Open Site Navigation

Meet Direct Diagnostics

Updated: Jan 12

Can diagnostics direct the course of treatment? Yes, it absolutely can!


The mouth is host to a world of information. The data contained in saliva is ripe for extraction and analysis. Direct Diagnostics is a clinical laboratory and biotechnology company that is advancing the field of molecular testing and driving the evolution of salivary diagnostics. Our team has developed and continues to develop the premier platform for salivary testing.


We are developing the next generation of saliva tests for infectious disease and pathogens found in the mouth and periodontia. The scientific community has produced numerous studies about the destructive outcomes associated with high levels of specific bacteria in the mouth that are detrimental to the whole body and not just oral health. This scientific proof demonstrates the oral systemic connection. This connection means that diagnostics direct the course of treatment.


We align our methods with the principles and goals of The American Academy for Oral Systemic Health (AAOSH) and The BaleDoneen Method.

The American Academy for Oral Systemic Health is a non-profit organization of healthcare leaders and health professionals spreading awareness of the oral systemic health connection.


Dr. Amy Doneen and Dr. Bradley Bale were the first to publish the BaleDoneen Method and show the connection between oral bacteria and heart disease. The BaleDoneen Method is a science-based methodology that is medically proven and accepted to both prevent and reverse heart attacks, strokes, and many other chronic conditions such as type 2 diabetes, dementia, kidney disease, and erectile dysfunction to name a few. This method is focused on the specialty of arteriology. BaleDoneen is the first major publication to show the connection between oral bacteria and heart disease.


The founder of Direct Diagnostics is a forefather of oral systemic health research and practice


Dr. Tom Nabors has been at the forefront of the oral systemic health movement for over 45 years. He is the founder of the first CLIA & CAP certified laboratory that uses DNA-PCR testing for both general and oral medicine. His professional efforts have been focused on the role of oral pathogenic bacteria and their destructive effects. He founded Oral DNA Laboratories and is their former Chief Dental Officer. He is the founder of Direct Diagnostics and continues his work, advancing salivary diagnostics and research of oral pathogenic bacteria. He is a restorative dentist and the recipient of The American Academy for Oral Systemic Health’s lifetime achievement award for his contributions to the field of oral pathogen research and oral systemic health.


Dr. Tom Nabors’ career consists of many firsts in his field. He is the first Dentist to go through the Bale/Doneen Preceptorship Program. Together with Dr. Bradley Bale and Dr. Amy Doneen, presented the first program for AAOSH and introduced the science behind saliva testing using DNA-PCR testing. He is the first dentist to bring a European DNA laboratory to the United States in order to harness the power of genetic and oral pathogen testing.


He believes that most forms of periodontal diseases can be cured. However, traditional medicine and dentistry does not utilize all the tools available to create this reality. The salivary diagnostics that he has created throughout his career–and continues to create–bridge the gap between traditional medicine and dentistry and true oral systemic health care.

Definitive diagnoses can be obtained from saliva testing, if the understanding of the oral systemic connections is implemented. Oral pathogenic bacteria causes inflammation, which leads to disease. This pathogenic bacteria travels throughout the entire body. These pathways of causation can empower dental and medical professionals and provide superior health to their patients.


And it is not only the diagnosis stage that saliva testing is needed. Salivary diagnostics are also repeated during the course of targeted treatment in order to track the treatment’s progress.


Dr. Nabors has over 40,000 patient records under his belt that support the need for broader adaptation of oral systemic health care. In 2001, he collaborated with a German laboratory in order to use DNA-PCR testing in his practice. And he was the first dentist to use both DNA-PCR testing and phase-contrast microscopy on each and every patient.


Creating a clinical laboratory in the United States, to use for the testing in his practice, he founded Oral DNA Labs in 2008.


Now Dr. Nabors has founded Direct Diagnostics and continues to advance the science supporting oral systemic health protocols.


Leveraging the latest in qPCR technology, we are focused on the rapidly expanding field of oral systemic health. The scientific knowledge we have about the five "high-risk" bacteria that reside in the mouth creates the obvious need for diagnostics such as our proprietary HR5™ saliva test. This easy test is accurate, cost effective, and provides actionable information for dental professionals to create targeted treatment plans for their patients.


Now more than ever, the medical and dental communities are geared to find answers through technology. Most patients are unaware that these advanced medical diagnostics are available through their dentists. Your healthcare team is the conduit of information, teaching your patients to request these techniques of diagnosis.


