Market Size

True Bearing Diagnostics, Inc. (the “True Bearing”) is developing TruNAV™, the world’s first highly accurate, host driven, RNA derived, blood based diagnostic tool designed for infection detection. 

What problem(s) are you addressing?

Each year, 13.7 million people die from infections globally, and 7.7 million of those deaths occur in the USA due to bacterial infections. True Bearing Diagnostics will be able to address these.

What is your proposed solution to the identified problem(s)?

True Bearing has developed a greater than 90% accurate RNA-based blood test to assist with diagnosing internal infections that will address a $50+ billion-dollar market. Our test looks at the patient immune response system through detecting neutrophil activation and the results provided include –

1.) binary answer as to the presence or lack of infection

People with chronic pain… If no infection, there is no need for antibiotics and the physicians will be informed to be more efficient in the discovery process and enabled to look elsewhere for causes – possibly allergy, injury or psychosomatic causes.

2.) Once infection is detected – into what bucket(s) does the infection fall? Bacterial, Viral, and/or Biofilm

Next steps: if there is a bacterial component, then it might make sense to prescribe antibiotics

3.) Once infection is detected, what is the magnitude of the infection?

This last part allows the physician to track the progress of the therapy that is undertaken. (think antibiotics – after course of antibiotics has been completed, is the infection resolved or does further action need to be undertaken?)

Initially focused on abdominal infections, our TruNAV test fills a large diagnostic void in medicine.

In 2020, there were 11 million emergency department (ED) visits for the narrow diagnosis of “Stomach and abdominal pain” (Table 1) (1). On average from 2007-2013 there were 20.3 million emergency department visits for the larger class of abdominal and digestive diseases (1, 2). However, of people experiencing acute abdominal pain, only about half go to an ED, with the other half going to a primary care physician (2). Furthermore, of people that experience abdominal pain, only about half seek medical care of any type (2). Thus, the abdominal pain market is certainly several times larger than the 11 million patients that present to the ED. From very large survey analysis of 10,000 patients with abdominal pain (2) and other analyses, we reconstructed roughly the distribution of abdominal pain cases according to how they are likely to seek medical care (Table 1). We estimate that there are at least 28.5 million visits to the emergency urgent care, and doctor offices each year for abdominal pain. See the Table 1 below for the breakdown by type of visit. TruNAV would be appropriate for a large fraction of these patients in which an intra-abdominal infection is considered possible. 

Who are your key competitors in your space?

Currently available tools for detecting an intra-abdominal infection (IAI) include a fever, an elevated white blood cell count (+/- 60% accurate), a computed tomography (CT) Scan (expensive and involves radiation), and exploratory surgery or endoscopy (expensive and invasive). In short, True Bearing is offering a better test addressing a large, existing market.

How are you differentiated from your key competitors?

True Bearing is offering a tool that is not yet available to doctors prior to CT Scan and/or Exploratory surgery. We will provide the healthcare system with a lower risk – non-invasive blood test allowing for more efficient and accurate addressing of patients with potential infection. We offer This is not yet possible.

What key milestones will you achieve over the next two years?

Over the next two years, True Bearing Diagnostics will 

1.) set up a lab at JLabs which is independent of GWU.

2.) initiate the FDA Clearance process starting with the PreSub (Qsub) meeting with the FDA.

3.) complete the IRB(s) and start sample collection for the FDA Clearance Study

4.) develop relationships with Payers and CMS so that we will be efficiently enabled to commercialize and have insurance coverage post FDA Clearance.