MyPerioPath & MyPerioID PST

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1 MyPerioPath & MyPerioID PST Clinician s Resources OralDNA Labs Leaders in Advancing Wellness Through Salivary Diagnostics

2 OralDNA Labs Advancing Patient Wellness in Dentistry through Salivary Diagnostics Welcome to the OralDNA Labs Clinician s Resources for Periodontal Disease Testing. The information and tools included in this binder are intended to introduce dental professionals to the concept of salivary diagnostics, provide detailed information about the MyPerioPath and MyPerioID PST tests, and to provide tools that will help you incorporate these tests into your practice. MyPerioPath and MyPerioID PST are two innovative, salivary-based, periodontal disease tests that can be used as part of a patient s overall wellness plan. The salivary sample can be easily collected in about a minute using an oral rinse, and the results provided by OralDNA Labs gives additional information about your patient s oral health. To help you get started, we have prepared ready-to-print letters and other tools (patient brochure, appointment/recall card, website banner, press release, etc.) that you can use to educate and inform patients as well as communicate with other healthcare professionals and local media. These tools will help you get the word out that the MyPerioPath and MyPerioID PST salivary diagnostic tests are now available at your office.

3 Table of Contents The Role of Salivary Diagnostic Testing in Patient Wellness MyPerioPath and MyPerioID PST Tests Interpreting Test Results Tools to Help You Incorporate OralDNA Tests into Your Practice

4 1 1 Wellness The Role of Salivary Diagnostic Testing in Patient Wellness

5 The Role of Salivary Diagnostic Testing in Patient Wellness This section includes an overview of periodontal disease and takes a look at the traditional model for periodontal disease diagnosis and management. Also included is a discussion about the impact of incorporating salivary diagnostic tests into periodontal disease diagnosis and management. Incorporation of these tests into your practice will enhance the way you diagnose and manage your patients with periodontal disease. 1.1 OralDNA Labs Clinician s Resources

6 Periodontal Disease Overview Prevalence of Periodontal Disease in the U.S. Prevalence of gingivitis, the more common but less severe form of periodontal disease, is determined based on the presence of gingival inflammation and bleeding. According to data from the National Health and Nutrition Examination Survey (NHANES) III, about 50% of Americans have gingival bleeding. 1 Prevalence data for periodontitis, the more severe form of periodontal disease, vary widely according to age of the individuals in the study population, the criteria used to define periodontitis, and the method used to examine the individuals (eg, partial-mouth vs full-mouth examination). In general, moderate periodontitis affects 30% to 50% of adult Americans, and 5% to 15% have severe periodontitis

7 Periodontal Disease Overview The Perio-Systemic Link: Mouth, Body, Overall Health Currently, it s difficult to accurately predict which patients are at greatest risk of progressing to severe disease and which patients will be non-responsive to standard periodontal scaling, root planing, and debridement, complicating development of an optimal, patient-specific treatment plan. Risk and prognosis of periodontal disease is affected by multiple factors. 3,4 Underlying pathogen(s) Genetics: based on family and twin studies and some cytokine studies (eg, interleukin 1) Lifestyle factors: tobacco use, stress, teeth grinding or clenching, poor nutrition Co-morbid conditions: diabetes, cardiovascular disease, rheumatoid arthritis, osteoporosis/osteopenia, obesity, pregnancy Medications: long-term corticosteroids, calcium channel blockers, phenytoins, immunosuppressants, chemotherapeutics Periodontal disease, in turn, affects other health conditions. Treatment of periodontal disease helps patients control their diabetes. 5,6 Periodontal disease may be a risk factor for heart disease. 7-9 The underlying nature of these associations is still being investigated, but the periodontal pathogens and increased inflammation may be involved. For example, periodontal disease, diabetes, cardiovascular disease, and rheumatoid arthritis are all inflammatory conditions. Additionally, some small studies have found periodontal pathogens in atheromatous plaques Regardless of the underlying mechanism, it s clear that periodontal disease is linked to overall health. Additional information can be obtained from the American Academy of Periodontology. 1.3

