idea-003 · viability deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the investor, and the operator who has to run a regulated consumable business selling into a customer set small enough to name.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-003.md: the number is the claim's position in its ## Claims list, and the tag is copied from that line and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. No number appears here that is not in a claim, and there is no ask slide. See docs/deck-spec.md.
What changed since the 2026-09-15 build: that deck priced an RUO (research use only) reagent with no quality system and a single panel SKU. Under pivot P2 clinical QC material at launch the product is a Class II (FDA device class II) clinical QC (quality control) material under 21 CFR (Title 21 of the Code of Federal Regulations) 866.5910 / product code SCU (subcutaneous), sold as a multi-level panel plus a daily-use single-level control. That changes three things on this deck. The revenue now has a recurring leg, the daily vial. The cost now has a verified fixed layer, a full quality system before first distribution. And the file now carries its own bottom-up demand and price ranges in place of a top-down share of Medicare test revenue, which had rested on a figure since refuted. Rebuilt from the file, not patched.
Would have to be true: A CLIA (Clinical Laboratory Improvement Amendments) laboratory would have to pay for the daily control out of its run-rate operating budget as a recurring consumable, on every patient run-day. Assay developers, whether they report patient results or not, would have to buy the panel out of a development budget.
Where it stands: Nobody bills a payer for this product. It has no code and is bought as an operating input claim 14unconfirmed claim 55unconfirmed. Recurring consumption of control material is mandated: two controls daily per molecular amplification procedure claim 7verified. Recurring purchase from a third party is not, because CLIA names no required material or source claim 76verified. Whether purchasing is recurring at all is open claim 27unconfirmed, as is whether an adopting laboratory uses a vial every run-day rather than only for periodic checks, a condition this deck put on record claim 187unconfirmed. So is whether a scientist can buy it without a capital process claim 26unconfirmed. The non-CLIA buyer group is claimed at ten or more organisations and is not counted by any source claim 154unconfirmed.
What would settle it: Interviews with laboratory budget holders on where control material sits in their budget, and how often an external control is actually loaded.
If it's false: If the budget is project-based, or the vial is used only occasionally, the recurring leg collapses. The business becomes a series of one-time panel sales into a small account set.
Would have to be true: Not for this product, which needs no code, price or coverage of its own claim 55unconfirmed. What has to hold is that the customer's test is coded, priced and covered well enough, across enough volume, to fund a QC line.
Where it stands: Code: the descriptor for CPT (Current Procedural Terminology) 0340U is AMA-licensed and cannot be reproduced here claim 8unconfirmed. Payment: the CY2026 CLFS (clinical laboratory fee schedule) national limitation amount for 0340U is $3,590.00 claim 71verified. Two further MRD (molecular residual disease) codes on the same MolDX article carry $1,800.00 and $1,943.21, and a third is contractor-priced claim 74verified. Coverage: four active MolDX billing articles list 0340U claim 72verified claim 73verified. That establishes existence, not coverage. Whether LCD (local coverage determination) L38779 (a Medicare local coverage determination number) actually provides criteria-gated coverage is unread claim 136unconfirmed. Volume: national Medicare fee-for-service volume for 0340U was 25,746 services in CY2024 claim 68verified, and the file's earlier figure of more than 100,000 is refuted claim 10refuted. That is Medicare FFS (fee-for-service) only. Medicare Advantage (Medicare Advantage), commercial, Medicaid, VA and cash-pay are all outside it, so it is a floor on one channel and not a market size. Vendor-reported all-payer MRD volumes are on record and none is checked claim 114unconfirmed claim 116unconfirmed. The LDT (laboratory-developed test) rule vacatur stands, so these assays remain under CLIA rather than FDA (US Food and Drug Administration) premarket review claim 66verified.
What would settle it: A human reading L38779's text. All-payer volume from Natera's and Guardant's SEC filings, attached by a human, since this repo has no EDGAR connector.
If it's false: This does not stop the product directly. A poorly covered customer test lowers what a laboratory can spend on QC, and it would squeeze the price on slide 3.
