A Close Look at Accustem Sciences Ltd (OTCMKTS: ACUT)

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Accustem Sciences Ltd (OTCMKTS: ACUT) has been on the move over the past few days popping over $1 and trading right below there now. The stock made a nice move last year to highs of $2 from a $0.50 start but drifted back down to current levels since then. 

The Company’s primary product candidate is StemPrintER, a 20-gene prognostic assay intended for the prediction of the risk of distant recurrence (“DR”) in luminal, ER+/HER2-negative breast cancer patients. StemPrintER has been validated in several retrospective cohorts and studies, the largest of which are a consecutive series of approximately 2,400 patients from the European Institute of Oncology (IEO) and approximately 800 patients from the TransATAC study.  

Accustem Sciences Ltd (OTCMKTS: ACUT) is a clinical stage diagnostics company dedicated to optimizing outcomes and quality of life for all patients with cancer. We plan 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, such as tumor “stemness,” we believe our tools will help care teams better understand the biology of each patient’s cancer, leading to more informed decision making.  

AccuStem primary product candidate is StemPrintER, a 20-gene prognostic assay intended for the prediction of the risk of distant recurrence (“DR”) in luminal, ER+/HER2-negative breast cancer patients. StemPrintER has been validated in several retrospective cohorts and studies, the largest of which are a consecutive series of approximately 2,400 patients from the European Institute of Oncology (IEO) and approximately 800 patients from the TransATAC study. These studies all confirm that StemPrintER is highly prognostic for outcomes in patients with breast cancer and indicate the potential utility of the test in the oncology clinic. 

Through a validation study analyzing a large prospective, randomized cohort of breast cancer patients with high-quality follow-up, and a series of retrospective studies based on the use of fresh tumor samples and gene expression profiles from additional breast cancer patients, it has been established that StemPrintER predicts the individual likelihood of developing distant metastases in luminal (ER+/HER2-) and triple negative breast cancers. 

The largest validation study for StemPrintER involved the retrospective analysis of nearly 2,400 breast tumor samples collected through the IEO clinical network. In this published study, StemPrint and StemPrintER were highly prognostic for early and late recurrences in luminal (ER+/HER2-) and triple negative (ER-/PR-/HER2-) breast cancer patients, independent of standard clinical characteristics. In the TransATAC cohort of ER+/HER2- post-menopausal breast cancer patients, a team of scientists from the IEO conducted an independent validation of StemPrintER using banked study samples in collaboration with the Royal Marsden Hospital and Queen Mary University in London.  

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AccuStem’s plan is to launch StemPrintER testing for patients with breast cancer once we have achieved several key milestones. First, the Company is planning to build corporate headquarters in Phoenix, AZ that will also house a clinical laboratory. That laboratory will be responsible for processing, testing and reporting StemPrintER results for all commercial samples. Further, once the laboratory is established,  AccuStem will obtain CLIA certification so that we are able to report results for clinical use and to seek reimbursement from the Centers for Medicare and Medicaid Services. Finally, we will transfer the StemPrintER technology from the laboratory in which it was developed (at the IEO) to our laboratory in Phoenix.  

Last September the US Patent and Trademark Office issued a new patent, No. 11,441,191, further strengthening the company’s foundation of intellectual property for its novel StemPrintER test. The patent, “Methods and Kits Comprising Gene Signatures for Stratifying Breast Cancer Patients,” covers the methodology behind the 20-gene StemPrintER test which stratifies 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. Studies have shown that StemPrintER is highly prognostic, with “high stemness” patients up to 4 times as likely to experience a distant recurrence as “low stemness” patients. 

On December 6 AccuStem announced that its Chairman of the Board, Mr. Gabriele Cerrone, has notified the Company that he has recently purchased an additional 3,729 ACUT shares in the open market. This brings his total holding to 3,859,452 shares. This follows the purhase of 24,500 shares of ACUT in November. 

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ACUT has been on the move over the past few days popping over $1 and trading right below there now. The stock made a nice move last year to highs of $2 from a $0.50 start but drifted back down to current levels since then. ACUTs primary product candidate is StemPrintER, a 20-gene prognostic assay intended for the prediction of the risk of distant recurrence (“DR”) in luminal, ER+/HER2-negative breast cancer patients. StemPrintER has been validated in several retrospective cohorts and studies, the largest of which are a consecutive series of approximately 2,400 patients from the European Institute of Oncology (IEO) and approximately 800 patients from the TransATAC study. We will be updating on ACUT when more details emerge so make sure you are subscribed to investmillion.com by entering your email below.

Disclosure: we hold no position in ACUT either long or short and we have not been compensated for this article.

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