8 Periodontal Disease Overview References 1. Albandar JM, Kingman A. Gingival recession, gingival bleeding, and dental calculus in adults 30 years of age and older in the United States, J Periodontol. 1999;70: Burt B, Research, Science, and Therapy Committee of the American Academy of Periodontology. Position paper: epidemiology of periodontal diseases. J Periodontol. 2005;76: Krebs KA, Clem DS III. Guidelines for the management of patients with periodontal diseases. J Periodontol. 2006;77: HealthPartners Dental Group and Clinics guidelines for the diagnosis and treatment of periodontal diseases. Minneapolis (MN): HealthPartners; 2006 Mar p. Summary available at: guidelines.gov/content.aspx?id=10803&search=periodontal+disease. Accessed January 19, Koromantzos PA, Makrilakis K, Dereka X, et al. A randomized, controlled trial on the effect of nonsurgical periodontal therapy in patients with type 2 diabetes. Part I: effect on periodontal status and glycaemic control. J Clin Periodontol. 2011;38: Simpson TC, Needleman I, Wild SH, et al. Treatment of periodontal disease for glycaemic control in people with diabetes (Review). Cochrane Database Syst Rev. 2010;(5):CD Bahekar AA, Singh S, Saha S, et al. The prevalence and incidence of coronary heart disease is significantly increased in periodontitis: A meta-analysis. Am Heart J. 2007;154: Humphrey LL, Fu R, Buckley DI, et al. Periodontal disease and coronary heart disease incidence: A systematic review and meta-analysis. J Gen Intern Med. 2008;23: Stein JM, Kuch B, Conrads G, et al. Clinical periodontal and microbiologic parameters in patients with acute myocardial infarction. J Periodontol. 2009;80: Haraszthy VI, Zambon JJ, Trevisan M, et al. Identification of periodontal pathogens in atheromatous plaques. J Periodontol. 2000;71: Fiehn NE, Larsen T, Christiansen N, et al. Identification of periodontal pathogens in atherosclerotic vessels. J Periodontol. 2005;76: Padilla C, Lobos O, Hubert E, et al. Periodontal pathogens in atheromatous plaques isolated from patients with chronic periodontitis. J Periodontal Res. 2006;41:

9 Periodontal Disease Diagnosis and Management Traditional Model Diagnosis is primarily based on clinical symptoms and medical history. The patient s response to treatment is measured by observing changes in clinical symptoms such as inflammation, pocket depth, etc. Enhanced Model: Addition of Salivary Diagnostic Tests Salivary diagnostic tests allow you to 1. Identify bacterial targets of therapy 2. Set new goals for therapy 3. Identify patients who might have an increased genetic risk of progression to severe disease DNA testing that targets periodontal pathogens can accurately identify the bacteria that are likely triggering the inflammatory response and precipitating a particular patient s clinical symptoms. DNA testing thus identifies the bacterial target(s) for therapy. 1 Monitoring the concentration of these pathogens during therapy may help establish the therapy endpoint. 1 DNA tests can also determine the presence of certain interleukin 1 (IL-1) genetic variations associated with chronic, but not aggressive (previously called early onset), periodontal disease. 2 Prevalence of these polymorphisms varies according to ethnicity. For example, prevalence of a composite genotype (IL1A G4845T and IL1B C3954T) is 35% in Caucasians but only 2% in those with a Chinese ancestry. 3,4 The scientific community has yet to reach consensus regarding the clinical use of this genotypic information. 1.5

10 Periodontal Disease Diagnosis and Management References 1. Armitage GC, Research, Science, and Therapy Committee of the American Academy of Periodontology. Diagnosis of periodontal diseases. J Periodontol. 2003;74: Nikolopoulos GK, Dimou NL, Hamodrakas SJ, et al. Cytokine gene polymorphisms in periodontal disease: a meta-analysis of 53 studies including 4178 cases and 4590 controls. J Clin Periodontol. 2008;35: Lang NP, Tonetti MS, Suter J, et al. Effect of interleukin-1 gene polymorphisms on gingival inflammation assessed by bleeding on probing in a periodontal maintenance population. J Periodont Res. 2000;35: Armitage GC, Wu Y, Wang HY, et al. Low prevalence of a periodontitis-associated interleukin-1 composite genotype in individuals of Chinese heritage. J Periodontol. 2000;71:

11 2 2 Tests MyPerioPath and MyPerioID PST Tests

12 MyPerioPath and MyPerioID PST Tests This section describes the MyPerioPath and MyPerioID PST tests. It also tells you how to administer the tests. 2.1 OralDNA Labs Clinician s Resources

