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How PCAI is implemented at your clinic

Healthcare professional going through the next steps with a patient

Two ways to use PCAI

Which form suits you depends on how often you meet the difficult cases. For individual borderline cases it is enough to refer the patient to us. If you want to use the analysis on an ongoing basis, we instead set up a workflow with a connected laboratory. The arguments differ somewhat depending on the type of organisation: see what PCAI means for private clinics and for public clinics Public clinics.

For individual cases – recommend a second opinion

In situations where you as a urologist need a more precise basis for making the right decision, you can refer your patient to us for a PCAI-based second opinion. The patient is the one who orders the service, which means that the clinic carries no regulatory responsibility for the analysis.

We handle the process from collecting the biopsy images to delivering the result, in consultation with the patient and with you as the urologist. The result is presented in an easy-to-understand report, followed by a meeting between you and our urologist for further discussion.

  1. Referral

    The urologist refers the patient to spearpoint.se.

  2. A free meeting

    The patient books a meeting with us, gets answers to their questions – and then orders a second opinion if it feels right.

  3. Biopsy images are obtained

    We collect the digitised tissue samples from the laboratory. No new sampling is needed.

  4. PCAI analysis

    The analysis is carried out and reviewed by our urologist. This is how the analysis works in detail How PCAI works.

  5. A written report

    The patient receives a report with a patient section and a medical section addressed to you.

  6. A joint urologist meeting

    An optional three-way meeting between you, our urologist and the patient.

This is what the whole process looks like seen from the patient's side How does it work?.

Regular use of PCAI

If you are interested in using PCAI regularly at your clinic, we offer the opportunity to discuss how this can be integrated into your operations.

The patient's biopsies are sent to a connected laboratory for AI analysis. The result is delivered digitally the same day and gives you a basis for decisions without delay.

Our ambition is that PCAI will eventually be available at every laboratory that works with prostate biopsies. For now, we work separately with each clinic to create a smooth solution for practical use. The fact that the method is robust to differences in section thickness, staining and scanner model is a prerequisite for that – the result should be possible to trust regardless of where the sample was prepared.

Same day

the analysis result is delivered digitally from a connected laboratory

Live copy

6 steps

from referral to a joint urologist meeting

No new samples

the analysis uses the biopsies that have already been taken

What IVDR approval means

IVDR (In Vitro Diagnostic Regulation) is the EU regulatory framework for in vitro diagnostics – the equivalent of FDA approval in the United States. For PCAI to be implemented directly at laboratories as a clinical decision support service, IVDR approval is required. Spearpoint is going through the IVDR process.

Until then, the second opinion model is the way in. It gives the clinic experience of the analysis case by case, without the organisation taking on any regulatory responsibility. Clinics that have already evaluated the service in that model have a considerable head start once IVDR is in place – they can implement directly, without delay.

Discuss PCAI for your clinic

We go through how the analysis can be used at your clinic – as a second opinion for individual cases or in a regular workflow.

Contact us for a walkthrough

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Next steps

Would you like to discuss how PCAI could be used at your particular clinic? The evidence behind the method is in our clinical results. Contact us for a walkthrough tailored to your organisation.

Related: For clinicians · Private clinics · Public clinics

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