Precipio Inc. (NASDAQ: PRPO) has announced that most large laboratories have finalized validation studies testing the company’s IV-Cell cytogenetics media product and the HemeScreen Assay. The company has also indicated that Tennessee Oncology has chosen the HemeScreen Assay as their molecular testing assay for myeloproliferative neoplasms (MPD) and myelodysplastic syndromes (MDS).
Completion of validation studies and commercialization
The labs should undergo a comprehensive process to introduce IV-Cell cytogenetics media as well as HemeScreen Assay into clinical work-flow. This encompasses complex testing and comparison to the Lab’s current process to ensure there is a consistent and enhanced performance of the products.
The product is ready for placing orders but each customer has different acceptance procedures that it should meet. Once the labs have demonstrated this and other parameters they can proceed to place orders on the products and incorporate it into their work-flow.
Precipio’s Laboratory Scientific Director, Ayman Mohamed stated that the process is similar to what the company does when evaluating the introduction of new technology. He asserted that that is the reason they advocate for a rigorous process to enhance the accuracy of results. Depending on the size of the customer the company evaluates the current inventory levels of the lab to ascertain the timeline of finishing the inventory before placing orders.
Tennessee Oncology becomes the first customer
The company has been aggressive in marketing the products and has made inroads in some of the biggest labs locally and internationally. The company has netted its first customer in Tennessee Oncology’s Lab. The lab has already validated the test and plans to perform the HemeScreen Assay within the lab as a lab-developed test (LDT). The Tennessee laboratory has made an order which Precipio has already delivered.
Tennessee Oncology is one of the largest cancer specialists in the country. It runs full diagnostic services including HemeScreen. Precipio expects to generate revenues of around $750,000 annually from Tennessee oncology alone. The company hopes to get another 50 customers the same size as Tennessee Oncology for their HemScreen Assay.