ACCUSTEM SCIENCES Stock Price, News & Analysis

AccuStem Sciences, Inc. (OTCQB: ACUT) is described as a clinical stage diagnostics company dedicated to improving outcomes and quality of life for patients with, or at risk of, cancer. The company focuses on proprietary molecular testing that aims to address unmet clinical needs across the cancer care continuum, from screening through treatment and monitoring. AccuStem emphasizes interrogating novel disease pathways, including tumor "stemness," to help care teams better understand the biology of each patient’s cancer and support more informed decision making.

According to company disclosures and news releases, AccuStem’s work sits at the intersection of biotechnology research and clinical diagnostics. Its tests are designed to generate clinically relevant information from blood or tumor samples that can guide risk stratification, treatment planning, and follow-up strategies. The company’s activities align with the broader field of research and development in biotechnology, particularly in oncology-focused diagnostics.

StemPrintER test and tumor "stemness"

AccuStem highlights the StemPrintER test as part of its portfolio. In a pilot study agreement with the National Surgical Adjuvant Breast and Bowel Project (NSABP), the company describes StemPrintER as a test that interrogates 20 genes to stratify patients with early stage breast cancer according to their recurrence risk. The test is designed to measure the "stemness" of tumors, or how much they behave like stem cells, which may indicate the likelihood of cancer progression and response to standard treatment modalities.

Company communications state that studies have shown StemPrintER to be highly prognostic, with patients classified as "High Stemness" reported to be more likely to experience distant recurrence than those classified as "Low Stemness." AccuStem and NSABP intend to evaluate StemPrintER in a subset of patients from the B-32 cohort to explore its predictive capabilities in the surgical setting, particularly for women with early stage breast cancer who underwent different lymph node management strategies.

MSC test and lung cancer risk assessment

Another central focus for AccuStem is its MicroRNA Signature Classifier (MSC) test, a non-invasive blood-based assay designed to assess the risk of lung cancer in people who qualify for low-dose computed tomography (LDCT) screening or who have an indeterminate pulmonary nodule detected via imaging. As described in an SEC Form 8-K and multiple news releases, the MSC test analyzes a panel of 24 circulating microRNAs (miRNAs) in plasma to classify nodules as Low or High Risk for malignancy.

The company states that this classification is intended to help clinicians more accurately understand a patient’s cancer risk. By providing additional information beyond imaging alone, the MSC test may potentially reduce unnecessary invasive procedures, such as biopsies or surgery, for benign nodules, while prioritizing higher-risk patients for further evaluation. AccuStem reports that the MSC test has been extensively validated in thousands of patients across multiple prospective trials and that published data support its ability to improve the performance of LDCT screening.

Partnerships and operational deployment

AccuStem has announced a partnership with EmeritusDX, a cancer diagnostics and information company, to expand blood-based testing capabilities and support the commercialization of the MSC test for lung cancer screening. As part of this collaboration, EmeritusDX has installed technology to enable high-throughput extraction of microRNAs from blood samples, which is described as a key step in supporting the MSC assay.

Under the expanded agreement with EmeritusDX, AccuStem outlines plans for operational deployment of the MSC test and a launch into U.S. clinics, as well as efforts to pursue reimbursement strategies that would support broader access. The partnership leverages EmeritusDX’s laboratory and commercial infrastructure together with AccuStem’s diagnostic technologies.

Clinical collaborations and evidence generation

AccuStem’s disclosures emphasize collaboration with clinical research networks to further validate its tests. For lung cancer screening, the company has entered into a development agreement to access blood samples from the multi-institutional, prospective, randomized Rete Italiana di Screening Polmonare (RISP) clinical trial. This agreement is intended to further demonstrate the impact of the MSC test in the lung cancer screening setting and to provide statistical and analytical support and subject matter expertise as AccuStem works to establish and commercialize the test in the United States.

The company also references prior research, including the MILD trial, which it cites as demonstrating that the MSC test in combination with LDCT has the potential to reduce the false positive rate of LDCT alone by a factor of five. AccuStem positions these data as evidence that combining molecular signatures with imaging may better triage patients diagnosed with lung nodules, improve outcomes, and reduce costs to the healthcare system.

Reimbursement pathway and regulatory context

In an SEC filing, AccuStem reports that, to establish reimbursement for the MSC test, it has submitted an application for a local coverage determination with Novitas Solutions, a Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services for a specific region. Novitas has informed the company that the application was determined to be complete and valid and would enter the review queue. This disclosure highlights AccuStem’s focus on integrating its diagnostics into established reimbursement frameworks.

Business focus and sector classification

Across its public communications, AccuStem consistently describes itself as a clinical stage diagnostics company within the broader area of research and development in biotechnology. Its stated goal is to offer proprietary molecular tests that address unmet clinical needs in oncology. The company emphasizes cancer screening, treatment planning, and monitoring as key application areas for its technologies, with a particular focus on understanding tumor biology through markers such as tumor stemness and circulating microRNAs.

AccuStem’s activities align with the Professional, Scientific, and Technical Services sector, reflecting its emphasis on scientific research, diagnostic test development, and collaboration with clinical and laboratory partners. Public statements also note that AccuStem is quoted on the OTCQB market under the symbol ACUT.

Geographic footprint and investor communications

Company news releases reference Phoenix, Arizona and London in datelines, indicating a presence in both the United States and the United Kingdom. AccuStem participates in investor-focused events, such as virtual life sciences investor forums, where it presents its diagnostic portfolio and discusses how its tests aim to address clinical questions in oncology.

In several announcements, AccuStem reports open-market share purchases by its Chairman of the Board, indicating insider ownership and ongoing engagement with the company’s equity. These communications are part of the company’s broader investor relations activities and are disseminated through established newswire services.

How AccuStem describes its mission

In the "About AccuStem" sections of its releases, the company states that it plans to drive innovation in healthcare by offering proprietary molecular testing that addresses unmet clinical needs from cancer screening through treatment and monitoring. By interrogating novel disease pathways, including tumor stemness, AccuStem believes its tools will help care teams better understand the biology of each patient’s cancer, leading to more informed decision making. This mission statement provides context for the development of tests such as StemPrintER and MSC and for the company’s collaborations with clinical research groups and diagnostic laboratories.