Identifying responders to immunotherapies

DetermaIO is a proprietary gene expression test that assesses the tumor microenvironment. It is run in a CLIA/- CAP-accredited laboratory and is available for use in immunotherapy biopharma trials.

As many as 44%

of all newly diagnosed patients with cancer are eligible for immuno-oncology testing and therapy.1

Unfortunately, with standard of care PD-L1 IHC testing, more than half of PD-L1 positive patients do not respond to immune checkpoint inhibitors, and

1 in 6

patients who will respond are missed.2

We need a

better way

to identify the patients that will best respond to immunotherapies and avoid the cost and potential adverse effects of ineffective treatment.

About

DetermaIO

DetermaIO™ is a 27-target multivariate gene expression test performed on FFPE biopsy specimens that measures the presence of subtypes of infiltrating inflammatory cells, and the presence or absence of a differentiated stromal microenvironment. DetermaIO’s proprietary algorithm combines mRNA gene expression data and interprets the physiology of both the tumor and its surrounding micro-environment in order to predict the response to immuno-oncology therapies. Data supporting a strong association with response to checkpoint inhibitors has been shown in non-small cell lung cancer (NSCLC).3 The assay is currently offered for pharma service research only as a CLIA-certified real time PCR LDT from our CAP-accredited laboratory, or as an in silico interpretation of whole transcriptome RNA data.

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DetermaIO Performance

  • In patients with NSCLC treated with an immune checkpoint inhibitor, DetermaIO-identified responders (IM+) had significantly longer progression-free survival than DetermaIO-identified non-responders (IM-).3
  • In a study presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, data suggested that DetermaIO outperformed PD-L1 in predicting immunotherapy responders as well as non-responders.3

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DetermaIO Performance

DetermaIO

for Research

Identify immune checkpoint inhibitor responders.

Effective Results

Standard of care PD-L1 testing incorrectly identifies many patients as potential responders to immune checkpoint inhibitors, and misses certain other patients who may respond.2 Data from a recent study suggested that DetermaIO outperformed PD-L1 in identifying both responders and non-responders.3

Reduce Wasted Spend

Immuno-therapy can cost up to $300,000 per patient.4 Accurately identify the patients that are most likely to respond, reducing expensive drug costs for those that are unlikely to benefit.

Decrease Adverse Events

30% of patients experience a serious adverse event as a result of immune checkpoint inhibitor treatment.2 Avoid introducing potential adverse outcomes (including autoimmune disease) to patients for whom treatment is unlikely to be effective.

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    References

    1. Haslam and Prasad. (2019) Estimation of the percentage of US patients with cancer who are eligible for and respond to checkpoint inhibitor immunotherapy drugs. JAMA Network Open 2(5):e192535.
    2. Khagi et al. (2017) Next generation predictive biomarkers for immune checkpoint inhibition. Cancer Metastasis Rev 36:179.
    3. Hout et al. One-year progression-free survival in lung cancer patients treated with immune checkpoint inhibitors is significantly associated with a novel immunomodulatory signature but not PD-L1 staining. Poster presented at: Society for Immunotherapy of Cancer (SITC) Annual Meeting; Nov 6-10, 2019; National Harbor, Maryland.
    4. Institute for Clinical and Economic Review. (2016) Treatment Options for Advanced Non-Small Cell Lung Cancer: Effectiveness, Value and Value-Based Price Benchmarks. Final Evidence Report and Meeting Summary. Accessed October 2019.