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ADVANCING ORAL & SYSTEMIC HEALTH

Our mission is to give clinicians what they want: an inexpensive test focused on the five high-risk bacteria that is easy to read and comprehend, effortless to order, and results retuned in 48 hours.

MEET THE PATHOGENS

Aa - Direct Diagnostics

Aa

Aggregatibacter actinomycetemcomitans

Primary cause of rapid alveolar bone loss in both children and adults, severe periodontitis and dental implant failure. Research studies have shown this pathogen increases risk for Cardiovascular Disease, Ischemic Stroke, Brain Abscesses, & Heart Infections

Pg - Direct Diagnostics

Pg

Porphyromonas gingivalis

Primary cause of alveolar bone loss, periodontitis and implant failure. Research studies have shown this pathogen increases risk for Heart Attack, Ischemic Stroke, Type Two Diabetes, Dementia, Alzheimer's Disease, and other inflammatory diseases.

Td - Direct Diagnostics

Td

Treponema denticola

Primary cause of periodontitis and implant failure (peri-implantitus). Recent studies have also demonstrated its association with Dementia and Alzheimer's Disease.

Tf - Direct Diagnostics

Tf

Tannerella forsythia

Primary cause of periodontitis and implant failure (peri-implantitus). It's effect on other health issues is not as well known.

Fn - Direct Diagnostics

Fn

Fusobacterium nucleatum

Associated with periodontitis and implant failure. Among the systemic issues is that it has been associated with preterm birth, low birth weight babies, and fetal death. This pathogen tends to facilitate the movement of other oral pathogens into the circulatory system.

Periodontitis - Direct Diagnostics

NOT JUST ABOUT PERIODONTITIS

All five pathogens have been implicated in Peri-implantitis - inflammation of the soft tissue and bone loss that can lead to implant failure.

HIGH RISK PATHOGEN TEST

  • Easy to describe, explain, and market to the patient

  • Order via our user-friendly online provider portal

  • Fast medical history checkbox

  • Collect 1ml of patient saliva

  • Place in sealed container

  • Schedule FedEx pick-up

  • Results in 2 days

  • Share results with patients   [secure and HIPAA compliant]

  • Implement treatment plan

  • Retest to ensure success

  • Accurate and easy to understand result ranges

  • Key thresholds for optimal health

  • Pathogen descriptions with medical relevance

“80% of American adults over 35 have some form of Gum Disease.” 

“Oral bacteria have been implicated in the development of Alzheimer's disease and dementia.”

“People with gum disease are nearly twice as likely to suffer from heart disease.” 

STAY CONNECTED

Saving Teeth. Saving Lives.

What Clinicians Are Saying About HR5

WHY TEST?

FOCUSED

  • Scientific evidence has shown that these five bacterial pathogens are the most critical and highest risk for infection, inflammation, oral cavity damage, systemic consequences.​

  • Focus makes the HR5 test easier to explain and market to patients, thereby increasing its use in the clinic.​

  • As an efficient screening test, HR5 identifies low grade infections long before they present with visual sympthoms.

ACCURATE

  • Accuracy starts with the latest qPCR technology but wins based on the molecular biochemistry skills of the scientific team and  the superiority of the primers, probes, and signals.​

  • We offer the most accurate test (lowest limit of detection) available for these bacteria in saliva. Ask us about it.​

  • Accuracy means we find these harmful pathogens early, making them easier to treat and driving successful outcomes faster.

AFFORDABLE

  • Price matters to all of us. A lower price-point means that it is easier to market to patients, offers more margin for practices, and increases use which will drive treatments and healthier patients.​

  • We achieved lower cost through focus as well as technology improvements in throughput and operational efficiency​

  • Our goal is to see this test one day covered by medical and dental insurance due to its significant impact on overall health.

EASY

  • For providers and patients alike, easy is about as important as price. Easy to order. Easy to read. Easy to explain. Easy to say yes.​

  • What could be easier than collecting just 1ml of saliva from a patient. Hyper-efficient and results returned in just two days.​

  • Equally important to us is designing the result format to be easy to understand and clearly identify the healthy ranges for each bacteria based on the latest research publications.

COMPELLING

  • The verdict is in and the scientific research continues to implicate these five bacteria in an expanding horizon of oral and systemic health issues - acute and chronic.​

  • Perhaps most compelling is the personalized treatment plan that can be created for each patient to manage their pathogen levels.​

  • Our unique HR5 test can empower your practice to join the conversation for the evolving field of Oral-Systemic Health.

The Red Complex bacteria plus Fn (Aa, Pg, Tf, Td, Fn) at the Keystone pathogens that are most frequently mentioned as contributors to all Chronic Inflammatory Diseases including CVD, IS, DM, Cancers, Alzheimers's, etc. 

-Dr. Tom Nabors

YALE SCHOOL OF PUBLIC HEALTH VERIFIED HR5 WITH 100% ACCURACY

Direct Diagnostics, as a transparent, science-based organization, recently submitted our HR5 test—the most accurate test available for bacteria in saliva, with the lowest limit of detection—to the Yale School of Public Health for verification purposes. Yale is one of the top salivary diagnostic testing programs in the world, and their results were astoundingly conclusive: the limit of detection (LOD) of HR5 qPCR was verified by the SalivaDirect Initiative, Yale School of Public Health. The results showed an unparalleled 100% level of accuracy, which is a result we are very excited to see and share. 

©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

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