A peer-reviewed article confirms that Qualigen’s FastPack® is


CARLSBAD, Calif., Oct. 19, 2021 (GLOBE NEWSWIRE) – Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a biotechnology company focused on developing treatments for adult and pediatric cancers with orphan drug designation potential, announces today the publication of a study in the open source peer-reviewed journal, Diagnostic, validating the FastPack of the Company’s point of service® IP diagnostic test (“FastPack”) comparable to a state-of-the-art laboratory method for determining thyroid stimulating hormone (TSH) levels in the blood.

This study, which was supported by the company’s marketing partner, SEKISUI Diagnostics, provides further validation after years of field evidence demonstrating the accuracy and reliability of FastPack compared to laboratory tests for the same application, but while also providing patients and providers with the speed and convenience of a point-of-care setting.

“FastPack technology has been used successfully for over two decades, and up-to-date real-world clinical evidence is an important pillar in our understanding of its accuracy and usefulness in the marketplace. This study, which was conducted in a cohort of 100 subjects in Foggia, Italy, corroborates what endocrinologists, diabetologists, and general and internal medicine clinicians have been through for many years – that FastPack IP provides an easy solution to Useful, rapid, reproducible – and very accurate – tests for TSH levels, which is essential for prescribing and evaluating treatments, ”commented Michael Poirier, CEO of Qualigen.

The Diagnostic study, entitled “Comparison between an Emerging Point-of-Care Tool for TSH Evaluation and a Centralized Laboratory-Based Method in a Cohort of Patients from Southern Italy”1 demonstrated a strong correlation between FastPack TSH results and those from laboratory analyzes. Additionally, subjects who participated in the study were used to having TSH tests 3-5 times a year and expressed complaints about the time it took to receive lab results. All of the patients who participated in the study noted the benefit of the shorter time to results provided by FastPack.

The study protocol required investigators to collect serum from 72 patients and 28 control subjects who took a single blood sample at a central laboratory to assess TSH values ​​using the FastPack against the Beckman ACCESS2 instrument. Coulter. Investigators were able to easily get results much faster with FastPack (in about 15 minutes) as opposed to the 2 day response time required by Beckman ACCESS2.

“We have spent many years working with Qualigen and are very pleased to see the clinical performance, value and utility of the FastPack platform demonstrated in the real world through this comprehensive scientific study,” said Lee Lipski , Sr. VP IVD Business Unit, SEKISUI Diagnostics.

Sales of Qualigen’s FDA-approved FastPack System diagnostic instruments and test kits have exceeded $ 100 million since their inception and have been used successfully in diagnostics for over 20 years. FastPack provides fast and accurate immunoassays for prostate cancer, men’s health, hormonal function, PSA, testosterone, thyroid disorders, pregnancy, and vitamin D status.

On Qualigenic Therapeutic, Inc.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing treatments for adult and pediatric cancers with orphan drug designation potential, as well as maintaining and expanding its FDA-approved FastPack core.® System successfully used in diagnostics for 20 years. Qualigen’s aptamer platform, of which QN-247 is the lead candidate, inhibits nucleolin, a key multifunctional regulatory protein that is overexpressed in cancer cells, thereby influencing their proliferation, survival and metastasis. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). Qualigen’s RAS-F platform is a family of small molecules that inhibit RAS oncogenic protein-protein interactions believed to interfere with cancer gene pathways that cause tumor formation. Such a mechanism of action may be effective in treating about a quarter of all cancers, including some forms of pancreatic, colorectal and lung cancer. The RAS pathway has generated considerable interest due to recent groundbreaking developments in the field and the first clinical approval earlier this year for a drug directed against K-RAS. In addition to its oncology drug pipeline, Qualigen has an established diagnostic business that manufactures and distributes proprietary and highly accurate rapid blood test systems for the management of prostate cancer and other diseases and health conditions. Qualigen’s management has significant experience in the development, manufacture, marketing and distribution of drugs and medical devices.

For more information about Qualigen Therapeutics, Inc., please visit www.qualigeninc.com.

Looking to the future Statements

This press release contains forward-looking statements of the Company which involve risks and uncertainties and reflect the judgment of the Company as of the date of this press release. These statements include those relating to the Company’s outlook and strategy for the development of therapeutic drug candidates. Actual events or results may differ from the Company’s expectations. For example, there can be no assurance that the Company will develop drugs (including QN-247 and RAS-F); that the preclinical or clinical development of the Company’s drugs (including QN-247 and RAS-F, and priority infectious disease programs such as QN-165) will be completed according to any planned schedule or will be crowned of success ; that any clinical trial will be approved to commence or proceed as planned by any projected timeline; that the data from future clinical trials will be favorable or that these trials will confirm any improvement over other products or have no negative impact; that all drugs will receive the required regulatory approvals (including orphan drug status) or become commercially successful; that patents will be issued on patent applications owned and licensed by the Company; that these patents, if any, and the patents currently owned and licensed by the Company would prevent competition; that the Company will be able to acquire or earn sufficient working capital to complete the development, testing and launch of the Company’s potential therapeutic products (including QN-247 and RAS-F, and any repositioning of QN -165); or that the Company will be able to maintain or expand market demand and / or market share for the Company’s diagnostic products. The price of the Company’s shares could be affected if any of the events or trends contemplated by the forward-looking statements do not occur or are delayed or if an actual future event otherwise differs from expectations. Additional information regarding these and other risk factors affecting the Company’s business can be found in the Company’s previous documents with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available on www.sec.gov.

The Company disclaims any intention or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This warning is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations:

For more information: David Kugelman
Atlanta Capital Partners, LLC
(404) 856-9157 or (866) 692-6847 Toll free – United States and Canada
[email protected]

Tony schor
Investor Awareness, Inc.
(847) 971-0922
[email protected]


1 Di Cerbo, A .; Quagliano, N .; Napolitano, A .; Pezzuto, F .; Iannitti, T .; Di Cerbo, A. Comparison between an emerging point-of-care tool for TSH assessment and a centralized laboratory method in a cohort of patients from southern Italy. Diagnostic 2021, 11, 1590. https://doi.org/10.3390/diagnostics11091590.

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