Precipio Launches its Proprietary HemeScreen AML (Acute Myeloid Leukemia) Molecular Panel

Panel of clinically critical genes can yield same-day results outperforming major competitors

NEW HAVEN, Conn., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced today that it has launched its HemeScreen AML (Acute Myeloid Leukemia) panel both clinically in its CLIA laboratory, and as part of its HemeScreen product offering. This new panel expands the HemeScreen offering for reference laboratories and physician office laboratories, enabling them to provide improved patient care through faster turnaround time.

Molecular testing for AML

Acute Myeloid Leukemia (AML) is one of a group of highly aggressive, potentially fatal leukemias, and perhaps one of the most aggressive leukemia, with a 5-year survival rate of approximately 25%¹. Therapy can be effective and the determination of a treatment plan is significantly influenced by the patient’s molecular profile. There is an extreme urgency in rapidly and accurately determining the molecular profile for patients suspected of having AML in order to decide on the course of treatment.

Among the key genes that comprise the molecular testing for AML and are part of Precipio’s HemeScreen AML Panel are IDH1, IDH2, FLT3 and KIT mutations. These genes provide diagnostic, prognostic, and therapeutic information critical to the treating physician in preparing the patient’s treatment plan.

Test Economics and Turnaround Time challenges

For AML patients, time to treatment is critical. In a study published in the Journal of Clinical Pathways in 2018, patients treated within 4 days of diagnosis and admission to the hospital more than doubled their overall survival (OS) time compared to patients who were treated after 4+ days. This is one of many studies that demonstrate the important clinical need for laboratories to provide fast results to patients. However a survey conducted by Precipio found that some of the largest reference laboratories in the US took 7-14 days to deliver results for molecular testing for AML.

One reason for the delay in turnaround time at large reference labs is based on the economics of running these molecular tests - high cost of reagents, complex technical work, and expensive machinery. Because of these reasons, laboratories batch patient samples in order to achieve economies of scale. This means that when the first sample is received, the lab will “hold” the sample, and wait until more patient samples arrive. Once a certain number of samples is received, only then will all samples be batched and tested together. This results in significant delays in laboratories delivering testing results and thus impact patient care.