The U.S. Patent and Trademark Office Grants BioMark Patent That Expands Its Claims Covering Its Legacy Liquid Biopsy Assay

The new patent granted by the USPTO strengthens and expands BioMark's global IP portfolio in liquid biopsy, enhancing cancer management solutions.

Vancouver, British Columbia--(Newsfile Corp. - July 31, 2024) - BioMark Diagnostics Inc., (CSE: BUX) (FSE: 20B) (OTC Pink: BMKDF) ("BioMark" or the "Company"), a leading developer of liquid biopsy tests for early detection of hard-to-detect and treat cancers, is pleased to announce the issuance of U.S. Patent No. 17/895.69 by the U.S. Patent and Trademark Office (USPTO). This patent protects the company's Spermidine/spermine N(1)-acetyltransferase 1 (SAT1) legacy assay platform for assessing tumor velocity and treatment response, particularly in glioblastoma patients (GBM) and triple-negative breast cancer (TNBC) patients with specific genetic mutations.

"We are thrilled to announce the issuance of this new patent, underscoring our commitment to advancing liquid biopsy technology for patients with especially challenging cancers," said Rashid Bux, CEO and President of BioMark. "By expanding our patent estate and initiating new research initiatives, we are positioning BioMark as a leading player in the fight against cancer. The successful outcome of these developments will enhance our role in delivering needed solutions in cancer management, ultimately aiming to save lives and improve the quality of patient care."

Glioblastoma Multiforme (GBM)

• Glioblastoma multiforme (GBM) is the most common type of primary brain tumor in adults. As a grade IV astrocytoma, GBM is highly invasive and aggressive. Current treatments, including surgical resection, radiation, and chemotherapy, yield a median survival time of 15 months. There is a pressing need to develop novel strategies for treating GBM, quickly assess tumor velocity, and effectively monitor treatment response.
• GBM is relatively rare, with an incidence of about 3.2 per 100,000 people globally each year, translating to approximately 13,000 new cases annually in the United States alone (National Brain Tumor Society).
• The Glioblastoma Multiforme Treatment Market size is estimated at USD 2.80 billion in 2024 and is expected to reach USD 4.60 billion by 2029, growing at a CAGR of 8%. *

*Source: https://www.mordorintelligence.com/industry-reports/glioblastoma-multiforme-treatment-market.

Triple-Negative Breast Cancer (TNBC)

• Approximately 1 in 8 women in Canada and the US will be diagnosed with breast cancer in their lifetime. TNBC, the deadliest breast cancer subtype, accounts for about 15% of all breast cancers. Standard treatment is limited to untargeted chemotherapy, though the recent approval of adjuvant-targeted Olaparib for high-risk HER2-negative breast cancer offers an additional option for patients with germline BRCA mutations.
• Metastatic TNBC patients have a median survival of 2 years. Early detection and effective treatment response assessment can provide clinicians with critical information for therapy decisions.
• BioMark plans to launch a preclinical study to evaluate the effectiveness of specific adjuvant treatments in TNBC patients with BRCA mutations using its SSAT1 liquid biopsy. This research aims to generate critical data for future clinical trials and potentially offer clinicians a valuable tool for early treatment response assessment.

"We continue to expand our patent estate related to our legacy assay with additional candidates selected to improve our signal-to-noise ratio linked to our assay performance. This is a timely announcement for BioMark as we set our sights on expanding clinical trials with partners in the US interested in developing molecular assays that can assess response to treatment effectiveness and tumor velocity in both GBM and TNBC patients who harbor specific mutations that make treatment difficult," says Rashid Bux.

BioMark's extensive portfolio of patents covering key products in this market creates shareholder value by providing the company with both the freedom to operate and significant product differentiation.

About Spermidine/spermine N(1)-acetyltransferase 1 (SAT1)

It is an enzyme involved in the polyamine catabolic pathway, playing a critical role in the regulation of polyamine levels within cells. Elevated activity of SAT1 has been associated with increased sensitivity to certain types of cancer treatments, including radiation therapy.

About BioMark Diagnostics Inc.

BioMark is a liquid biopsy company developing a molecular diagnostic technology platform that leverages the power of metabolomics and machine learning algorithms to bring new cancer diagnostics to market and improve cancer prognosis by allowing physicians to detect carcinomas in the presymptomatic stages. The technology can also be used for measuring response to treatment and potentially for serial monitoring of cancer survivors. While the Company current focus is on the commercialization of its liquid biopsy test for early detection of lung, it has plans to expand into other hard-to-detect and treat cancers such as brain, ovarian, and pancreatic.

Further information about BioMark is available under its profile on the SEDAR+ website www.sedarplus.ca and the CSE website https://thecse.com/.

Forward-Looking Information:

This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events, or results or otherwise, other than as required by applicable securities laws.

The CSE has not reviewed, approved, or disapproved the content of this press release.

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