Over a week ago | ||||
Precipio (PRPO) announced… Precipio (PRPO) announced that it has entered into an agreement with Fisher Healthcare, a part of Thermo Fisher Scientific (TMO) to distribute its proprietary HemeScreen assays to its customers. |
Over a month ago | ||||
Precipio announced that… Precipio 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 certification allows Precipio to market the HemeScreen reagents in the UK and the 27 countries of the European Union. It also enables market development across much of the rest of the world. The CE mark provides quality assurance for the HemeScreen panels validating that the panels meet the essential requirements of the European In-Vitro Diagnostics Directive. The panels approved for immediate sale in the EU are the HemeScreen MPN, AML, Anemia/MDS, and CLL panels. The combination of these panels comprises more than 70% of the hematologic malignancies, and provide a robust solution for hematology/oncology laboratories wishing to deliver faster, more accurate results in a simplified and more economical workflow. |
Over a quarter ago | ||||
Precipio announced that… Precipio announced that American Oncology Network of Fort Myers, Florida, has completed its validation of Precipio's proprietary IV-Cell culture media, and will adopt the product for use in its clinical cytogenetics laboratory. | ||||
Management holds a… Management holds a Q4-2021 and year-end shareholder update conference call on April 4 at 5 pm. Webcast Link | ||||
Management holds a… Management holds a Q4-2021 and year-end shareholder update conference call on April 4 at 5 pm. Webcast Link | ||||
Management holds a… Management holds a Q4-2021 and year-end shareholder update conference call on April 4 at 5 pm. Webcast Link | ||||
Precipio announced that… Precipio announced that Carl Iberger, Precipio's CFO for the past five years, is resigning as the CFO effective as of today, March 21. Iberger wishes to spend more time with his family and therefore has made the decision to step down from his role as CFO. Matt Gage, who currently serves as Director of Financial Reporting and Analysis has been promoted to interim CFO of the company effective immediately. Gage joined Precipio following its acquisition of Transgenomic in July of 2017. | ||||
Precipio announces that… Precipio announces that its HemeScreen RUO assay has received the required approval from New York State's Department of Health. Hemescreen can now be used by New York based physician-owned laboratories who apply to run HemeScreen in their lab as a laboratory-developed test. New York State's DOH is considered one of the strictest regulatory bodies in the US; laboratories interested in setting up and running new assays must submit comprehensive validation data demonstrating the accuracy, efficacy, reliability, and reproducibility of those assays. New York State's DOH conducts an in-depth, rigorous analytical review of the various aspects of the assay and ultimately, if acceptable, provides the submitting laboratory with approval to run the test. Precipio's first customer in NY State, New York Cancer & Blood Specialists embarked on this process earlier this year. It conducted the relevant tests, submitted the required data and responded to numerous rounds of information requests from the NY DOH related to the assay. Now that the process for submitting for NY DOH approval has been established, other POLs in New York State can apply and submit for approval to run HemeScreen in their labs. The launch of our Hemescreen assay by a reputable group such as NYC&B will serve as a powerful case study for other POLs to follow suit. Given the size of the POL practice, the number of doctors, the practice's estimated sample volume, and the potential panels they will use, Precipio estimates that New York Cancer & Blood can potentially generate seven-figure revenues for Precipio. In addition to AON, a Florida-based customer that also recently began running HemeScreen, these two customers alone could provide a substantial revenue increase for Precipio, and a substantial reduction of the company's cash burn. | ||||
Management holds a 2Q2021… Management holds a 2Q2021 shareholder update conference call on August 26 at 5 pm. | ||||
Precipio and American… Precipio and American Oncology Network announces the signing of an agreement under which AON will adopt Precipio's HemeScreen technology and begin running HemeScreen in its central laboratory located in Fort Myers, Florida. AON will be the largest Physician Owned Laboratory to bring HemeScreen into their laboratory thus far. With over 100 physicians, and serving close to 100,000 unique patients annually, the impact to patient care will be substantial. Running HemeScreen in-house will enable AON to shorten diagnostic turnaround time of these tests from 2-4 weeks, to as fast as 1-4 days when run in house. This multi-year agreement will provide Precipio with seven-figure revenue per year. As Precipio continues to develop additional panels, AON will have an opportunity to further broaden the suite of assays run utilizing the HemeScreen technology. |