Lucid Diligence Brief: Circular Genomics $15 million Series A for circular RNA biomarkers

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Seven questions, 60-second thesis frame.

What changed, and when

Circular Genomics closed a 15 million dollar Series A on 01 Dec 2025 to advance its circular RNA blood-biomarker platform for early detection of Alzheimer’s disease, led by Mountain Group Partners with Poplar Grove Investors, HIP Fund, and the Alzheimer’s Drug Discovery Foundation participating (PR Newswire release). Independent trade coverage confirms the round and investor line-up (BioSpace brief, Clinical Lab Products note).

60-second thesis frame

Signal is rising that circRNAs could become a distinct, brain-derived blood biomarker class for AD, potentially complementing or competing with today’s p-tau217-centric assays. Circular Genomics has a CLIA LDT track record in psychiatry with its MindLight assay, and now points that platform at AD with a CTAD 2025 data readout this week, which is the near-term proof point (MindLight product page, company CTAD announcement, 24 Nov 2025). The market context is hotter and more regulated, since the FDA cleared the first AD blood test in May 2025, which anchors clinical expectations and payer scrutiny (FDA clearance, p-tau217/amyloid plasma ratio, 16 May 2025, Reuters recap). Reimbursement is still evolving, with PLA codes emerging for leading p-tau217 tests, but coverage remains patchy, especially for LDTs, and the LDT regulatory back-and-forth adds uncertainty into 2026 (AMA PLA code list excerpt, AAPL/AAPC page for 0479U, ALZpath pTau217, FDA LDT page updated after court vacatur, Sept 2025).

The seven diligence questions

Clinical

• What is the circRNA panel’s head-to-head accuracy versus plasma p-tau217 assays and CSF/PET across settings, especially primary care, and how robust are AUC and calibration on external cohorts (ask for CTAD 2025 deck and statistical analysis plan) (company CTAD notice, Nature Medicine p-tau217 performance context).
• Does the circRNA signature predict progression in pre-symptomatic or MCI populations better than existing markers, and is it additive to p-tau217 or ApoE-stratified risk models (company CTAD notice).

Payer or Access

• What coding and pricing pathway is planned, PLA versus existing CPTs, and how will they navigate payer policies that still list AD biomarkers as investigational in many plans (AAPL/AAPC 0479U reference, Blue/Anthem policy exemplar updated Jul 2025).
• Will the product be an LDT under CLIA in 2026 or pursue FDA clearance, given the 2025 LDT rule vacatur and FDA reversion, which heightens perceived device-like oversight risk later on (FDA LDT page, Sept 2025 update).

Ops or Adoption

• What is the CLIA/CAP status and lab throughput, and can they meet turnaround times comparable to p-tau217 labs used by Quest and Neurocode in a national roll-out (Quest AD-Detect listings, Neurocode ALZpath pTau217 test).

Competitive

• How will circRNA positioning compete or complement the now-FDA-cleared plasma p-tau217 ratio test, and do providers need both in workflow for eligibility, confirmation, and longitudinal monitoring (FDA clearance, May 2025, Quest AD-Detect news, Oct 2025).

Team or Cap table

• Does the current investor group have deep diagnostics go-to-market capacity, and is follow-on capital lined up for regulatory studies and commercialization beyond the reported 15 million dollars (PR Newswire release, BioSpace brief).

Red flags

• Clinical non-inferiority to p-tau217 may be necessary in community settings. If CTAD data do not show external validation and clear incremental value, adoption risk rises (Nature Medicine p-tau217 study).
• Regulatory path ambiguity for LDTs could re-emerge, creating timing and evidence shifts if FDA tightens enforcement in 2026 (FDA LDT page, Sept 2025).
• Reimbursement friction persists. Even with PLA codes, several plans still deem AD blood biomarkers investigational, slowing coverage and contracting (Anthem policy LAB.00046, Jul 2025).

Next catalyst

CTAD 2025 oral presentation, “Identifying and stratifying Alzheimer’s disease using circular RNA biomarkers in blood,” scheduled 03 Dec 2025 in San Diego; watch for slides and full metrics after the session (company CTAD announcement, 24 Nov 2025).

FAQ

• What exactly changed by Circular Genomics’ “15 million dollar Series A financing” news on 01 Dec 2025, and why does it matter for Alzheimer’s diagnostics?
  The company raised 15 million dollars, led by Mountain Group Partners, to accelerate clinical validation and commercialization of its circRNA blood-biomarker platform for early AD detection. This adds a new biologically distinct marker class to a market led by p-tau217 assays (PR Newswire release, Clinical Lab Products note).
• What is the regulatory path after Circular Genomics’ 01 Dec 2025 financing news, and what are the next formal steps in the US, UK, and EU?
  In the US, the first FDA-cleared AD blood test arrived in May 2025, setting a benchmark for prospective studies if seeking clearance. LDT policy is fluid after the 2025 court vacatur, so a near-term CLIA LDT launch in the US with future FDA filing is plausible, while UK and EU routes would require UKCA/CE-IVD strategies (FDA clearance, May 2025, FDA LDT page update, Sept 2025).
• Which endpoints in the Circular Genomics’ CTAD-linked AD program matter most, and what effect sizes should investors watch?
  Look for AUC, sensitivity, specificity versus CSF/PET and p-tau217 comparators, plus calibration and decision-curve analyses in external cohorts. Progression prediction in cognitively normal or MCI subgroups would be especially meaningful for early identification claims (company CTAD announcement, Nature Medicine p-tau217 performance context).
• What safety or real-world issues shape adoption after the Circular Genomics’ 01 Dec 2025 financing news, and do they change use?
  Safety is not the constraint for blood biomarkers, but false positives and care-pathway drift are. FDA-cleared p-tau217 ratio assays now define expectations for accuracy and utility that new biomarkers must match or exceed in practice (FDA clearance, Quest AD-Detect overview).
• How will major US payers treat access after Circular Genomics’ 01 Dec 2025 financing news, and are codes available today?
  Several p-tau217 assays have PLA pathways, but many commercial payers still list AD biomarker tests as investigational, making coverage inconsistent and often patient-pay. Coding via PLA codes like 0479U for ALZpath pTau217 shows the template, yet coverage decisions remain plan-specific (AAPL/AAPC 0479U page, Anthem policy LAB.00046).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 02 Dec 2025, 14:24 London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. © 2025 LucidQuest Ventures Ltd.

Entities / Keywords

Circular Genomics; MindLight; Alzheimer’s disease; circRNA; circular RNA biomarkers; Clinical Trials on Alzheimer’s Disease, CTAD 2025; Mountain Group Partners; Poplar Grove Investors; HIP Fund; Alzheimer’s Drug Discovery Foundation; FDA; LDT; CLIA; CAP; p-tau217; ALZpath; Neurocode; Quest Diagnostics AD-Detect; Fujirebio; Lumipulse plasma pTau217/amyloid ratio; CPT PLA 0479U; payer policy; Anthem; reimbursement; PET; CSF; amyloid; tau; progression prediction; early detection; precision neurology; San Diego; London.

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