13 MyPerioPath and MyPerioID PST Tests What are the MyPerioPath and MyPerioID PST tests? These 2 tests are molecular tests that begin with extraction of DNA from the patient s saliva. This DNA is amplified via polymerase chain reaction (PCR). Specific dyes (beacons) are then used to detect and quantify bacteria that cause periodontal disease (MyPerioPath) or genetic information associated with periodontal disease risk (MyPerioID PST). Table. Targets of the MyPerioPath and MyPerioID PST Tests MyPerioPath Aggregatibacter actinomycetemcomitans Campylobacter rectus Capnocytophaga species (gingivalis, ochracea, sputigena) Eikenella corrodens Eubacterium nodatum Fusobacterium nucleatum/periodonticum Parvimonas micra Porphyromonas gingivalis Prevotella intermedia Tannerella forsythia Treponema denticola MyPerioID PST Interleukin 1 alpha (IL1A) polymorphism (G4845T) Interleukin 1 beta (IL1B) polymorphism (C3954T] 2.2

14 MyPerioPath and MyPerioID PST Tests The MyPerioPath test can give oral health professionals supplemental information about a patient s periodontal disease. It provides semi-quantitative levels of 11 periodontal pathogens. Identification of these pathogens can help guide development of a patient-specific treatment plan and help establish the therapy endpoint. Although the test can be used for any patient who has a periodontal infection, it may be especially useful in patients with either refractory chronic periodontal disease or aggressive periodontal disease. The MyPerioID PST test detects genetic variations that have been associated with chronic, but not aggressive (previously called early-onset), periodontal disease. The scientific community has yet to reach consensus regarding the clinical use of this genotypic information. Molecular testing has already dramatically improved diagnosis in the medical arena. Now, oral health professionals and their patients can also benefit from this technology. How to Administer the MyPerioPath and MyPerioID PST Tests Administering the test is easy and involves the following steps: 1. Patient vigorously swishes with a saline solution for 30 seconds. 2. Patient expectorates into a funneled collection tube. 3. Remove funnel; secure cap to top of collection tube. 4. Ship samples at room temperature to OralDNA Labs using the pre-paid FedEx envelope. 5. OralDNA Labs generates an electronic report in a secure, online Web portal and sends an notification to you within 4-5 business days of sample receipt. 2.3

15 3 Interpreting Test Results 3 Results

16 Interpreting Results This section includes a sample of the test report for both the MyPerioPath and MyPerioID PST tests. To assist you in understanding the report, we have assigned a number to each section of the report and have provided a detailed description of each numbered section. 3.1

17 MyPerioPath Report Understanding MyPerioPath Report, Pg. 1 BACTERIAL PROFILE Patient demographic information 2. Summary of test results; a. A positive result indicates presence of bacterial pathogens above the threshold level b. Bacterial Risk : risk of disease progression based on specific bacterial pathogens 3. Graphic representation of specific pathogen results 4. Pathogen Load Threshold : The concentration above which patients are generally at increased risk of attachment loss/disease progression (represented by the black lines) 5. Specific pathogen results: high result indicates pathogen is present at concentrations above the threshold; low result indicates pathogen is present at concentrations below the threshold 6. Clinical Significance : information describing the typical clinical impact the pathogen has on periodontal disease 3.2

18 MyPerioPath Report 7 CLINICAL CONSIDERATIONS Understanding MyPerioPath Report, Pg. 2 CLINICAL CONSIDERATIONS Patient demographic information 8. Summary and graphic presentation of test results 9. Therapeutic options based on patient s pathogen profile (ie, which pathogen(s) are present and at what concentration) 10. Recommendation for follow-up testing 11. Summary of patient clinical information at time of the test 12. Links to additional information at MyOralDNA.com

19 MyPerioID PST Report Understanding MyPerioID PST Report Patient demographic information 2. Result summary: positive indicates that a relevant polymorphism was detected 3. Patient s IL-1 genotype 4. Interpretation of the genotype results 5. Clinical significance of the test result 6. Additional information about the association of IL-1 polymorphisms with periodontal disease risk 7. Additional clinical and lifestyle factors that may affect patient s overall risk 7 3.4

