Data anchored, awaiting direct validation: how we describe what Spherix knows | Burgeon Studio Insights
Research Notes10 September 2026

Data anchored, awaiting direct validation: how we describe what Spherix knows.

The Spherix dermal fibroblast model is built on published measurements and is consistent with published observations. No published dataset yet measures the inside of these spheroids directly. We think that sentence belongs on the front of the product, so here is how we write it and why.

By Burgeon Studio Research TeamEstimated read: 6 minutes

What the status says

Our dermal fibroblast model is described on the product as data anchored and awaiting direct validation. Each part of that phrase is deliberate.

Data anchored means its inputs come from published measurements, including measured oxygen consumption and cell density for dermal fibroblasts, rather than values borrowed from studies of other cell types such as tumour cells.

Its predictions are consistent with published observations of dermal fibroblast spheroids, and the simulation engine, PhysiCell, is itself open source and peer reviewed3. That is a modest claim, and it is the one we can support.

Awaiting direct validation means that no published dataset yet measures the inside of these spheroids directly. Until one does, we cannot say the model has been validated, and we do not say it.

A model that states its limits is easier to trust than one that hides them.

What we do not say

We do not describe the model as validated. We do not suggest it replaces laboratory experiments. We do not suggest it is the only tool of its kind. Spherix is for research use only, and it is not for clinical, diagnostic or regulatory decisions.

Why the wording matters

Model credibility is a recognised discipline. The ASME V&V 40 standard1 and the FDA’s guidance on the credibility of computational modelling in medical device submissions2 both ask that the evidence behind a model be matched to the decision it informs. Spherix is for research use only, and we make no claim of compliance with either document. We borrow the habit: state the evidence next to the result.

Labels on every input

Cell types other than the flagship are available in Spherix, and each is labelled by how strong its evidence is: Measured, Derived or Predicted. These labels are our own scheme, not an external standard.

Choose a label to see what it means. The bars show relative strength of evidence.

Every number in a Spherix report shows where it came from and how far it has been validated. A Validation tab lists what the model has and has not been tested against, and every result carries a 90% uncertainty range.

How a lab can close the gap

Every prediction corresponds to an assay that labs already run: live/dead imaging, histology, hypoxia staining and oxygen probes. A lab that grows a dermal fibroblast spheroid under the same conditions can compare its own measurements with the prediction.

That comparison is the direct validation the field is waiting for. We would like to see it done openly, whatever it shows.

Sources
  1. ASME V&V 40 (2018), “Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices.”
  2. US Food and Drug Administration, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.”
  3. Ghaffarizadeh et al., “PhysiCell: An open source physics based cell simulator for 3D multicellular systems,” PLOS Computational Biology 14(2): e1005991 (2018).

Spherix is a decision support tool for ranking and narrowing designs before wet lab work. It is not a replacement for experiments.

Spherix is for research use only. It is not for clinical, diagnostic or regulatory decisions.

The validation status described here is Burgeon Studio’s own statement about its own model.