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Evidence

Proven by Science
Backed by Data

Peer-reviewed studies validate the accuracy, clinical utility, and real-world impact of Proove Pain Perception.

View Studies

96%

Population Covered by Haplotype

85%

Physician-Reported Consistency

72%

Improved After Medication Change

Pain Variance Crisis: “Science by Emoji” Is Failing

Proove helps clinicians objectively assess pain to guide improved treatment & outcomes.

N=275

The NRS “may have only modest accuracy for identifying patients with clinically important pain in primary care.”3

N=528

In practice, the NRS is “less accurate than under ideal circumstances.”4

N=300

“The quality of pain care was unchanged before and after the pain initiative… patients who reported substantial pain…had inadequate pain management.”5

Proove Pain Perception®: Clinical Validity Data

We all feel pain differently — four independent, peer-reviewed findings behind the COMT haplotype Proove Pain Perception evaluates.

Human Molecular Genetics

The test accounted for 96% of the population and correlated with sensitivity (p<0.0004) to experimental pain.6

Pain

The test was associated with multiple forms of pain stimuli.7

Science

The test influenced messenger RNA local stem-loop structures, directing downstream protein levels and enzymatic activity.8

Pain

Phenotypes related to sex and psychological stress were associated with pain sensitivity.9

Treatment Impact by the Numbers

Source: Sharma et al., J Psychiatr Res, 2017 (N=134)10

Outcomes After Testing

40%
Treatment Plan Changed
72%
Improved After Med. Change
69%
Improved via Non-Pharma
85%
Physician-Reported Consistency

Treatment Plan Impact

40%
plan changed
  • Treatment plan changed (40%)
  • No change to plan (60%)

Proove Pain Perception®: Clinical Utility Data

Named outcome studies showing what changes when clinicians use Proove Pain Perception results.

In a study of 134 patients, comparing treatment outcomes guided by Proove Pain Perception® versus Treatment As Usual (TAU), over 70% of patients improved with Proove versus TAU within 60 days.10

In a study of 89 patients in an Emergency Department, the haplotype predicted neck pain, headache, dizziness, and physical and emotional recovery following a motor vehicle collision.11

In a study of 40 patients having lumbar spinal surgery, the proprietary haplotype in Proove Pain Perception® was associated with degenerative disc disorder.12

References

  1. [1] Fillingim RB, Wallace MR, Herbstman DM, Ribeiro-Dasilva M, Staud R. Genetic contributions to pain: a review of findings in humans. Oral Dis. 2008 Nov;14(8):673-82. doi: 10.1111/j.1601-0825.2008.01458.x. PMID: 19193196; PMCID: PMC2667226.
  2. [2] Macgregor AJ, Andrew T, Sambrook PN, Spector TD. Structural, psychological, and genetic influences on low back and neck pain: a study of adult female twins. Arthritis Rheum 2004;51:160–167. PMID: 15077255.
  3. [3] Krebs EE, Carey TS, Weinberger M. Accuracy of the pain numeric rating scale as a screening test in primary care. J Gen Intern Med. 2007 Oct;22(10):1453-8. doi: 10.1007/s11606-007-0321-2. PMID: 17668269; PMCID: PMC2305860.
  4. [4] Lorenz KA, Sherbourne CD, Shugarman LR, Rubenstein LV, Wen L, Cohen A, Goebel JR, Hagenmeier E, Simon B, Lanto A, Asch SM. How reliable is pain as the fifth vital sign? J Am Board Fam Med. 2009 May-Jun;22(3):291-8. doi: 10.3122/jabfm.2009.03.080162. PMID: 19429735.
  5. [5] Mularski RA, White-Chu F, Overbay D, Miller L, Asch SM, Ganzini L. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med. 2006 Jun;21(6):607-12. doi: 10.1111/j.1525-1497.2006.00415.x. PMID: 16808744; PMCID: PMC1924634.
  6. [6] Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W. Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. doi: 10.1093/hmg/ddi013. PMID: 15537663.
  7. [7] Diatchenko L, Nackley AG, Slade GD, Bhalang K, Belfer I, Max MB, Goldman D, Maixner W. Catechol-O-methyltransferase gene polymorphisms are associated with multiple pain-evoking stimuli. Pain. 2006 Dec 5;125(3):216-224. doi: 10.1016/j.pain.2006.05.024. PMID: 16837133.
  8. [8] Nackley AG, Shabalina SA, Tchivileva IE, Satterfield K, Korchynskyi O, Makarov SS, Maixner W, Diatchenko L. Human catechol-O-methyltransferase haplotypes modulate protein expression by altering mRNA secondary structure. Science. 2006 Dec 22;314(5807):1930-3. doi: 10.1126/science.1131262. PMID: 17185601.
  9. [9] Meloto CB, Bortsov AV, Bair E, Helgeson E, Ostrom C, Smith SB, Dubner R, Slade GD, Fillingim RB, Greenspan JD, Ohrbach R, Maixner W, McLean SA, Diatchenko L. Modification of COMT-dependent pain sensitivity by psychological stress and sex. Pain. 2016 Apr;157(4):858-867. doi: 10.1097/j.pain.0000000000000449. PMID: 26675825; PMCID: PMC4794347.
  10. [10] Sharma M, Kantorovich S, Lee C, Anand N, Blanchard J, Fung ET, Meshkin B, Brenton A, Richeimer S. An observational study of the impact of genetic testing for pain perception in the clinical management of chronic non-cancer pain. J Psychiatr Res. 2017 Jun;89:65-72. doi: 10.1016/j.jpsychires.2017.01.015. PMID: 28182962.
  11. [11] McLean SA, Diatchenko L, Lee YM, Swor RA, Domeier RM, Jones JS, Jones CW, Reed C, Harris RE, Maixner W, Clauw DJ, Liberzon I. Catechol O-methyltransferase haplotype predicts immediate musculoskeletal neck pain and psychological symptoms after motor vehicle collision. J Pain. 2011 Jan;12(1):101-7. doi: 10.1016/j.jpain.2010.05.008. PMID: 20688576; PMCID: PMC2975044.
  12. [12] Gruber HE, Sha W, Brouwer CR, Steuerwald N, Hoelscher GL, Hanley EN Jr. A novel catechol-O-methyltransferase variant associated with human disc degeneration. Int J Med Sci. 2014 May 15;11(7):748-53. doi: 10.7150/ijms.8770. PMID: 24904231; PMCID: PMC4045795.

