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, CT, (September 22nd, 2020) - 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.

To the best of our knowledge, Precipio is the first and only laboratory that can provide same day results that meet the clinical turnaround time requirements for this disease, helping physicians provide immediate and critical care to their patients.

Economic Advantages of HemeScreen

The benefits of HemeScreen AML are first and foremost to ensure that clinicians and their patients receive rapid results critical to their battle with the disease; however, they go beyond the impact to patient care. As part of the HemeScreen product line of assays, HemeScreen AML joins our current HemeScreen MPN panel which includes the important JAK2, MPL and CALR genes. Laboratories and physician office labs (POLs) can run the test in house and generate revenue otherwise foregone by sending these tests out.

This also means that laboratories (whether reference laboratories or physician office labs) who have adopted the HemeScreen platform, may now add this additional panel to their existing testing menu with no additional capital investment.

Furthermore, the panel is designed to test as few as one or two patient samples, while still providing the laboratory with attractive economics. Laboratories using HemeScreen no longer need to “hold” patient samples in order to fill a batch and satisfy economic requirements, impacting patient care. With the HemeScreen AML panel, laboratories can test that patient sample individually, on the same day the sample is received, providing both immediate clinical value while maintaining attractive economics.

Precipio will offer the test in two methods:

          1. As a set of reagents

          2. As a pre-plated assay (eliminating the majority of tech time and labor for sample prep)

For more information on this test, please email us at hemescreen@precipiodx.com; contact us at 203.787.7888 or visit our website at www.precipiodx.com/hemescreen.

“For years laboratories have been forced to choose economics over patient care in order to provide a service that is financially sustainable. HemeScreen removes the need to make that choice”, said Ilan Danieli, Precipio’s CEO“. I’m proud of our R&D team which continues to develop these groundbreaking technological tools, routed in the advancement of patient care. Making these panels available not only to our oncology customers in our CLIA laboratory, but also for broad use through our reference labs and POL customers, ensures a broad impact on tens of thousands of patient’s lives”.

About Precipio

Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.

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