20 4 Creating Awareness 4 Awareness

21 Resources to Educate and Inform This section describes the tools OralDNA Labs provides to make it easy for you to let your community know that you are now offering the MyPerioPath and MyPerioID PST tests. These tools include: Letter to periodontists announcing test availability Letter to periodontist for patient referral Letter to patients announcing test availability Letter to patient with positive test result Letter to primary care physician or cardiologist announcing test availability Letter to patient to determine interest in testing Website banner ad Patient appointment/recall card Patient release form Press release Patient awareness counter poster Patient education pamphlet Of course, as you know, a personal telephone call is a very effective way to communicate with your colleagues. These resources can be used to support such conversations either before or after the call. OraDNA Labs values your commitment and dedication to your patients, which is why we would like to hear what you have to say. Please feel free to provide suggestions on additional resources you feel are needed to help you communicate with your specialists and patients regarding periodontal disease and the MyPerioPath and MyPerioID PST tests. Simply us at support@oraldna.com. As additional tools are developed, you will be notified through of their availability and how you can retrieve them via the web. 4.1

22 Letters How to use: Dear Dr. <Name of Periodontist>: In an effort to more accurately and definitively diagnose patients with periodontal disease, our office is now incorporating two salivary DNA diagnostic tests MyPerioPath and MyPerioID PST for patients demonstrating signs and symptoms of periodontal disease. Developed by OralDNA Labs, the MyPerioPath test identifies the periodontal pathogens that may be precipitating a patient s clinical symptoms. Test results include the type and concentration of disease-causing bacteria; a patient-specific, bacterial-related risk of disease progression; and suggestions for suitable antibiotic therapy. The MyPerioID PST test assesses a patient s genetic risk of having periodontal disease and his/her genetic risk of progression. The risk assessment is based on the presence or absence of certain polymorphisms in the patient s interleukin-1 gene. Going forward we will be using these salivary diagnostic tests, along with clinical signs and symptoms, in our assessment. Should I diagnose a patient with moderate to severe periodontal disease that would most appropriately and effectively be treated by a specialist such as yourself, we would like to refer the patient to your office for treatment and provide you with his/her test results. If you have any questions, or would like more information on the salivary diagnostic tests available from OralDNA Labs, feel free to contact me at (XXX)-XXX-XXXX. Best regards, <Your Name Here> The CD that accompanies this material contains 6 letters that can help you communicate about the MyPerioPath and MyPerioID PST tests with your patients, referral periodontists, and other healthcare professionals. These letters are explained in greater detail below. Each letter is in an easy-to-use Word document format. Each document can be customized to include the recipient s name and your name. The letter can then be printed on your office stationery or stationery of your choice. Letter to periodontists to announce test availability (Periodontist_Test_Availability.docx) The purpose of this letter is to inform the periodontists to whom you refer patients that you now use the MyPerioPath and MyPerioID PST tests in your practice. Letter to periodontist when referring a patient who tested positive (Periodontist_Patient_Referral.docx) The purpose of this letter is to notify the periodontist that the patient has tested positive for moderate to severe periodontal disease. The letter could be accompanied by a copy of the patient s test report. Letter to patients informing them of test availability (Patient_Test_Availability.docx) The purpose of this letter is to raise your patients awareness of periodontal disease and inform them of the availability and importance of the MyPerioPath and MyPerioID PST tests. Letter to patient with positive test result (Patient_Positive_ Test.docx) The purpose of this letter is to inform a patient who tests positive for moderate to severe periodontal disease that he/she needs immediate treatment to prevent disease progression. This letter could be accompanied by a copy of his/her test report. Letter to family practitioners and cardiologists to announce test availability (PCP_Cardiologist_Test_Availability.docx) The purpose of this letter is to inform your patient s family practitioner or cardiologist that you have integrated these tests into your practice. Letter to patient to determine interest in testing (Patient_Interest_in_Tests.docx) The purpose of this document is to inform patients about the availability of tests for periodontal disease and oral cancer and to find out if they are interested in taking one or more of the tests. 4.2

23 Website Banner Ad A banner ad on your website is a great way to raise awareness of periodontal disease and inform patients of the availability of the MyPerioPath and MyPerioID PST tests at your practice. The ready-to-use banner ad is included on the CD (WebBanner.jpg). How to use: Have your Information Technology Specialist or Website Administrator add the banner ad to your website. 4.3