Peer-Reviewed Studies & Publications

Clinical Utility & Validation Studies

Clinical Utility

A Prospective, Longitudinal Study to Evaluate the Clinical Utility of a Predictive Algorithm That Detects Risk of Opioid Use Disorder

Brenton A, et al. J Pain Res. 2018;11:119-131.

In 5,397 patients across 100 clinics, physicians used the algorithm to guide treatment for over half of patients, and patients whose treatment was guided by results saw an average pain reduction of 3.4 points on a 1-10 scale.

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Validation

Observational Study to Calculate Addictive Risk to Opioids: A Validation Study of a Predictive Algorithm to Evaluate Opioid Use Disorder

Brenton A, et al. Pharmacogenomics Pers Med. 2017;10:187-195.

Validated the algorithm in 258 patients with diagnosed opioid use disorder and 650 controls, achieving 95.7% sensitivity in identifying high- and moderate-risk patients — sensitivity stayed above 95% even as OUD prevalence varied.

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Clinical Guidelines

Adding Genetic Testing to Evidence-Based Guidelines to Determine the Safest and Most Effective Chronic Pain Treatment for Injured Workers

Meshkin B, et al. Int J Biomed Sci. 2015;11(4):157-165.

Makes the case for incorporating genetic testing into evidence-based chronic pain treatment guidelines for injured workers, given the documented genetic contribution to both pain experience and addiction susceptibility.

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Case Study

A Precision Medicine Approach to a Patient With Unresolved Pain Following Orthopedic Surgery: A Case Report

Gazzaniga D, Brenton A, Meshkin B. J Med Case Rep. 2017;11:50.

A patient previously labeled a “drug seeker” had a Proove Opioid Risk profile showing low addiction risk, correcting the mislabeling and leading clinicians to resolve her treatment complications by narrowing to a single opioid.

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Predictive Accuracy

Evaluation of a Predictive Algorithm that Detects Aberrant Use of Opioids in an Addiction Treatment Centre

Farah J, et al. J Addict Res Ther. 2017;8:2.

The average POR score of patients with diagnosed OUD was significantly greater than controls. The algorithm's ROC curve had an AUC of 0.967 — correctly categorizing patients with OUD nearly 97% of the time, with 98% sensitivity and 100% specificity.

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Clinical Management

An Observational Study of the Impact of Genetic Testing for Pain Perception in the Clinical Management of Chronic Non-Cancer Pain

Sharma M, Kantorovich S, Lee C, et al. J Psychiatr Res. 2017;89:65-72.

Based on genetic testing results, physicians adjusted treatment plans for 40% of patients. When medication changes were made, 72% of patients showed clinical improvement, and physicians believed the genetic test results were consistent with patient pain levels in 85% of cases.

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Primary Care

A Predictive Algorithm to Detect Opioid Use Disorder: What Is the Utility in a Primary Care Setting?

Lee C, Sharma M, Kantorovich S, Brenton A. Health Serv Res Manag Epidemiol. 2018;5.

The profile gave primary care physicians a useful tool to stratify risk of opioid use disorder, rated as beneficial for decision-making and patient improvement by most physicians surveyed — including greater clinical improvement reported for minority patients.

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Validation

Validation Study of a Predictive Algorithm to Evaluate Opioid Use Disorder in a Primary Care Setting

Sharma M, Lee C, Kantorovich S, et al. Health Serv Res Manag Epidemiol. 2017;4.

In a validation study of 452 patients diagnosed with OUD and 1,237 controls, the algorithm categorized high- and moderate-risk patients with 91.8% sensitivity — staying above 90% regardless of changes in OUD prevalence.

Read Full Study

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