Would have to be true: Annual revenue would have to come from two legs, each with its own inputs. The panel: organisations x panels per year x capture share x price. The daily vial: laboratories x run-days x one vial per run-day x capture share x price. Together they would have to clear the fully loaded cost on slide 4, without using the refuted volume figure anywhere.
Where it stands: Every input is on record and none is checked. The addressable laboratories are 30-60 claim 12unconfirmed. Panel demand available to one new supplier by year 3 is 2-400 a year claim 150unconfirmed. Vial demand is 500-5,000 a year claim 151unconfirmed. Capture share rests on claim 47unconfirmed claim 47unconfirmed. The prices are $1,500-$3,000 per panel and $400-$900 per vial claim 149unconfirmed. At the file's own planning points (50 panels, 2,000 vials, low-end prices) revenue is about $875,000 a year, of which the vial leg is the larger part claim 178unconfirmed. On claim 151unconfirmed's own derivation, vial demand scales with laboratories and run-days, not with patient test volume, so growth in MRD test volume raises the customers' revenue without moving the vial count directly. The file's older top-down sizing, a QC-spend share of downstream test revenue, rested on the refuted volume claim 10refuted and on an unsourced share claim 11unconfirmed. Which of the two methods is right is itself an open question claim 57unconfirmed. The file's Stage 5 check records that TAM (total addressable market) sits exactly at the floor, and that one adverse verified finding on price or capture would put it below.
What would settle it: A human-built enumeration of US laboratories running tumor-informed MRD assays (the MolDX-registered lab list, CAP and NY CLEP directories). Then the slide 7 price test.
If it's false: TAM drops below its floor, and the one Stage 5 kill condition the file calls its closest call fires.
Would have to be true: P2 clinical QC material at launch's fixed layer would have to fit inside the low-single-digit- million first-revenue budget the file states. That layer is a 21 CFR 820 / ISO (International Organization for Standardization) 13485 quality system with design controls, UDI (unique device identifier) and complaint handling, the special-controls study set, and three production lots on independent plasma pools. The calendar to first distribution would also have to be known, since the file's only stated calendar predates the layer.
Where it stands: The obligation is verified. SCU, NZB and QIG are not GMP-exempt, and 21 CFR 820.10 requires the quality system, design controls, UDI and complaint reporting before distribution claim 159verified. The budget it has to fit in is the P0 the original shape estimate claim 20unconfirmed, and every verified line about that estimate weakens it: it names no production volume claim 58verified, no supplier claim 59verified, and it does not itemise the donor-screening cost 21 CFR 610.40 imposes claim 61verified. Whether the P2 clinical QC material at launch layer fits is a condition put on record by the business case claim 180unconfirmed. So is the proposition that first distribution now takes longer than the 9-15 months the file states for the RUO shape claim 179unconfirmed claim 50unconfirmed. The study set is claimed from the special-controls guidance, which is not attached claim 158unconfirmed. The three lots are claim 170unconfirmed claim 170unconfirmed. A contract manufacturer already listed under 866.5910 could shorten this claim 171unconfirmed, but only if it would toll the vial below the low end of its price claim 181unconfirmed. Whether the panel can be made below the incumbent's $1,919.59 distributor price is unmodelled claim 140unconfirmed.
What would settle it: A bottom-up build plan and calendar: quality-system cost, the special-controls study plan, plasma and cell-line quotes, and a toll-manufacturing quote from an establishment listed under SCU, NZB or QIG. All of these are documents a human attaches.
If it's false: The capital factor, already at 2 on verified evidence, has nothing left holding it up, and time to first revenue becomes unknown rather than short.
Would have to be true: A fast-following vendor would have to be unable to win MRD laboratories without matching this product's characterization dataset and uncertainty documentation. No rule on the customer side could make that documentation optional.
