Frequently Asked Questions – FAQ’s

In our bodies we have more than 100 trillion microbes, including bacteria and viruses, outnumbering our normal cells by up to 10 to one. In fact, if you look at the genes in our bodies, we are only about 1% human, as most of our DNA is either bacteria or viral.

For 3 billion years, microbes were our planet’s sole owners, creating our biosphere, maintaining global cycles involving carbon, nitrogen, sulfur, phosphorus, and other nutrients. They not only made all the soil, they set the conditions for the evolution of multicellular life, meaning plants and animals, including us. They used all that time to evolve and diversify their genetic pool to adapt to the most extreme conditions and build strong resilience.

The notion that most bacteria, or germs, are intrinsically bad is widespread. But that view is wildly incorrect. In fact, our planet is run by and for these invisible microbes. New methods of studying the microbial world reveal that most of the bacteria we encounter on a daily basis, and those that reside in and on our bodies, are essential for keeping us alive.

We need to shift our thinking away from human-centric to planet-centric. Microbes were present when humans started emerging. We had to adapt and learn to thrive in a microbial world, and, in fact, microbes ended up being an essential part of human health.

Bacteria and viruses aid in digestion, and they help us exist as humans producing or delivering essential elements to our health, including some of our most precious vitamins. What we’re now learning is that they actually have a tremendous impact on many other aspects of physiologies, such as our skin health, oral health, and mental health. They even assist in actively fighting many diseases. All of this is thanks in part to our exposure to them in our earliest years when they assisted in training our immune system to recognize what needs to be protected  versus what is foreign and should be fought with our inflammatory responses.

Until recently, tissue and blood were believed to be microbe free unless infected. There is now evidence that they too have a microbiome, leading to essential innovations in diagnosis and treatment of disease.  

Until recently, tissue and blood were believed to be microbe free, unless infected (ex. sepsis). But, what has been discovered is that tissue also has a microbiome, with very specific signatures that can sometimes even be shed into the blood. This is even true for cancer tissues. For example, lung cancer tissue will have a different microbial signature than adjacent healthy tissue and a very different microbial signature than breast cancer tissue. Our discovery of this highly differentiated microbial code in the tissue and in blood enabled us to develop the patent pending Oncobiota™ diagnostic platform designed to accurately diagnose cancers early, using only a simple blood draw.

Combining our team’s extensive knowledge of the microbiome with the use of machine learning and bioinformatics, we created the patent pending Oncobiota™ platform that only requires a patient blood sample. We will use this platform technology to query a multitude of microbes to derive a more sensitive and specific identification of the presence of cancer in a given patient, rather than targeting mutations of the cancer itself.

The advantage of this method is that we do not rely on the tumor to reach a certain size to be able to detect a signal. Our method has many levels of amplification of the signal; 1) These microbial biomarkers are abundant in nature, much more than the number of tumor mutations detected in other methods, 2) Their absence can be as informative as their presence, and 3) The microbes involved do not necessarily come from the tumor(s). Some may be recruited by the host to go “defend” itself against the cancer and can be picked up by Oncobiota™ in the blood on their way to the tumor.

Traditional liquid biopsy requires a tumor of significant size to enable enough material to transfer into the bloodstream for detection. This is not the case for circulating microbial signatures associated with cancer. This technology allows for great sensitivity and specificity, independent of tumor size, and thus can enable earlier detection. We hypothesize the signal we observe using our microbiome-driven liquid biopsy™ is not only coming from the tumor, but could also be the host engaging a microbial reaction toward the cancer in an attempt to trigger immune reactions. Importantly, the signal we are analyzing is not only indicating the presence of microbial signatures, but also the absence of some of these signatures when it is compared to healthy patients or even other non-cancer diseases (such as granuloma in the case of lung cancer detection application). Our knowledge of this rich, diverse microbial community amplifies our understanding of how to detect cancer, even in its earliest stages.

Our microbiome-driven liquid biopsy™ method is going through further validation studies and is not yet FDA approved for cancer diagnosis.  It will be available to our collaborators in the near-term as a Research Use Only (RUO) method.

Shortly, following a robust method validation that we are in the process of completing, we will be offering our patent pending Oncobiota™ to all clinicians as a CLIA certified LDT service by late 2022. Clinicians will be able to send us blood samples to be processed in our facility and we will generate a report for them indicating the likelihood of cancer presence in their patients.

Lung cancer is among the most prevalent–with 228,000 new cases in the U.S. in 2020–but has one of the lowest overall survival rates. About 75% of cases are discovered in late stages where the five-year survival rate is only 15%. We will pursue our assay development one cancer at a time, starting with the most common and deadly.

Multi-cancer liquid biopsy, multi-cancer early detection (MCED) or pan-cancer screening has been receiving some buzz lately, and the obvious attraction is the assumption that a pan-cancer screening would save millions of lives. While interesting in theory, and even part of the original discovery work behind Micronoma’s published work in Nature March 2020, early screening for multiple types of cancer at once may not be that ideal in practice- and the reason that Micronoma’s path to clinical adoption is one cancer type at a time. MCED can result in overdiagnosis of cancers due to a high false-positive rate or for some cancer types, it can miss the cancer in the earlier stage of the disease. There’s also the question of how to determine where and what type of cancer has been detected? We must also consider together the stress to patients that a false positive or too early of a diagnosis could cause, and the path to unnecessary treatments. The end result is not more lives saved, but more resources wasted, more side effects from unneeded treatment, and the subsequent stress and fall out from a cancer diagnosis. For now, rather than putting people through stressful and costly screenings with no proven success rates, a better, more efficacious approach, and the one Micronoma stands behind, is to take on cancer one type at a time. For more info on this topic, see our blog, The Case for Tackling One Cancer at a Time or the articles Pan-Cancer Screening: A Dream or a Nightmare by Dr. Margaret Tempero in the Journal of the National Comprehensive Cancer Network or A Look Ahead at Pan-Cancer Testing: Big Unknowns, Great Debates, and Key Questions Facing the Future of the Field, in Diagnostic World News.

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No diagnostic solution should be considered the silver bullet. Clinicians will rarely be able to get a full answer based on only one approach, whether it is imaging, tissue biopsy, or liquid biopsy. To this point, some physicians have reported that between 20-40% of tissue biopsies for NSCLC (non-small cell lung cancer) return inconclusive due to insufficient tissue quantity. So, we would initially like to complement existing diagnostic methods. Our goal is to offer a method that enables at-risk patients (say, smokers) to be detected earlier, or patients with suspicious imaging to be able to utilize Micronoma’s assay to help determine if they are facing a benign or malignant situation.