy in the next stage of their care.
What will DetermaRx results show?
Results classify patients into low, intermediate, or high-risk of disease recurrence. In a non-randomized, prospective study of 250 patients who were surgically resected at a single institution, patients in the high- and intermediate-risk categories who were treated with adjuvant chemotherapy had significantly better survival than high- and intermediate-risk patients who did not receive chemotherapy.
What data is there to support DetermaRx?
DetermaRx has been clinically validated in two independent cohorts with close to 1400 patients (Kratz et al, Lancet, 2012). A prospective study found that test-identified high/intermediate risk patients who 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 chemotherapy. DetermaRx-identified low-risk patients had a disease-free survival (DFS) of 93.8% without adjuvant chemotherapy (Woodard et al, Clinical Lung Cancer, 2018). The significant difference in survival between treated vs. untreated high/intermediate-risk patients was reinforced in an expanded 250-patient prospective cohort, in which most patients were stage IA. (Woodard et al, North America Conference on Lung Cancer, 2020). A complete list of publications is available here.
How do I order DetermaRx?
You can register for an Oncocyte account here. You may then order the DetermaRx test, track testing progress and access test results in your physician portal. You can also contact us at 1-844-ONCOCYTE or customer.service@oncocyte.com to set up an account.
May I order EGFR mutation testing along with DetermaRx?
Yes. EGFR mutation testing (exons 18-21) is available from the same tissue sample. You may opt into EGFR testing when you order DetermaRx.
What are the sample requirements?
Oncocyte will provide a FFPE tissue shipping kit with detailed sample preparation and shipping instructions. We accept a tissue block or slides.
How long does it take to receive results?
Results are typically ready within 10 business days from the time we receive the specimen.
Are EGFR results available at the same time as DetermaRx results?
Yes. If you opt into EGFR mutation testing when you order DetermaRx, you will receive a consolidated report with both DetermaRx and EGFR results.
Is DetermaRx covered by insurance?
We accept all forms of insurance including Medicare. Medicare covers the DetermaRx test, but we are currently out of network with other insurances. Once we have completed a patient’s test, we send them a letter explaining our insurance and financial assistance process. Patients who would like to be pre-qualified for financial assistance, or have any questions regarding insurance billing, can contact us at 1-844-662-6298.

References
  1. SEER data.
  2. Chansky, 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.
  3. Kratz, et al. (2012) A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international studies. Lancet 379:823.
  4. Woodard, et al. (2018) Adjuvant chemotherapy guided by molecular profiling and improved outcomes in early stage, non-small-cell lung cancer. Clinical Lung Cancer 19:58.
  5. Woodard, et al. (2020) Molecular risk stratification is independent of EGFR mutation status in identifying early stage non-squamous non-small cell lung cancer patients at risk for recurrence and likely to benefit from adjuvant chemotherapy. Abstract presented at 2020 North America Conference on Lung Cancer.