Our initial saliva test for the oral systemic arena is a unique pathogen test focused on known, high risk bacteria. This test represents the most current scientific data relative to specific oral pathogens that cause both periodontal disease and systemic inflammation, which is the primary cause of many other life-threatening diseases.


Here are 10 Reasons to use our HR5 saliva test:​

  • Focused

  • Affordable

  • Accurate

  • Quantitative

  • Patient Friendly

  • Provider Friendly

  • Easy to Read

  • Fast Turnaround

  • User-friendly Software

  • Saliva (just saliva)

Both dental and medical practitioners can take advantage of this test and its results to create an accurate diagnosis and personalized treatment plan for each patient. Early detection, identification, and successful treatment of these specific pathogens will lead to improved whole body health.


When it comes to COVID testing, is saliva superior?

Rapid Saliva-based SARS-CoV-2 Virus Test

With COVID-19 and its continuing variants, displaying substantial staying power, the need for effective, easy to use, repeatable testing is significant. In the early days of SARS-CoV-2 test creation, nasopharyngeal swabs were assumed to be superior due to their reputation in testing other upper respiratory pathogens. The supply chain to support these tests as their demand exponentially increased collapsed under the strain. This break in the system created an urgent need for an alternative.


Passive saliva collection clearly eliminates the discomfort of a nasopharyngeal swab. Saliva testing for COVID-19 is easy, painless, and quick.


Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) testing, which is also referred to as nucleic acid amplification testing (NAAT), provides detection of the genetic material inside the SARS-CoV-2 virus, which causes COVID-19 disease.


Because of its magnification of unique genetic sequences of SARS-CoV-2 by more than a million-fold, PCR is believed to be the most reliable method for COVID-19 testing.


Antigen testing for COVID-19 is yet another testing method. This option identifies proteins on the surface of the COVID-19 virus. However, without these proteins being amplified, this particular testing method tends to provide more “false negatives”, since it is not as sensitive.


Another testing option for COVID-19 diagnosis is Antigen testing, which quickly detects proteins on the surface of the COVID-19 virus. The proteins that are measured are not amplified, therefore these tests are typically less sensitive than PCR, meaning “false negatives” are more likely.


The SalivaDirect™ protocol by Direct Diagnostics is authorized by the FDA under Emergency Use Authorization.


Research performed by Yale University concluded that saliva yielded greater sensitivity and consistency throughout the course of infection over existing nasal swap or nasopharyngeal.1


What are the High Risk 5?

We now have scientific data that connects five specific, high risk oral bacteria to an extensive list of serious health issues. These pathogens wreak havoc in the mouth and throughout the entire body. The following is a brief, non-exhaustive list of the HR5 and the conditions they are associated with.


Aggregatibacter actinomycetemcomitans (Aa)

  • Endocarditis

  • Abscesses

  • Rheumatoid Arthritis

  • Alzheimer's Disease

  • Atherosclerosis

  • High blood pressure

  • Cancer

  • Adverse Pregnancy Outcomes


Porphyromonas gingivalis (Pg)

  • Rheumatoid Arthritis

  • Kidney Disease

  • Multiple Sclerosis

  • Artery Plaque

  • High blood pressure

  • Diabetes

  • Atherosclerosis

  • Alzheimer’s Disease

  • Cancer

  • Gut Dysbiosis

  • Adverse Pregnancy Outcomes


Treponema denticola (Td)

  • Diabetes

  • Artery plaque

  • Joint replacement

  • High blood pressure

  • Alzheimer’s Disease

  • Adverse Pregnancy Outcomes

  • Kidney Disease

  • Atherosclerosis

  • Feeds off of stress

Tannerella forsythia (Tf)

  • Artery Plaque

  • Alzheimer’s Disease

  • Joint replacement

  • Heart attack

  • Cancer

  • Adverse Pregnancy Outcomes

  • Diabetes

  • High blood pressure

  • Atherosclerosis

  • Kidney Disease

Fusobacterium nucleatum (Fn)

  • Preterm birth

  • Pre-eclampsia

  • Low birth weight

  • Artery plaque

  • Atherosclerosis

  • Increases permeability of the vessel walls

  • Enables for other bacterial infection

  • Adheres to and invades endothelial cells

  • Cancer

  • Gut Dysbiosis

As you can see by the heavy hitters contained in this list, the destructive potential of these bacteria is extensive.


