Lung Cancer Diagnosis

Lung Cancer and Early Detection

Why we are tackling lung cancer first

While Micronoma’s approach indicates very strong performances across multiple cancers, including at the earliest stages (I and II)*, we are initially focused on developing an LDT for diagnosing lung cancer, since it is among the most common and the deadliest.

*Poore, G. D. et. al. (2020). Microbiome analyses of blood and tissues suggest cancer diagnostic approach. Nature. https://doi.org/10.1038/s41586-020-2095-1

Lung Cancer in the U.S.

25% of All
Cancer Deaths

Extrapolated from: Morgan, K. K.  (2021, September 1). WebMD. Your Chances of Surviving Lung Cancer. Retrieved from https://www.webmd.com/lung-cancer/guide/lung-cancer-survival-rates

The survival rate for patients whose lung cancer is detected in stage I is as high as 82 percent –
a 16-fold increase over patients detected in stage IV.¹

  At risk population is relatively well defined, but underserved

Micronoma’s OncobiotaLUNG^detect has the potential to provide early diagnosis to populations with a relatively well-defined risk profile compared to other cancers, namely the approximately 1.5 million people in the U.S. ages 50-plus who have smoked a pack or more of cigarettes per day for 20 years or more.²

That at-risk population must currently rely on low-dose CT (LDCT) scans for screening. While the scans are covered by Medicare, only about 5% of those eligible are going through the process. One reason is the lack of access to testing centers, especially in rural areas.³ But this is not the only reason.

Current methods post LDCT can be risky and costly

At least 96.4% of LDCT scans which reveal a lung nodule are later determined as benign. While good news for those patients, LDCT scans require tissue biopsies, which are costly. In addition, the procedure carries some serious risk, with about 20% of those tested experiencing side effects (lung infections, pneumothorax, etc.). Another procedure to determine if nodules are malignant is a PET CT scan. While this may be a little less costly than tissue biopsy, it relies on the injection of significant doses of radioactivity and lacks sensitivity in stage I of the disease (as low as 38%).⁴

More modern liquid biopsy technologies that test circulating tumor DNA (ctDNA) and proteins, and/or DNA methylation are available. But they often offer poor sensitivity or do not provide strong early-stage detection. ⁵

In the event of a positive LDCT scan, using a simple blood draw and OncobiotaLUNG^detect  provides another diagnostic option for clinicians and their patients, and could make it possible for patients to avoid more expensive and more invasive tissue biopsies by determining the likelihood of a lung nodule to be malignant via blood samples, even for nodules discovered in stage I of the disease.

Improving early cancer detections can ultimately save costs, time, and, most importantly, lives.

1. American Cancer Society (2019, October 1). Lung Cancer Survival Rates. Retrieved from https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html

2. Jonas DE, Reuland DS, Reddy SM, et al. Screening for Lung Cancer With Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021;325(10):971–987. doi:10.1001/jama.2021.0377

3. Fedewa, S. A. et. al (2021). State Variation in Low-Dose Computed Tomography Scanning for Lung Cancer Screening in the United States. Journal of the National Cancer Institute, 113(8), 1044–1052. https://doi.org/10.1093/jnci/djaa170

4. Chiu, Y. W. et. al. (2021). Costs of Biopsy and Complications in Patients with Lung Cancer. ClinicoEconomics and outcomes research : CEOR, 13, 191–200. https://doi.org/10.2147/CEOR.S295494

5. Adams, E., Sepich-Poore, G. D., Miller-Montgomery, S., Knight, R.. VIEW. 2022, 3, 20200118. https://doi.org/10.1002/VIW.20200118