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PROMPT REGISTRY · RESEARCH DESK

Genetic diagnostics, from swab to sequencer

An evidence desk on hereditary-cancer testing, in the heritage of the Prospective Registry of Multiplex Testing — a real multi-institution registry whose findings on multi-gene panels are cited across ASCO and the Journal of Clinical Oncology. Explainers only; for personal decisions, see a clinician or genetic counsellor.

~13%
of women in the general population develop breast cancer in their lifetime
NCI
>60%
lifetime breast-cancer risk in carriers of a harmful BRCA1/BRCA2 variant
NCI
~10–15%
diagnostic yield of multi-gene panels in high-risk cohorts
JCO Precision Oncology
~500×
typical read depth for clinical multi-gene panel testing
Eur J Hum Genet

From swab to sequencer

A simplified view of the path a hereditary-cancer specimen takes through the diagnostic chain.

  1. 01

    Collect

    A saliva kit such as OG-500 captures ~2 mL of sample, mixed on the spot with a stabilising buffer so cells lyse cleanly and nucleases are held in check.

  2. 02

    Stabilise & ship

    Stabilised saliva is room-temperature stable for months, letting samples travel by post in UN3373 biological-substance packaging rather than on ice.

  3. 03

    Extract

    In the lab, DNA is purified from the lysate; saliva typically yields more total DNA than a buccal swab, easing downstream library prep.

  4. 04

    Sequence

    A targeted panel is sequenced — commonly to ~500× mean depth — so heterozygous germline variants are called with confidence across genes like BRCA1, BRCA2, PALB2, CHEK2, and ATM.

  5. 05

    Classify & report

    Each variant is graded against ACMG/AMP criteria into one of five tiers, from benign to pathogenic — with uncertain calls flagged rather than forced.

Collection methods compared

Yield and stability differ by method; figures below reflect manufacturer technical specifications and peer-reviewed comparisons, and vary by donor and handling.

MethodSampleTypical DNA yieldStabilityNotes
Stabilised saliva (OG-500)~2 mL~110 µg (range ~15–300+ µg)Room temp, up to ~30 monthsNon-invasive; highest typical total yield
Buccal swabCheek scrapeLower than salivaDays–weeks (kit-dependent)Convenient but lower yield
Blood draw (EDTA)~2–10 mLHigh, high-purityRefrigerated; days unfrozenGold-standard purity; venipuncture required

Table 1. Indicative DNA yield and stability by collection method.

Fig. 1

Lifetime breast-cancer risk: carriers vs general population

General population13 %
BRCA1/BRCA2 carrier62 %

Approximate lifetime female breast-cancer risk. General-population and BRCA carrier figures per NCI; carrier risk commonly cited as exceeding 60%.

How a result is graded

The 2015 ACMG/AMP framework sorts germline sequence variants into five tiers — the language behind every line of a panel report.

Pathogenic (P)
Strong, combined evidence that the variant causes disease.
Likely pathogenic (LP)
High probability (commonly ~90%+) of being disease-causing, short of certainty.
VUS
Variant of uncertain significance — insufficient evidence to call either way; not a basis for action on its own. The PROMPT registry was built in part to track these over time.
Likely benign (LB)
Evidence leans against a clinical effect.
Benign (B)
Considered not to cause the condition.
swab → sequencer
PROVENANCE

About the PROMPT Registry

The Prospective Registry of Multiplex Testing (PROMPT) is a real, multi-institution registry launched in 2014 for people who underwent multi-gene panel testing for cancer susceptibility. Participants carrying pathogenic variants or a VUS self-enrolled, and the registry followed them over time — work cited across ASCO meetings and the Journal of Clinical Oncology.

This desk honours that lineage as an educational explainer. We do not run the original study, we are not enrolling participants, and nothing here is medical advice. For your own testing or results, speak with a clinician or genetic counsellor.

A variant of uncertain significance is not a diagnosis — it is a question the evidence has not yet answered. Registries exist to keep asking it.
PROMPT Registry · research desk

Start at the diagnostics hub

Trace a specimen from swab to sequencer, hub by hub — collection, testing, lab, logistics. Evidence-led, citation-minded, and free of sales.