Initial study will enable further collaboration on the predictive capabilities of StemPrintERPHOENIX, Jan. 08, 2026 (GLOBE NEWSWIRE) -- AccuStem Sciences, Inc. (OTCQB: ACUT), a clinical stage diagnostics company dedicated to improving outcomes for patients with or at risk of cancer, today announced the execution of a pilot study agreement with NSABP to evaluate StemPrintER in a subset of patients from the B-32 cohort. This evaluation will enable the two groups to then confirm the predictive capabilities of ...

Core Insights - Precipio, Inc. is set to present findings from a joint study with Memorial Sloan Kettering Cancer Center, highlighting the positive impacts of its BCR::ABL1 assay on patient care [1][2] Group 1: Study Findings - The comprehensive study involved 895 patient samples and demonstrated superior performance of the BCR::ABL1 assay, showing concordance with two other leading platforms [2] - The study indicates clear, positive impacts on patient care and significant improvements in laboratory workflows [2] Group 2: Company Overview - Precipio is a healthcare biotechnology company focused on cancer diagnostics, aiming to address cancer misdiagnoses through innovative diagnostic products and services [3] - The company's mission includes delivering higher accuracy and improved laboratory workflow, ultimately leading to better patient outcomes and reduced healthcare expenses [3]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive has a strong focus on technology adoption, utilizing decades of expertise and experience among its content creators [4] - The company employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Company Overview - Precipio, Inc. is a healthcare biotechnology company focused on cancer diagnostics, aiming to address cancer misdiagnoses through innovative diagnostic products and services [3] - The company's mission includes delivering higher accuracy, improving laboratory workflow, and enhancing patient outcomes, which ultimately reduces healthcare expenses [3] Upcoming Corporate Update - Precipio will host its Q3-2025 corporate update call on November 17, 2025, at 5:00 PM ET, providing updates on its current core businesses [1] - Interested listeners can submit questions in advance via email, and a replay of the call will be available approximately 24 hours after the event [2] Communication Channels - Precipio encourages stakeholders to visit its website and follow its social media channels for updates, disclosures, and other material information [4]

Financial Performance - Total revenue in 3Q25 reached $851 million, a 20% year-over-year increase[5] - Adjusted EBITDA in 3Q25 was $135 million, up 37% year-over-year[5] - Core revenue grew by 20% in 3Q25[7] - Screening revenue increased by 22% from $545 million in 3Q24 to $666 million in 3Q25[8] - Precision Oncology core revenue increased by 12% from $163 million in 3Q24 to $183 million in 3Q25[8] - Adjusted EBITDA margin improved to 16% in 3Q25, a 200 basis points increase from 14% in 3Q24[11] Guidance Update - Total revenue guidance for 2025 was updated to $3220-$3235 billion, an increase of $78 million at the midpoint[13] - Screening revenue guidance for 2025 was updated to $2510-$2520 billion, an increase of $60 million at the midpoint[13] - Precision Oncology revenue guidance for 2025 was updated to $710-$715 million, an increase of $18 million at the midpoint[13] - Adjusted EBITDA guidance for 2025 was updated to $470-$480 million, an increase of $10 million at the midpoint[13]

Core Viewpoint - Precipio, Inc. has reported continued revenue growth across its divisions, improved gross margins, and is on track to achieve cash flow positivity and a debt-free balance sheet by the end of 2025 [2][3]. Financial Performance - Q2-2025 revenues reached $5.7 million, a 27% increase year-over-year from $4.4 million in Q2-2024, and a 15% increase quarter-over-quarter from Q1-2025 [7]. - Pathology Services revenue increased by approximately $0.75 million, or 17%, from $4.25 million in Q1-2025 to $5.0 million in Q2-2025 [6]. - Adjusted EBITDA for Q2-2025 was ($78,000), a significant improvement of 87% compared to ($609,000) in Q2-2024 [7]. Products Division - The Products Division experienced a strong rebound in revenues, driven by the return of two customers to full operational volume and the onboarding of a new customer [4]. - Organic revenue growth was noted from existing customers expanding their test offerings with new HemeScreen panels [5]. Pathology Services Division - The Pathology Services Division achieved revenue growth through the acquisition of new customers and increased volume from existing customers, with no substantial capital expenditures anticipated to support this growth [6]. - Gross margins for the Pathology Services Division increased year-over-year from 37% to 43% due to increased case volume and a more profitable case mix [8]. Gross Margins and Operating Expenses - Overall gross margins improved year-over-year from 39% to 43% [9]. - Product division gross margins were 44% in Q2-2025, down from 50% in Q2-2024, attributed to increased rent and depreciation expenses due to expansion and equipment purchases [8]. Cash Flow and Debt Management - Cash used by operations decreased from $516,000 in Q2-2024 to $148,000 in Q2-2025, marking a 71% improvement year-over-year [7]. - The company is expected to complete the repayment of the Change Healthcare loan by the end of the year, contributing to a strong balance sheet [2]. Future Outlook - Management believes the company is on track to end the year as a cash flow positive business with a strong balance sheet [2]. - A quarterly shareholder call is scheduled for August 14, 2025, to provide further details on performance and outlook [12].

