DetermaDx

A liquid biopsy test to rule out malignancy in lung nodules (in development)

Rule out malignancyin lung nodules

Every year, more than 1.6 million people will be identified with having a suspicious lung nodule,1 and many will undergo invasive diagnostic procedures such as a lung biopsy.

1 in 5 of these diagnostic procedures results in a complication.2

We need a better way to understand which patients can avoid unnecessary diagnostic procedures.

DetermaDx

A liquid biopsy test intended to clarify whether a lung nodule is suspicious or likely benign, potentially reducing the need for risky and costly invasive diagnostic procedures.

About DetermaDx

DetermaDx utilizes a proprietary immune system interrogation approach to measure gene expression changes that signal the presence or absence of cancer.

Lung Nodule Identified

Non Invasive Liquid Biopsy

Immune Biomarker Analysis

Actionable Results to inform biopsy decision

Why DetermaDx

Identification

More than 1.6 million suspicious lung nodules are identified each year,1 but most of these nodules turn out to be benign.3,4

Complications

In a study of nearly 345,000 patients undergoing invasive lung diagnostic procedures (bronchoscopy, needle biopsy or surgery), 1 in 5 experienced a complication.2

Cost

The downstream cost of treating a serious complication associated with an invasive lung diagnostic procedure averages up to $56,000.2

Immune Response for Nodule Evaluation (IRENE)

• Ongoing clinical validation study with more than 2400 subjects
• 62 sites including both academic and community practices
• Largest reported cohort with pulmonary nodules 5-30 mm representative of U.S. patient population

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References

  1. Gould, et al. (2015) Recent trends in the identification of incidental pulmonary nodules. American Journal of Respiratory and Critical Care Medicine 192:1206.
  2. Huo, et al. (2019) Complication rates and downstream medical costs associated with invasive diagnostic procedures for lung abnormalities in the community setting. JAMA Internal Medicine 179:324.
  3. National Lung Screening Trial Research Team. (2011) Reduced lung-cancer mortality with low-dose computed tomographic screening. New England Journal of Medicine 365:395.
  4. Tanner, et al. (2015) Management of pulmonary nodules by community pulmonologists: A multicenter observational study. Chest 148:1405.