24 Patient Appointment/Recall Card It s time for a checkup! We have a seat reserved for you. While you are here, ask about our new periodontal disease tests. Do you use recall cards to remind your patients about their upcoming appointment or to remind them it s time to make an appointment? If you do, you can raise their awareness of periodontal disease and inform them of the availability of the MyPerioPath and MyPerioID PST tests at the same time by using the patient recall card included on the CD. There are two versions on the CD that can be customized with your office information. Your next dental appointment is: at o clock. Be sure to ask about our two periodontal disease tests: MyPerioPath and MyPerioID PST. These tests provide information that helps us treat periodontal infections better than ever. Sample collection is fast and easy: the patient simply swishes a sterile rinse solution in his/her mouth and spits it into a tube. Ask us about the MyPerioPath and MyPerioID PST tests at your next visit. Professional printer version (PtRecallCard_ Professional.pdf) This file is for use by a professional printer. You can bring this to your printer and they can add your office information before printing. Do-it-yourself version (PtRecallCard_Do_It_ Yourself.docx) This file can be customized to reflect your office information and then printed from your own printer. 4.4

25 Patient Release Form PATIENT AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION (PHI) I authorize <name of dental practice> and its employees to use and/or disclose my protected health information as specified in this request. I understand that this authorization will expire on or one year from the date subscribed below, whichever is sooner. Protected Health Information to be Disclosed and Purpose of Disclosure I authorize <name of dental practice> to disclose my complete patient file, which may include but is not limited to the information described below, to any specialist[s] recommended by <name of dental practice> for the purpose of potential involvement by such specialist(s) in my diagnosis and recommended treatment, if any. MyPerioPath test results MyPerioID PST test results OraRisk test results Billing information Patient demographic information (such as name, address, phone number) Dental and Medical Notes/Records/Summary I understand that the information used and/or disclosed pursuant to this authorization may be re-disclosed by the person or party receiving it; in that case, the information may no longer be protected under federal privacy law. Notice to the Patient We cannot condition our provision of services to you on the receipt of this signed authorization; We must provide you with a copy of the signed authorization upon request; You may request a copy of the protected health information to be used or disclosed; This authorization only covers PHI that is used or disclosed by <name of dental practice>. The information could be redisclosed by the person(s) who receive it and, in that case, your PHI will not be protected by the HIPAA privacy and security rules; You have the right to revoke this authorization at any time, provided that you do so in writing by submitting the Patient Revocation to <name of dental practice>, except to the extent that we have already relied on this authorization to use or disclose your information; and You may refuse to sign this authorization. Patient s Information 1. Patient s Name First Name Middle Name Last Name Provide all other names (nicknames, alternate spellings, maiden names, etc.) 2. Patient s Date of Birth: 3. Patient s Address (Street, City, State, Zip): Signature I have reviewed and I understand this Authorization. Since you may want to release your patient s MyPerioPath or MyPerioID PST test results to a periodontist at time of referral, you might need to have the patient sign a release form. We have included a simple form on the CD. The form can be used by the patient to authorize the transfer of test results to your office and other health professionals. How to use: Access the release form on the CD (Patient_Release_Form.docx) Add the name of your dental office where indicated on the form (8 places) Print the form Hand it to the patient and ask that he/she complete and sign the form Name (print) Signed: Date: (Patient) Or by: Date: (Patient's Representative) Description of Representative s Authority: 4.5

