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 5cm 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 email@example.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 your 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 processes. 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.