Up to two million incidentally detected pulmonary nodules (IPN) appear each year on
images coming from diagnostic scans that patients undergo for reasons unrelated to
lung cancer. These nodules are abnormal growths (neoplasms) that form in the lung
and, upon identification, need to be carefully evaluated for their potential malignancy.

Incidental findings arise in many clinical scenarios. For instance, someone gets into a
car accident and needs a chest x-ray to see how many broken ribs they may have. Or
someone with chronic back pain gets an x-ray of their spine. In these two example
scenarios, these patients are not seeing the doctor to be checked for lung nodules or
due to a suspicion that there is something wrong with their lungs, yet the imaging done
as part of their diagnostic work-up can reveal the presence of a pulmonary nodule.

The identification of an abnormality sparks the need for a clinician to answer various
questions, including whether the finding is a cause for concern and needs some kind of
intervention—such as a highly invasive lung tissue biopsy, continued monitoring, or
perhaps the ordering of blood work to look for abnormal blood chemistry.

In addition to the obvious concern for the patient’s well-being, these responses add
costs to the healthcare system.

While patients might not be exhibiting any symptoms and there is no reason to believe
they are sick, physicians still need to determine the nature and status of the nodule.
“From this large annual pool of incidentally detected pulmonary nodules, very few prove
to be bona fide thoracic malignancies,” said Micronoma Chief Scientific Officer, Eddie
Adams, Ph.D.

Here are some stats to ponder: While only about 5 percent to 10 percent of these IPN
actually turn out to be cancerous, they represent 90 percent of lung cancer cases

This is an unexpected situation given that, in the United States, we have lung cancer
screening guidelines recommended by the U.S. Preventative Services Task Force
(USPSTF), which serve to target those members of our population at the greatest risk of
developing lung cancer. Specifically, the USPSTF recommends annual screening for
lung cancer with low-dose computed tomography (LDCT) for adults aged 50 to 80 years
old who have a 20 pack-year smoking history and currently smoke or quit smoking
within the last 15 years.

And yet despite the existence of medically reimbursable lung cancer screening options,
only 10 percent or fewer of all lung cancers are detected following a lung cancer
screening protocol, due to a very low compliance rate from patients (fewer than 5%).
Compared to mammogram compliance (about 70%) and colonoscopy compliance
(about 60%), it is easy to see that much needs to be done to ensure that at-risk patients
undergo recommended screenings.

It is worth examining why so many lung cancers are incidentally discovered if there are
lung cancer screening guidelines and easy-to-use and painless imaging technology.

We could blame it on patients for not being sufficiently proactive about their healthcare.
But we need to consider the appeal of the guidelines themselves with our current
technologies: Follow-up imaging techniques (an additional LDCT scan or a PET-scan)
and ultimately, in many cases, a costly and risky lung tissue biopsy.

Monitoring a nodule for 3-6 months to determine if it needs further intervention might be
a reasonable course of action if it is, in fact, benign. But that also leaves open the
chance for an as of yet undiagnosed cancerous nodule to become more aggressive, not
to mention the stress for patients waiting for follow-up imaging to check if this still
uncharacterized abnormality has grown.

So, what can Micronoma do to assist patients with IPN or to help boost compliance for
the population at risk for lung cancer?

The answer is the OncobiotaLUNG platform. Our simple blood test helps filter out the
nodules with a low risk of malignancy thus reducing unnecessary tissue biopsies, while
flagging the worrisome nodules so that clinicians can fast-track interventions where
most needed.

Our diagnostic tool, which has received FDA Breakthrough Device Designation (BDD),
especially when PET CT scans are not an option or not accessible, stands to improve
patient outcomes by catching cancer earlier and avoiding potentially dangerous
biopsies, and will also cut costs by enabling pulmonary nodule management efficiencies
in the healthcare system.

OncobiotaLUNG operates in the sweet spot of cancer detection by combining cancer
risk probability scores based on imaging data with the identification of novel microbial
biomarkers circulating in the blood to determine if cancer is present.

“By decreasing the complexity of pulmonary nodule management using a biomarker-
driven liquid biopsy to segregate patient IPNs with a very high likelihood of malignancy
from those without, we can help save a lot of time, patient lives, and bring down
healthcare costs,” Eddie said.