With just 1ml of saliva, our HR5 saliva test produces precise results, identifying the presence of the five bacteria considered to be the highest risk pathogens for periodontitis, and systemic inflammation: Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Treponema denticola (Td), Tannerella forsythia (Tf), and Fusobacterium nucleatum (Fn).


In addition to our clinical laboratory services, Direct Diagnostics provides ongoing education and consultative services to create an effective model for practice onboarding, discussing these tests with patients, improving case acceptance, and delivering effective treatment results.


Our CLIC Certified laboratory for salivary diagnostics


Paratus Diagnostics - clinical laboratory and biotechnology company

Our high-complexity CLIA certified lab provides efficient and crucial salivary diagnostic testing solutions to healthcare providers and patients throughout the United States. Located in Central Texas, our lab is able to reach an ample customer base. The design of our HR5 saliva test is optimized for efficient, affordable, accurate results.


Paratus Diagnostics is our technology group. They are providing high quality, precise results with their point of care diagnostic devices.


Beyond our flagship HR5 saliva test, our COVID SalivaDirect™ test, in partnership with Yale University, proved that saliva-based infectious disease testing is not only possible, but optimal.


Our Incredible, oral systemic health focused team

"Today, we have made DNA testing the Gold Standard for a true medical diagnosis. This allows for a personalized treatment plan with the goal of healing all periodontal infections, determining risk for many chronic systemic diseases, and making sure that the mouth is not a contributor to chronic systemic inflammation.” - Dr. Tom Nabors

Direct Diagnostics is led by a Board of Directors and Management Team with decades of laboratory, scientific, healthcare, and business experience.


Click here to learn more about our incredible team.


Oral systemic health methods are more sophisticated than conventional medicine

"Reducing sources of oral inflammation is a cornerstone of my patient care. We believe in providing patients all the diagnostics available to make sure their oral health is optimal. The link between oral and systemic health is well documented, and it is important to obtain a full picture of what is going on in the mouth. Using salivary diagnostic testing and incorporating inflammatory blood panels are just a part of our patient care protocol." - Barbara McClatchie, DDS

Traditional dentistry often examines your mouth by just probing and what they can see. Oral systemic healthcare teams use the power of diagnostics to obtain definitive data and create a targeted treatment plan.


Saliva diagnostic testing that searches for any presence of pathogenic bacteria is available and precise. Saliva testing effectively identifies any adverse factors in gum and bone health. These are powerful tasks in the battle against periodontal disease.


It’s not just the discovery of oral pathogens being present in the mouth that is important. It is crucial to identify the specific type of bacteria that we’re dealing with. Specific bacteria have been scientifically proven to be associated with specific diseases. These direct correlations have been established through scientific research. The list of issues attached to these correlations include cardiovascular disease, pregnancy complications, diabetes, Alzheimer's disease, cancer, and more.


Our founder, Dr. Tom Nabors is one of the forefathers of the oral systemic movement. He has lectured about his groundbreaking work to hundreds of audiences. These speaking engagements have taken place in almost every state in America as well as internationally, and spanned many venues and universities, such as Cleveland Clinic, Vanderbilt, Temple, and Harvard. His quest for new scientific discoveries in the oral systemic health field continues today.


Our technology group, Paratus Diagnostics, is creating point-of-care diagnostic devices that can render lab-quality results with convenience and precision.


Working together with oral systemic health care centers and organizations such as The American Academy for Oral Health and BaleDoneen makes Direct Diagnostics an integral component of the oral systemic treatment process.


Our goal is to provide clinicians with the data that they want and need: an affordable test that is focused on the five high risk bacteria and supplies easy to read results. Our saliva test is extremely easy to order and conduct, and the results are available in 48 hours.


Learn more about the power of diagnostics. Start Testing.


Sources:

1. https://www.medrxiv.org/content/10.1101/2020.04.16.20067835v1


©2022 by Direct Diagnostics LLC. Direct Diagnostics is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets the requirements to perform high complexity tests. CLIA Registration 45D2190910. 

Direct Diagnostics is certified under the College of American Pathologists (CAP), CAP Accreditation #9088531

Website by Redwood Designs.

  • Instagram
  • LinkedIn | Direct Dx
  • Facebook
  • YouTube