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TEST:
HemeScreen™ Panel

Company:
Precipio
Type:
CE Marked
Related tests:
Evidence

News

10ms
Precipio and Cardinal Health sign distribution agreement for its HemeScreen® portfolio of molecular assays for cancer (Precipio Press Release)
"Specialty cancer diagnostics company Precipio, Inc...announces it has entered into a distribution agreement with Cardinal Health for its HemeScreen molecular assay products...Under the agreement, Cardinal Health will market and distribute Precipio’s HemeScreen portfolio of molecular assays to its customer base, which comprises primarily the acute healthcare systems (hospital networks), as well as reference laboratories and physician owned laboratories."
Licensing / partnership
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HemeScreen™ Panel
10ms
Precipio signs distribution agreement for IV-Cell® and HemeScreen® in Japan (Precipio Press Release)
"Precipio, Inc...announces it has entered into an agreement with a Japanese distributor for the sales and distribution of its products into the Japanese market."
Licensing / partnership
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HemeScreen™ Panel
over1year
Precipio’s Omnia™ methodology enables diagnosis of MDS with peripheral blood instead of bone marrow biopsy (GlobeNewswire)
"Precipio, Inc. leveraged its proprietary HemeScreen Cytopenia panel as part of the diagnostic process for molecular identification of driver mutations in a patient with a history of transfusion-dependent anemia and experiencing progressive weakness and neurological symptoms. The findings point to an underlying myeloid stem cell disorder, including a myelodysplastic syndrome and possibly a higher-grade myeloid neoplasm."
Clinical
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HemeScreen™ Panel
over1year
Precipio enters into collaboration with prestigious New York-based institution to develop revolutionary brain tumor panel using HemeScreen® technology (Precipio Press Release)
"Precipio, Inc...announces that it has entered into a collaboration agreement with a NY-based academic healthcare institution to jointly develop a panel for Glioblastoma (GBM), an aggressive brain cancer based on Precipio’s HemeScreen technology."
Licensing / partnership
|
HemeScreen™ Panel
over1year
Precipio’s lab detects BCR-ABL1 oncogene co-expression of p190 & p210 isoforms in a CML patient by using HemeScreen® technology (Precipio Press Release)
"Specialty cancer diagnostics company Precipio, Inc. leveraged its proprietary HemeScreen technology as part of the diagnostic process to monitor a patient with a history of Chronic Myeloid Leukemia (CML) and p210 isoform expression which allowed the lab to uncover an additional oncogene isoform expression (p190)."
Clinical
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HemeScreen™ Panel
over1year
High-resolution melting assay for rapid, simultaneous detection of JAK2, MPL and CALR variants. (PubMed)
These studies demonstrate the exquisite accuracy, sensitivity and specificity of the HRM-based HemeScreen MPN assay, which serves as a powerful, clinically applicable platform for rapid, simultaneous detection of clinically relevant, somatic disease variants.
Journal
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HemeScreen™ Panel
2years
Precipio presents poster on HemeScreen® study at Association of Molecular Pathology (AMP) 2022 Annual Conference (Precipio Press Release)
"Precipio, Inc...presented at the annual 2022 AMP conference a poster presentation of the results of a groundbreaking study, conducted in collaboration with faculty at the University of Pennsylvania. The study, expected to be published in detail early next year, demonstrates the superior results of Precipio’s HemeScreen® MPN panel when compared to Sanger Sequencing (considered the 'gold standard' of molecular testing)."
Clinical data
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HemeScreen™ Panel
2years
Precipio signs agreement with another major US healthcare distributor for HemeScreen™ (Precipio Press Release)
"Specialty cancer diagnostics company Precipio, Inc...has signed a distribution agreement for HemeScreen with a major distribution partner (name withheld as per partner’s policy). Following an upcoming training program and onboarding of their national coverage, this distribution channel partner’s sales team will begin promoting and driving sales of the HemeScreen platform to hundreds of their current accounts."
Licensing / partnership
|
HemeScreen™ Panel
over2years
Precipio launches new 1-step technology for all HemeScreen assays (Precipio Press Release)
"Precipio, Inc...announces the launch of its second generation of HemeScreen panels. Precipio’s customers using HemeScreen in their laboratory will have the option of upgrading to the 1-step assay, or remaining with the current assay...While the first generation of panels required a 2-step process that included a positive-confirmation step, the new version no longer requires this step. This means that both positive and negative results can be reached at the completion of the assay run within approximately 3 hours."
Launch
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HemeScreen™ Panel
over2years
Precipio to distribute HemeScreen® through Fisher Healthcare channel (Precipio Press Release)
"Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), today announced that it has entered into an agreement with Fisher Healthcare, a part of Thermo Fisher Scientific to distribute its proprietary HemeScreen assays to its customers."
Licensing / partnership
|
HemeScreen™ Panel
over2years
Precipio receives CE-IVD certification to market multiple HemeScreen® panels in Europe (Precipio Press Release)
"Precipio, Inc...announced that it has received CE-IVD approval for sale of its HemeScreen® reagents in the European Union. The approval was provided by the Medicines & Healthcare Products Regulatory Agency...The CE-IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification allows Precipio to market the Hemescreen reagents in the UK and the 27 countries of the European Union (EU)...The panels approved for immediate sale in the EU are the HemeScreen MPN, AML, Anemia/MDS, and CLL panels. "
European regulatory
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HemeScreen™ Panel
over2years
Precipio customer American Oncology Network (AON) selected to present HemeScreen® technology case study at industry leading clinical laboratory conference (Precipio Press Release)
"Precipio, Inc...is excited to announce its participation and the presentation of HemeScreen, its novel diagnostic technology platform, at the Executive War College, organized by publication Dark Daily, the premier laboratory conference, held April 26th through 28th in New Orleans."
Clinical data
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HemeScreen™ Panel
3years
New York State approves Precipio’s HemeScreen for POL clinical use (Precipio Press Release)
"Precipio, Inc...announces that its HemeScreen RUO assay has received the required approval from New York State’s Department of Health (NY DOH). Hemescreen can now be used by New York based physician-owned laboratories (POLs) who apply to run HemeScreen in their lab as a laboratory-developed test (LDT)."
Regulatory
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HemeScreen™ Panel