Bioworld: Precipio launches Hemescreen anemia panel

June 8, 2021

By Meg Bryant

Precipio Inc. reported the launch of its Hemescreen anemia panel, part of a suite of diagnostic tests that run on the Hemescreen physician office laboratory (POL) testing system. The new panel is intended to help physicians tackle a difficult challenge – deciphering anemias of unknown cause.

According to the World Health Organization, an estimated 1.62 billion people – 24% of people worldwide – have anemia. In the U.S., the number is about 3 million. The condition leads to reduced oxygen flow to the body’s organs, resulting in fatigue, weakness and other symptoms.

While anemia is characterized by low volume of red blood cells, multiple factors can cause the disorder. Among these are bleeding, poor nutrition, iron deficiencies, inherited diseases and cancer. Determining what is causing a patient’s anemia is key to deciding how best to treat it.

Same-day results

Current tests for anemia, such as complete blood count, shed light on the makeup of the blood but offer no clues on a possible genetic cause. Next-generation sequencing does test for genes, but is expensive and can take weeks to get results.

In contrast, the Hemescreen anemia panel looks at genes linked to anemia in bone marrow diseases and delivers results the same day.

Genes tested in the targeted panel include: ASXL1, a mutation seen in myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), chronic myelomonocytic leukemia (CMML), refractory anemia and acute myeloid leukemia (AML); DNMT3A, a mutation seen in AML and DMS; RUNX1, a mutation commonly seen in chemotherapy related MDS, as well as in AML and AML after DMS; TERT, a mutation variant seen in AML, MDS and MPN; and WT1, a mutation that can result in higher relapse rates and poorer outlook in patients with AML.

“The anemia panel provides a unique tool that enables physicians to differentiate the root causes of a common blood disorder symptom and deliver immediate care to those who may be at risk of cancer,” said Ilan Danieli, CEO of the New Haven, Conn.-based company.

Expanding test menu

The launch follows last month’s rollout of a four-hour acute myeloid leukemia panel to reveal the genetic sources of this aggressive form of leukemia. The test enables physicians to draw a blood sample and quickly test for five mutations and one prognostic marker when a patient presents with severe symptoms suggesting the likelihood of AML.

The company also markets a MPN panel for Hemescreen and is developing a panel for chronic lymphocytic leukemia.

The anemia panel has the potential to boost revenues of oncology POLs by 25%, and could have a similar impact on its own revenues, Precipio said. In April., the specialty diagnostics company said it expected current customers to generate $1 million in annualized reported revenues by the fourth quarter of 2021, and account for 50% of its pathology revenues. At the time, Hemescreen revenues exceeded $750,000.

The Hemescreen platform commercially launched in 2018 as a test for hematologic cancers. The test was initially offered in Precipio’s New Haven laboratory and via research-use-only reagents sold to reference labs with CLIA-certified facilities.

In March, the company transitioned Hemescreen from the R&D space to commercial laboratories with a reagent rental program that provides the assays with an option to rent-to-own the company’s diagnostic testing equipment.

“Precipio’s R&D team continues to produce products that leverage our proprietary Hemescreen technology, generating clinical utility as well as economic benefit to Precipio and its customers,” Danieli said. “We look forward to this panel joining the other products in the Hemescreen suite of diagnostic tools.”

For the first quarter of 2021, Precipio reported revenue of $1.82 million, up 50% from the same period the prior year. Earnings per share were -$0.08, up 89.74% year over year.

Precipio shares (NASDAQ:PRPO) soared Tuesday on news of the Hemescreen anemia panel, closing up 18.47% at $4.17.