Where it stands: The moat is stated claim 19unconfirmed claim 128unconfirmed, and the verified evidence around it leans the wrong way. CLIA requires no material, source or traceability for sensitivity claim 76verified, and traceability appears only for calibrators, "if possible" claim 77verified. The one supportive published finding, that well-defined variants are preferable for sensitivity and precision, is something incumbents can offer too claim 90verified. P2 clinical QC material at launch's quality-system layer claim 159verified is an entry cost that favours a vendor already holding ISO 13485, and one incumbent claims exactly that claim 86unconfirmed. Whether laboratories would pay more for an ISO 17034 producer is open claim 129unconfirmed. Whether P1 derived-value bottom levels's value-assignment combination is novel enough to protect has not been searched claim 175unconfirmed.
What would settle it: The CAP and MolDX readings on desirability slide 3, and a patentability search on the P1 derived-value bottom levels combination.
If it's false: The moat factor has no upside past 2. The product's defence is being first and nothing more, which puts the weight on slide 6.
Would have to be true: No incumbent would already sell, or would ship before this product's first distribution, a human-plasma-matrix ctDNA (circulating tumour DNA) control with characterized levels below 0.1% VAF (variant allele frequency).
Where it stands: That none sells one today is recorded and unchecked claim 184unconfirmed. That none will ship one first is a condition this deck put on record claim 188unconfirmed. The nearest incumbent product reaches down to a nominal 0.005% but in Tris/EDTA buffer rather than plasma claim 111unconfirmed, with dPCR (digital polymerase chain reaction) for only one blend and no stated uncertainty claim 101unconfirmed, at $1,919.59 through a distributor claim 117unconfirmed. Plasma-like or synthetic-plasma products stop at 0.1% claim 119unconfirmed claim 46unconfirmed, as does Twist's set claim 121unconfirmed. A plasma-matrix ctDNA control is sold at $490 direct and $1,617 through a distributor claim 123unconfirmed claim 124unconfirmed. Commercial contrived material at and above 0.1% is verified to exist claim 94verified. FDA's oncology control code already has listings claimed under it claim 132unconfirmed, and a third-party oncology-monitoring control is claimed to be distributed exempt under 866.5910 claim 155unconfirmed. An incumbent might license rather than build claim 51unconfirmed, and whether any has done so before is recorded and unchecked claim 182unconfirmed.
What would settle it: Vendor datasheets and certificates of analysis for every ctDNA control sold in the US, attached by a human, and a read of FDA's registration and listing records for SCU, NZB and QIG.
If it's false: The white space below 0.1% in plasma closes, competitive intensity stays at 2 or falls, and the price premium on slide 7 has nothing to rest on.
Would have to be true: A direct quote for the incumbent's MRD Panel Mix, together with a handful of laboratory pricing conversations, would have to leave room for this product's claimed price and premium.
Where it stands: Whether a laboratory buying direct pays near the distributor price or materially below it is open claim 152unconfirmed. The vendor's own store shows no price without sign-in claim 120unconfirmed. The premium for plasma matrix with stated uncertainty is claimed at 25% or more claim 153unconfirmed. No quote has been requested [no claim].
What would settle it: A human asking SeraCare/LGC for a quote, which costs nothing, and the same interviews desirability slide 6 calls for, with the price asked explicitly.
If it's false: The price range in claim 149unconfirmed falls, and the revenue arithmetic on slide 3 falls with it.
Every condition above with nothing verified behind the condition itself. Slides 1, 2, 4 and 5 carry verified lines, but those lines establish context or add cost. None of them establishes what the slide needs. Slide 2's customer-side price, volume floor and article existence are the nearest to backing, and its load-bearing half (coverage under L38779) is unread. Seven of seven conditions.
If only one thing from this chair could be checked: whether, at the file's own planning volumes (50 panels and 2,000 daily vials a year) and the low end of its own prices, annual revenue of about $875,000 exceeds the fully loaded cost of goods plus the recurring cost of the 866.5910 obligations claim 178unconfirmed. The cost side of that comparison has no figure anywhere in the file.
This one rather than the others because it is where P2 clinical QC material at launch's two changes meet. The daily vial adds the revenue, and the quality system adds the recurring cost. Every other slide on this deck is an input to one side of that comparison. Naming it is not a recommendation, a gate, or a kill. It is the answer to "check what first."
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