Precipio (PRPO) Launches New HemeScreen Panel for AML

Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced that it has launched a new, four-hour Acute Myeloid Leukemia (AML) HemeScreen panel to specifically determine the genetics of this aggressive, acute form of leukemia. When physicians are armed with the genetic character of the disease, they can rapidly and precisely select the most effective targeted therapeutic.

Beyond the important clinical utility and substantial impact to patient care described below, this panel is expected to increase revenues to Oncology Physician Office Laboratories (POLs) by approximately 10% (subject to patient volume), and is expected to similarly increase Precipio’s revenues from existing and future Oncology POL and other laboratory customers who incorporate this panel into their operations.

The addition of this panel further demonstrates the potential of HemeScreen and the POL model, whereby an existing installed customer base, as well as Precipio, benefit from the continued development and introduction of new panels by Precipio’s R&D team.

Product Structure

The other panels within the HemeScreen suite of products are offered in multi-sample, pre-plated plates, enabling the testing of multiple patient samples simultaneously (improving efficiencies and reducing costs). Recognizing the acute situation surrounding AML patients and the immediate need for an answer, the AML panel was designed as a single-sample plate.

This means that when a patient presents with severe symptoms that cause suspicion of AML, the office can draw a blood sample and immediately proceed to test the patient for AML, with results that can potentially be obtained as rapidly as approximately 4 hours later. There is no other product or technology in the market that can provide this access to rapid results within a POL setting.

Clinical utility and patient care impact

Acute myeloid leukemia (AML) diagnosis is increasingly based on the underlying genetic characteristics. The evaluation of several gene mutations is now becoming standard of care for diagnosis, prognostic stratification, and differentially tailored treatment strategies1. Furthermore, the importance of correctly identifying the disease and quickly treating patients suspected of having AML makes this HemeScreen panel a valuable tool placed directly in the hands of physicians running these panels in their POL.

The following is a brief outline of the genes tested in Precipio’s new AML panel, and their clinical importance:

1. FLT3: A prognostic marker which may indicate how aggressive the disease is, and can impact the type of chemotherapy selected. 2
2. CEBPA: This mutation is present in approximately 15% of AML patients, and can provide prognostic information to the treating physician.
3. NPM1: Appearing in approximately 50% of AML patient cases (often in conjunction with other AML-associated mutations), NPM1 mutations have been suggested as a monitoring tool for minimal residual disease (MRD). 2
4. IDH1: This mutation is generally associated with decreased complete remission. Leukemias with the IDH1 mutation have a poor prognosis when paired with FLT3. Patients presenting with only the IDH1 mutation have a more favorable outcome. 3 4
5. IDH2: This mutation is generally seen with normal cytogenetics and does not affect overall prognosis. IDH2 mutations can be associated with IDH1 mutation.5
6. KIT: This mutation expression is found in approximately 80% of AML cases. Patients with a KIT mutation have a poor prognosis and clinical outcome, therefore potentially requiring more aggressive treatment. 6

“With patient care at the center of our vision, our R&D team’s abilities to both identify clinically-important testing needs, and design products that address these needs are the backbone of the clinical and commercial success of HemeScreen”, said Ilan Danieli, Precipio’s Chief Executive Officer. “These panels will enable POLs to rapidly identify patient disease and provide immediate, and subsequently better care to their patients in addition to having a positive financial and operational impact on their business. We are excited to see the rollout of the AML and future panels to the market.”

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