Crowdfunding Proposal

Welcome to our Crowdfunding Proposal for the Process Record Slide (PRS) to be FDA registered. The PRS is a must-have product for all pathology laboratories as specified by the World Health Organization (WHO) quality guidelines.

We are looking to raise the following amount:

GOAL: USD250k – 5000 trials @ USD 5 for each trial (10 pcs)


Patents: 6 Patents filed


Clinical Information: Medical device


Regulatory Status: FDA class 1 filed as slide to slide calibrator

How we will use the funds raised:

1

Manufacturing of the process record slide

2

Further research on primary IHC process

Investment opportunity

The purpose of this crowdfunding is to raise funds for support from the pre-selling of the product. We also seek agreement from the circle of pathologists and professional in the field that our product is indeed the vital missing link in their IHC process.

We don’t provide equity for the money received but will exchange the product to trial.

About the Process Record Slide (PRS)

PRS was released by Process Record Slide Limited based in Hong Kong.

We provide a must-have solution for laboratories, hospitals and pathologists with our new PRS product.

There is an urgent need to fill the gap when it comes to the elusive missing-link within the global laboratory quality system.

With our company’s creation of the innovative Process Record Slide (PRS) we are able to meet that need in a very precise and exacting way.

How the PRS helps physicians

The Process Record Slide (PRS) is a must-have FDA registered medical device that aids pre-screening by lab technicians and pathologist diagnostic interpretation efforts.

The PRS will:

Provide a record of the processing experience that the target and the tissue sections experienced. The target data can be used to verify that the processing and/or reagents are functioning within their tolerance limits as defined in the laboratory’s process control documents.
Record the IHC staining experience and identify process or reagent deficiencies that may occur.
Change the subjective diagnostic interpretation into objective interpretation because the efficacy of the IHC processing is known to be valid via the PRS target results.
Validate and support corroborative second opinion and tele-diagnostics within even remote communities across the globe.

 How the PRS helps pathologists

For a long time, colleges of pathology and government FDAs have been calling for independent real-time control for each staining process but this has never been possible until today with the new PRS product. Government FDA and colleges of pathology across the world have sought QC and process tracking information for the medical stain processing activities.  Some have gone so far as to have the requirements already documented for the time when such technology should become viable and cost effective.  The waiting is over as the PRS addresses the needs on all fronts.

We strongly recommend that all laboratories consider using PRS for their biopsy staining process particularly in view of the fact that WHO states this quality control component is an essential element.  By including this, the laboratory will be provided with authority, conviction and confidence in being able to prove that the test results are accurate and reliable prior to the patient results being created.

The PRS has created a new break-through in pathology because it:

Provides a break-through calibration concept of antigen concentration baseline scale for digital imaging.
Each slide incorporates its own record of the staining experience that can be used to evaluate the co-resident tissue section for QC feedback and cloud based analysis.
A pathologist can only generate a good diagnosis when the slide has been correctly processed, the biopsy material was fixed correctly, and the section contains the abnormal cellular condition. When the pathologist has confidence in the efficacy of the slide to be interpreted, then his analysis will yield high diagnostic value.

Most important of all, PRS works alongside all staining systems.

How the PRS helps laboratories

We strongly recommend that all laboratories consider using PRS for their IHC biopsy staining process particularly in view of the fact that WHO states this quality control component is an essential element. By including this, the laboratory can confirm the efficacy of reagents used, tissue handling, and process control of the patient sample through the IHC processing. Thus, the laboratory can document that its processing of the biopsy sample is valid prior to the diagnostic interpretation being performed.  Of course, the biopsy may not contain any of the sought for conditions and the outcome would be a true negative result.

To Support Us

Disclaimer: Although we expect our product will be launched in September or October in 2017, the purchaser may expect delay or even non-delivery of the product.