We say the limitation first.
Diagnostics is a category where the marketing usually runs ahead of the evidence. This page is the opposite exercise: the laboratory standard, the regulatory status, the words we refuse to use, and a list of claims we removed from our own material rather than defend them.
Three things we put in writing before you order.
Each of these can end a conversation on its own, which is exactly why they go first rather than into a footnote after the contract.
CLIA certificate and accreditation
The certificate number and accreditation status of the performing laboratory. A vendor who cannot name their laboratory is asking you to take the risk on trust.
Assay methods, named
Where a marker needs mass spectrometry to be reliable at the concentrations being treated — testosterone, and estradiol at male concentrations — we say so, or we drop the claim.
Turnaround, measured
Not a category average. The actual round trip to a named address, committed in the agreement, with home-collection shipping counted rather than excluded.
All laboratory analysis happens off-site at our CLIA-certified partner laboratory. No part of it is run inside a partner practice, which is deliberate: running any part of the analysis in an office would require that office to hold its own CLIA certificate.
What these panels are, in the regulator’s terms.
Stated the same way on every page of this site, in every deck, and on every report.
What they are
- Laboratory-developed tests. Performed by a CLIA-certified laboratory and ordered by a licensed clinician.
- Quantitative measurements against laboratory-defined ranges. Documented, repeatable and re-testable after an intervention.
- Cash-pay, outside the insured encounter. Nothing here is billed to Medicare, Medicaid or any federal healthcare programme. It sits beside insured care, never inside it.
What they are not
- Not FDA-cleared or approved. No panel on this site is cleared or approved by the FDA for the indications described.
- Not diagnostic. They do not diagnose, stage or grade disease. Results inform clinical judgement; they do not replace it.
- Not screening tests for systemic disease. Screening requires established sensitivity, specificity and outcome benefit. Where that evidence does not exist, we do not use the word.
Six words we will not use, and what we say instead.
Most claims problems in this category are vocabulary problems.
| Word | Why it is a problem | What we say instead |
|---|---|---|
| Screening | A term of art requiring established sensitivity, specificity and outcome benefit. | Quantitative measurement, or detection within a validated indication. |
| Diagnose | Diagnosis is a clinical act performed by a clinician with the patient in front of them. | Informs a diagnosis. Prompts clinical correlation. |
| Predicts | No panel here establishes procedure candidacy, predicts treatment success or improves outcomes. | Associated with. Measured before and after. |
| Detects [systemic disease] | Association is not detection, and a marker on a panel is not an assay for a distant organ. | Quantifies [the analyte]. Associated with [the condition] in the literature. |
| Rules out | Exclusion requires a validated pretest-probability framework and a turnaround the workflow can support. | Nothing. We do not make exclusion claims on any panel. |
| Optimises / restores | Outcome language for products with no outcome evidence in the population being sold to. | Changes [the measured marker]. We name the marker and stop. |
Provider-only, and described as such.
These lines are not consumer products and we do not market them as though they were.
Physician-ordered, provider-supplied
Peptide and regenerative products are supplied to licensed healthcare providers only, on a physician’s order through licensed pharmacy channels. Pricing, COAs and titration schedules sit behind licensure verification.
No indication claim
We supply the product, the certificate of analysis and the protocol reference. Clinical decisions, consent and indication are the treating physician’s. Regulatory status varies by category and changes — we confirm the current status per SKU at contracting.
No efficacy claim we cannot source
Growth hormone secretagogues change body composition. That is not the same as a functional benefit and we do not claim one. Where a controlled trial of a comparable product was negative, we say so rather than omit it.
Cautions carried in writing
Where a compound has a population-specific risk — PT-141 in uncontrolled hypertension, IGF-1 in men on androgens, the GH-plus-testosterone adverse event profile — the caution ships with the product reference.
How to challenge anything on this site.
If a claim anywhere on aapmedical.com does not survive a look at the primary literature, we want to know before your patients do.
Send us the page and the claim
Email partners@aapmedical.com with the URL and the sentence. A citation helps but is not required.
We check it against the source
Not against our own material. If the primary literature does not support it, it comes down or it gets rewritten.
We tell you what changed
And if you were right, the claim joins the list above rather than quietly disappearing.
What is still open on our side
Two things a careful buyer should ask us for directly rather than assume from this page, because they are practice-specific and we will not generalise them:
- The performing laboratory’s current CLIA certificate number and accreditation status — we send it on request, before you order.
- The clinic-side price and analyte list for any reconfigured panel, including the TRT Baseline configuration, confirmed against current cost rather than quoted from a deck.
Ask us the hard question first.
We would rather lose a meeting on a straight answer than win one on a claim that does not survive your medical director.
Nothing on this page is legal advice. Coding, scope and billing rules vary by state — confirm with your own advisors before you launch.