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Fibromyalgia
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====Blood tests and biomarkers==== EpicGenetics developed the '''FM/a test''' blood test to diagnose FM in 2017 - and announced a linked treatment trial involving the BCG vaccine soon after; the trial has since been suspended indefinitely.<ref name="controversy2021" /><ref name="fmtest">{{Cite web | url = http://fmtest.com/ | title = Home | last = |website=EpicGenetics' FM/a® Test is FDA-compliant and has successfully diagnosed patients with fibromyalgia since 2012.|language=en-US|access-date=2019-03-25}}</ref><ref name="FMa test" /> Dr Denise Faustman at Massachusetts General Hospital, who was due to conduct the trial, stated that the test should never have been marketed as a requirement for the treatment trial, and that no patients were ever recruited to the trial.<ref name="FMa test" /> The FM/a test continues to be marketed despite the suspension of the linked treatment trial,<ref name="FMa test" /> and the fact that only two studies have been published using the test - the last being published in 2015.<ref name="PMC3534336" /><ref name="PMC4435905" /> The evidence base supporting the use of the test has been reported to be weak, and no studies have assessed whether the test can correctly determine which patients have fibromyalgia and have some fibromyalgia symptoms that are explained by another diagnosis.<ref name="controversy2021" /> One study did not include any men.<ref name="PMC3534336" /> IsolateFibromyalgia, IQuity's RNA based blood test for fibromyalgia, was first announced in 2018 but no peer-reviewed studies have been published. A '''non-invasive eye test''' has found eye abnormalities in people with fibromyalgia, with Garcia et al 2016 finding reduced retinal nerve fiber layer (RNFL) thickness, raising hopes of a non-invasive eye test may help diagnose FM.<ref name="Garcia2016">{{Cite journal | last = Garcia-Martin | first = Elena | last2 = Garcia-Campayo | first2 = Javier | last3 = Puebla-Guedea | first3 = Marta | last4 = Ascaso | first4 = Francisco J. | last5 = Roca | first5 = Miguel | last6 = Gutierrez-Ruiz | first6 = Fernando | last7 = Vilades | first7 = Elisa | last8 = Polo | first8 = Vicente | last9 = Larrosa | first9 = Jose M. | date = 2016-09-01 | title = Fibromyalgia Is Correlated with Retinal Nerve Fiber Layer Thinning | url =https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008644/|journal=PLoS ONE|volume=11|issue=9| pages = e0161574|doi=10.1371/journal.pone.0161574|issn=1932-6203|pmc=5008644|pmid=27584145}}</ref> The findings were confirmed by Cordón et al 2021, who found that disease severity and reduced quality of life were associated with reduced RNFL.<ref name="Cordon2021">{{Cite journal | last = Cordón | first = B. | last2 = Orduna | first2 = E. | last3 = Viladés | first3 = E. | last4 = Garcia-Martin | first4 = E. | last5 = Garcia-Campayo | first5 = J. | last6 = Puebla-Guedea | first6 = M. | last7 = Polo | first7 = V. | last8 = Larrosa | first8 = J.M. | last9 = Pablo | first9 = L.E. | date = 2021-07-02 | title = Analysis of Retinal Layers in Fibromyalgia Patients with Premium Protocol in Optical Tomography Coherence and Quality of Life | url =https://doi.org/10.1080/02713683.2021.1951301|journal=Current Eye Research|volume=0|issue=0 | pages = 1–11|doi=10.1080/02713683.2021.1951301|issn=0271-3683|pmid=34213409}}</ref> The test requires optical coherence tomography (OCT), which is fast and non-invasive.<ref name="Cordon2021" /> At present, there is no eye test in clinical use for diagnosing FM. In 2019, Hackshaw and colleagues found a unique metabolic fingerprint using a blood spot test that distinguished between fibromyalgia, rheumatoid arthritis and lupus, which they suggested could act as a diagnostic biomarker for FM.<ref name="Hackshaw2019">{{Cite journal | last = Hackshaw | first = Kevin V. | last2 = Aykas | first2 = Didem P. | last3 = Sigurdson | first3 = Gregory T. | last4 = Plans | first4 = Marcal | last5 = Madiai | first5 = Francesca | last6 = Yu | first6 = Lianbo | last7 = Buffington | first7 = Charles A.T. | last8 = Giusti | first8 = M. Mónica | last9 = Rodriguez-Saona | first9 = Luis | date = 2019-02-15 | title = Metabolic fingerprinting for diagnosis of fibromyalgia and other rheumatologic disorders |url =https://www.jbc.org/article/S0021-9258(20)40006-7/abstract|journal=Journal of Biological Chemistry|language=English|volume=294|issue=7 | pages = 2555–2568|doi=10.1074/jbc.RA118.005816|issn=0021-9258}}</ref> [[Heart rate variability]] (HRV) measured by ECG is a possible fibromyalgia biomarker, since it is reduced in people with FM, but heart rate is affected by many different factors so this may be problematic.<ref name="Hackshaw2021" />
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