Core Insights - Precipio, Inc. reported strong financial performance in Q1-2025, with a 43% year-over-year revenue increase, reaching $4.9 million [9][10] - The company anticipates continued revenue growth and a return to positive operating cash flow by Q2 or Q3 of 2025, driven by momentum in its Product business and expanded reimbursement opportunities in Pathology Services [2][8] Financial Performance - Q1-2025 revenues increased by 43% year-over-year, but decreased by 9.5% from Q4-2024 due to seasonal factors and onboarding delays [9] - Adjusted EBITDA improved significantly to ($108K) from ($1,409K) year-over-year, marking a 92% improvement [9] - Cash used in operations decreased to ($44K) in Q1-2025 from ($667K) in Q1-2024, an improvement of 93% [9] Product Division Highlights - The Products Division onboarded one new customer and launched two new panels in Q1-2025, with expectations for increased orders in Q2 [5] - Gross margins for the Products Division increased from 37% to 51% year-over-year [10] Pathology Services Division Highlights - Pathology Services revenues grew 54% year-over-year, with test volume increasing by 46% [7] - The division received MolDx approval for NGS testing, allowing Medicare billing, which is expected to positively impact future revenues [7] Operational Efficiency - Operating expenses as a percentage of net revenue decreased from 87% to 61% year-over-year, with management maintaining flat operating expenses at approximately $3 million per quarter [9] - Overall gross margins improved from 27% to 43% year-over-year, with expectations for continued growth as the revenue mix shifts towards more product sales [10]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $114.5 million, representing an 18% year-over-year growth, driven by testing revenue growth of 19% year-over-year [5][28] - Adjusted EBITDA margin was 21.6%, significantly higher than expected, with a strong balance sheet of $287 million in cash and short-term investments [5][28] - Non-GAAP gross margin was 72%, up approximately 400 basis points year-over-year, while testing gross margin was 74%, up approximately 200 basis points [30][32] Business Line Data and Key Metrics Changes - Decipher testing revenue grew by 33% year-over-year, with volume growth of 37%, totaling approximately 22,600 tests [6][28] - Afirma testing volume increased by 10% year-over-year, resulting in approximately 15,500 tests, but revenue growth was lower due to prior period collection benefits [12][28] - Product line revenue was $3.6 million, up 1% year-over-year, while biopharmaceutical and other revenue was also $3.6 million, up 19% year-over-year [29] Market Data and Key Metrics Changes - The company reported a record number of ordering providers for Decipher, up over 20% from the prior year, indicating strong market penetration [6][28] - The Decipher prostate metastatic test is expected to launch broadly in June 2025, expanding the population eligible for testing [9][10] - The MRD platform is advancing with a focus on muscle invasive bladder cancer, with commercial launch expected in the first half of 2026 [18][19] Company Strategy and Development Direction - The company is focused on expanding its existing tests, Decipher and Afirma, and launching new products like Prosigna in the U.S. breast cancer market [16][17] - Strategic initiatives include international expansion and addressing novel cancer challenges with innovative products [6][25] - The company aims to leverage its Veracyte Diagnostics platform to generate clinical evidence and support product adoption [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering strong growth despite a challenging macro environment, citing positive trends in testing volume and provider engagement [5][6] - The company reiterated its 2025 testing revenue guidance of $470 million to $480 million, raising adjusted EBITDA margin guidance to 22.5% [33][34] - Management emphasized the importance of evidence generation and reimbursement for new product launches, ensuring organizational readiness for upcoming launches [48][52] Other Important Information - The company is undergoing a bankruptcy process for its French subsidiary, Veracyte SAS, which will not impact its overall strategy or revenue models for the next five years [21][24] - The launch of the Prosigna LDT is expected to begin in mid-2026, targeting a significant market of over 300,000 breast cancer patients annually in the U.S. [16][17] Q&A Session Summary Question: Thoughts on portfolio optimization and pipeline value of MRD and nasal swab - Management is focused on portfolio management, ensuring investments have appropriate evidence and reimbursement, and is excited about the broad pipeline of new products [37][40] - The MRD and nasal swab initiatives are seen as having significant market potential, with upcoming milestones expected to validate their value [42][43] Question: Organizational readiness for upcoming product launches - The company has a thoughtful launch plan in place, ensuring that investments are made in line with growth opportunities and that commercial activities are well-prepared [48][52] Question: Clarification on guidance and growth expectations for Afirma - Afirma is expected to see high single-digit revenue growth for the year, with volume growth driven by prior period collections and market dynamics [66][67] Question: Differentiation of Prosigna in a competitive market - Management believes Prosigna is differentiated based on evidence generation and a strong playbook similar to Decipher, aiming to gain market share in the U.S. [73][75]

As filed with the Securities and Exchange Commission on September 20, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 bioAffinity Technologies, Inc. (Exact name of registrant as specified in its charter) | Delaware | 8731 | 46-5211056 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Co ...