Mayo Clinic Laboratories (RT-QuIC Prion CSF, CJD Evaluation profile)

Mayo Clinic Laboratories is the for-profit reference laboratory business wholly owned by Mayo Clinic, working with its Department of Laboratory Medicine and Pathology and serving outside healthcare clients with esoteric testing. For prion disease it is the performing laboratory in Rochester, Minnesota for a second-generation CSF RT-QuIC assay (test code RTQPC), which is orderable only inside two CSF profiles, CJDE (CJD Evaluation) and RPDE (Rapidly Progressive Dementia Evaluation). The tests are laboratory developed under CLIA and not FDA cleared. The US surveillance centre now counts Mayo-tested positives in its probable-case totals: 12 in 2024, 88 in 2025 and 56 in 2026 to mid year. The same business offers Amprion's alpha-synuclein seed amplification test to clients. Mayo Clinic Rochester is also a recruiting site for the PRiSM trial, a separate Mayo unit from the laboratory. Information only, not medical advice.

Key facts

  • Mayo Clinic Laboratories describes itself in a 2025 release as a for-profit, wholly owned subsidiary of Mayo Clinic that serves more than 3,100 clients, offers over 4,200 tests and pathology services and performs more than 31 million tests a year; Mayo notes an indirect financial interest in the technologies it offers.
  • Other Mayo pages cite different scale figures (28 million tests a year and 4,000 plus tests on one page), so size numbers should be treated as approximate.
  • RTQPC is the RT-QuIC prion assay on CSF, run in Rochester on Monday, Tuesday, Thursday and Sunday with reports in 3 to 8 days; it cannot be ordered alone.
  • The assay is developed and validated by Mayo under CLIA and is not cleared or approved by the FDA (CPT 0584U).
  • CJDE combines the RT-QuIC assay with total tau, phospho-tau, their ratio and a written medical interpretation, and is meant for cases where prion disease is strongly suspected on clinical or MRI grounds.
  • RPDE combines RT-QuIC with an Alzheimer disease CSF panel and a tau ratio for rapidly progressive dementia where Alzheimer disease is also plausible; it needs polypropylene tubes and an order received in polystyrene is cancelled and reordered as CJDE.
  • Specimen for CJDE is two unaliquoted CSF tubes after discarding the first 1 to 2 mL, frozen preferred, stable 28 days frozen, 14 days refrigerated and 12 hours ambient, sent with kit T966.
  • The National Prion Disease Pathology Surveillance Center states that its probable-case values include positive RT-QuIC results tested at Mayo, with counts of 12 (2024), 88 (2025) and 56 (2026 to 30 June update).
  • Mayo Clinic Laboratories began offering Amprion's SAAmplify alpha-synuclein CSF test as ASYNC on 26 March 2025, with company-reported 96 percent sensitivity and 92 percent specificity.
  • Mayo Clinic, Rochester is a recruiting site for the PRiSM siRNA trial (NCT07444580, sponsor Broad Institute, collaborator NINDS), with a named principal investigator, Vijay K. Ramanan.
  • A search summary of Mayo materials says the prion test launched in May 2024 after over two years of build time and that only one other US laboratory offered the clinical test beforehand; a press piece repeats the build-time and one-other-lab points.

Timeline

  1. 2018Mayo laboratory staff trained at an outside prion laboratory in Montana before adapting the research assay for clinical use, per a secondary press piece.
  2. 2024Mayo launches the RT-QuIC prion test, per a search summary of Mayo materials (launch page not opened).
  3. 2025Mayo Clinic Laboratories and Amprion announce clinical access to the SAAmplify alpha-synuclein CSF test as ASYNC.
  4. 2026PRiSM trial first posted on ClinicalTrials.gov; Mayo Rochester later listed as a recruiting site.
  5. 2026PRiSM trial start date, actual.
  6. 2026NPDPSC surveillance page updated, counting Mayo-tested RT-QuIC positives for 2024 to 2026.

Last checked 1 November 2026

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