Precipio Launches Its Much-Anticipated Quantitative BCR-ABL 2.0 Panel
Advanced panel already generating six-figure pre-orders
NEW HAVEN, Conn., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), announces the launch of its new quantitative BCR-ABL 2.0 panel, with features making it the most innovative panel of its kind on the market. For more information on this new panel please visit us at https://tinyurl.com/QBCR-ABL1.
Patients with Chronic Myeloid Leukemia (CML) have cells which contain an abnormal gene, BCR-ABL1. This gene creates a hybrid protein that results in uncontrolled cell division and genomic instability1. The presence of the BCR-ABL1 oncogene confirms the diagnosis of CML; it is also used for the monitoring of patients to gauge their response to various therapies, and therefore is frequently tested in laboratories.
The following features make this product the most advanced BCR-ABL panel on the market, besting competition in terms of robust coverage, workflow ease, accuracy, and cost:
1. Industry leading clinical coverage improves patient care. Precipio’s HemeScreen BCR-ABL 2.0 assay is the only panel on the market that provides quantitative coverage of four clinically relevant2,3 breakpoints – p.190, p.210, p.203 and p.230. Most other products offer only single breakpoint detection. To the patient, this means a higher level of accuracy by providing broader testing coverage, ensuring they are put on the correct treatment.
2. ABL1 mutation detection removes the need for an additional testing step. Upon finding a positive result, labs may reflex to ABL1 sequencing to determine point mutations that may impact treatment decisions. Precipio’s 2.0 assay will identify point mutation clusters associated with specific therapeutic indications, enabling a lab to bypass this additional step.
3. Unparalleled workflow simplicity reduces labor time and cost. As with all HemeScreen assays, the reagents come in either pre-plated reagents, or in free-flow form, with all components pre-mixed. This creates unmatched simplicity for the lab staff by avoiding mixing and pipetting reagents, and all that is required is to pipette the extracted sample into the pre-plated wells.
Furthermore, the new BCR-ABL 2.0 panel will come with an automated analysis software which will provide a direct analysis result that can be streamlined directly into the laboratory’s LIS (lab information system) or the practice’s EMR (Electronic Medical Records) system, removing the manual analysis step and saving time and labor cost.
4. Superior sensitivity provides higher accuracy. Precipio’s BCR-ABL assay can detect gene mutations as infrequent as 1 in 100,000. This is twice as sensitive as the next most sensitive qPCR assay on the market.
By essentially becoming a 1-stop platform for all molecular testing for blood related cancers, HemeScreen has demonstrated its value to laboratories looking to increase their offering while consolidating and simplifying their workflow.
“The desire to continuously improve our products and innovate our technologies, guided by delivering the best diagnostic tools to benefit patient care, is at the core of our R&D team, and is exemplified in this new panel,” said Ilan Danieli, CEO of Precipio”. Laboratories will not only be able to deliver better, more accurate results to the patients they serve; they will be able to do so with an easier workflow and more attractive economics, thereby hitting the diagnostic product trifecta. We are excited to see this product enter the market and help accelerate the market penetration for HemeScreen, and our revenue growth.”
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, as well as proprietary products that serve laboratories worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment, 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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Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, among others, statements related to the expected or potential impact of the novel coronavirus (COVID-19) pandemic, and the related responses of the government, consumers, and the company, on our business, financial condition and results of operations, and any such forward-looking statements, whether concerning the COVID-19 pandemic or otherwise, involve risks, assumptions and uncertainties. Except for historical information, statements about future volumes, sales, growth, costs, cost savings, margins, earnings, earnings per share, diluted earnings per share, cash flows, plans, objectives, expectations, growth or profitability are forward-looking statements based on management’s estimates, beliefs, assumptions and projections. Words such as “could,” “may,” “expects,” “anticipates,” “will,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “predicts,” and variations on such words, and similar expressions that reflect our current views with respect to future events and operational, economic and financial performance, are intended to identify such forward-looking statements. These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed. Important factors that could affect performance and cause results to differ materially from management’s expectations, or could affect the company’s ability to achieve its strategic goals, includes factors that are described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis” in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as updated from time to time in the company’s Securities and Exchange Commission filings.
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1 www.cancer.org
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6498709/
3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2193055/
