EXO GFC Clinical Evidence Review Sheet

EXO GFC from NovaClin Labs is coming soon. Clinics evaluating a future product file can use this worksheet to separate the named system, laboratory information and clinical evidence.

Start with the exact claim

Write the product claim in one sentence and identify the source document, date and product reference. Then record what evidence the document actually provides for that claim.

Review field	What to enter
System identified	Manufacturer, product name and kit or model reference
Study design	Laboratory study, clinical study or another specified evidence type
Population or sample	What was studied and the number evaluated
Comparison	The control or comparator, if any
Outcome	The measurement actually reported
Follow-up	When the outcome was assessed
Applicability	How the studied system relates to the product under review

Keep different evidence types separate

A processing description, a laboratory measurement and a clinical endpoint answer different questions. Record each under its own heading so an observation about a sample is not automatically presented as a patient outcome.

The ISEV MISEV2023 reference addresses rigour and reporting in extracellular-vesicle research. It is not a clinical evaluation or approval of EXO GFC.

Finish with questions your team can resolve

List the documents required to connect the kit identity, supplied instructions and a particular claim. Keep any uncertainty specific: for example, whether a report identifies the same system, uses a suitable comparison or measures the outcome being discussed.

Ask for the current product contents and instructions when available, without deriving them from the EXO GFC name.

Send an EXO GFC product enquiry

Include your clinic, professional role and the exact documents or launch information requested. View the EXO GFC product page or contact NovaClin Labs.