Evidence and limitations

Bioanalytix is built around a simple principle:

Evidence should inform uncertainty, not conceal it.

Genetic research ranges from well-established biological relationships to early associations that may change substantially as new studies are published.

Bioanalytix should make those differences visible.

Three levels of evidence

Established evidence

Established evidence has comparatively strong scientific support for the purpose in which it is being considered.

This may include findings that have been replicated across multiple high-quality studies, supported by strong biological evidence or recognised in authoritative clinical or scientific resources.

"Established" does not mean deterministic.

An established association can still describe probability rather than certainty.

Emerging evidence

Emerging evidence has credible scientific support but remains subject to important uncertainty.

This may include findings that:

• require further replication;
• have modest effect sizes;
• vary between populations;
• depend on environmental or behavioural context; or
• have uncertain practical significance.

Emerging evidence can be useful for exploration without being appropriate for a firm conclusion.

Exploratory evidence

Exploratory evidence includes scientifically interesting findings that remain preliminary, inconsistent or insufficiently validated for stronger interpretation.

Such research may help identify areas worth following.

It should not by itself drive a health or financial decision.

Association is not prediction

A statistical association between a genetic variant and an outcome does not mean that the outcome will occur.

An association may indicate that people with a particular variant had, on average, a different probability of an outcome in the population studied.

The result for an individual can be very different.

Association is not necessarily causation

A variant can be associated with a trait without directly causing it.

Genetic variants can be inherited together, interact with other biological processes or act as markers for genomic regions containing the underlying causal mechanism.

Bioanalytix therefore avoids treating every reported association as a causal explanation.

Effect size matters

Statistical significance and practical significance are different concepts.

A very large study may identify a highly statistically significant association whose effect on individual risk is small.

Bioanalytix should consider the magnitude and relevance of an effect, not merely whether an association has been published.

Population and ancestry matter

Genetic associations and polygenic models may not perform equally across populations.

Differences in ancestry, linkage patterns, environmental exposure and study representation can affect the transferability of research findings.

Historically, genomic research has disproportionately represented people of European ancestry.

Increasing diversity in genomic datasets is improving the evidence base, but important limitations remain.

Genetics is only part of the picture

For most complex traits and common diseases, genetics is one contributor among many.

Relevant non-genetic factors can include:

• age;
• sex;
• family history;
• lifestyle;
• environment;
• socioeconomic circumstances;
• medical history;
• medication;
• healthcare; and
• chance.

A genetic result should therefore be interpreted in context.

Evidence changes

Scientific interpretation evolves.

Larger studies may strengthen an association, reduce its estimated effect, reveal population differences or fail to replicate an earlier finding.

Bioanalytix is designed around the idea that:

the genetic observation can remain the same while the evidence used to interpret it changes.

Health evidence is not a diagnosis

Bioanalytix does not diagnose disease.

Genetic evidence displayed by the platform is intended to support education, evidence exploration and financial scenario analysis.

Questions about diagnosis, treatment, screening or other clinical decisions should be discussed with appropriately qualified healthcare professionals.

Financial scenarios are not investment instructions

Bioanalytix can explore how alternative assumptions about longevity, retirement, spending, investment returns and asset allocation affect financial outcomes.

These scenarios are not instructions to buy, sell or hold a security or financial product.

They are designed to help users understand uncertainty and trade-offs.

The distinction is central to the Bioanalytix approach:

evidence informs scenarios; scenarios inform thinking; people make decisions.