26 Press Release Media Contact: <name> Dentist Name, Title Practice Name Phone # Address A pre-formatted, sample press release is included on the CD (Press_Release.docx) accompanying this binder. You will notice that we have left spaces available for you to enter your name and office information to complete the press release. FOR IMMEDIATE RELEASE: A press release sent to your local media contacts will raise awareness of periodontal disease and the tests available for it. Better still, it positions your dental practice as a leader in the field. At the media s discretion, the press release will appear in print for the public to read. It allows people to become aware of the accessibility and importance of the MyPerioPath and MyPerioID PST tests. 4.6 LOCAL DENTIST NOW USING SALIVARY DNA TESTS TO FIGHT PERIODONTAL INFECTIONS City, State Month, Date, Year <Town> dentist Dr. <Name>, whose practice is located at <Street Address>, is now administering two molecular tests that provide supplemental information about a patient s periodontal disease. This information can be used to develop patient-specific treatment plans for periodontal disease therapy and to help establish the therapy endpoint. The two salivary diagnostic tests, named MyPerioPath and MyPerioID PST, are offered by OralDNA Labs Inc., a subsidiary of Quest Diagnostics. Specifically, the MyPerioPath test provides semi-quantitative levels of 11 different species of bacteria known to trigger periodontal disease. In addition to identifying the bacterial pathogens, the test provides a bacterial-related risk of disease progression and suggestions for suitable antibiotic therapy. The MyPerioID PST test detects genetic changes (DNA polymorphisms) that have been associated with increased incidence and/or progression of chronic periodontal disease in some studies. According to Dr. <Name>, We are very pleased to be one of the first dental practices in the area to utilize the MyPerioPath and MyPerioID PST salivary diagnostic tests, enhancing our ability to provide the best possible care. Periodontal disease is a chronic inflammatory disease that affects the gum tissue and other structures supporting the teeth. If left untreated, it can lead to tooth loss. Besides helping with tooth retention, successful periodontal treatment can help patients with diabetes to better control their disease. 1,2 About 50% of Americans have gingival bleeding, the more common but less severe form of periodontal disease. 3 Prevalence of more severe disease is more difficult to ascertain. Several research studies have associated gum disease with other chronic inflammatory diseases such as diabetes, cardiovascular disease, and rheumatoid arthritis. 4,5 For more information regarding the MyPerioPath and MyPerioID PST salivary diagnostic tests, or to schedule an appointment, call Dr. <Name> at <XXX-XXX-XXXX> or visit How to Submit the Press Release Target local area newspapers with your release. Pull up the newspaper on the Internet to obtain the name of the appropriate editorial contact. A business editor or assistant editor will be most appropriate, as this is news relevant to your business. This is typically indicated in the contact us or staff section of a newspaper s site. NOTE: While there may be an address, personally contacting an editor is advised. Only your one-on-one, direct conversation can establish a personal rapport. Call the contact and give him/her your pitch (pique his/her interest in the topic so that he/she is encouraged to print it). Typically, socially relevant, timely topics are sought-after content that editors will react favorably to. NOTE: Be friendly, yet aggressive! Editors are extremely busy with tight deadlines on a daily, sometimes hourly, basis. Their pace is often fast and abrupt. They prefer the 10-second pitch that immediately tells them you ve got important, relevant news that s worth their time to read and print. Once you have generated interest, obtain the editor s address and send the document to him/her. Call within two days to see if he/she is interested in using the press release. Continue to or call to nail down a particular date he/she thinks the press release may appear. NOTE: Editors use press releases at their discretion, often extracting specific elements of it for space or content reasons

27 Patient Awareness Counter Poster Patient Education Pamphlet Millions of people have periodontal disease and don t even know it. Could you be one of them? Periodontal disease is often silent, meaning symptoms do not appear until an advanced stage of the disease. The earlier it is detected, the easier it is to treat and the better the outcome. Protect your smile from the harmful effects of periodontal disease. Ask your dental professional about MyPerioPath and MyPerioID PST salivary diagnostic tests today. Ask your dental professional today. The counter poster shipped with this binder can be used to raise awareness of periodontal disease and inform patients of the availability of the tests at your practice. The poster has a sleeve attached to house copies of a patient education pamphlet (orderable separately). The poster should be displayed prominently in the practice. It can be placed on any countertop or table where there is good visibility. To order copies of the periodontal patient education pamphlet, simply contact us through any of the following methods: supplyorder@oraldna.com Phone: Fax: OralDNA Labs. All rights reserved. 4.7

28 Clinician Resources Authorization Thank you for your interest in OralDNA Labs MyPerioPath and MyPerioID PST Clinician Resources. We appreciate your dedication to advancing patient wellness through salivary diagnostics and incorporating these resources into your practice. To ensure that all details regarding the resources have been fully explained and outlined to you and your staff by your OralDNA Clinical Specialist, we would appreciate it if you would complete this form and return it via mail, fax, or . Signature Date OralDNA Labs Headquarters: OralDNA Labs Inc. 214 Overlook Circle, Suite 120 Brentwood, TN OralDNA Labs Fax Number: OralDNA Labs Address:

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