Golden, Colorado — January 26, 2023 — Theralink Technologies (OTC: THER) (“Theralink” or the “Company”), a precision oncology company with a novel quantitative protein and phosphoprotein-based assay for breast cancer, today announced that the Company has received its Clinical Laboratory Permit from the New York State Department of Health for its Golden, Colorado Laboratory, effective December 22nd, 2022.
The Clinical Laboratory Improvements Act (CLIA) Program is put in place by the Centers for Medicare & Medicaid Services (CMS) to regulate laboratories that test human specimens. The results of the New York State Laboratory Permit allow Theralink to accept and perform testing on human specimens from New York. The New York Department of Health survey showed that all CLIA condition-level requirements were met, adhering to the highest standards in the industry.
Faith Zaslavsky, President & Chief Operating Officer of Theralink said, “The New York state clinical laboratory permit is a significant milestone in our overall plan to assist oncologists with customized patient treatment selection based upon our predictive biomarker test. We look forward to partnering with the clinical community on the mission of improving cancer care and outcomes for the people of New York state.”
Ms. Zaslavsky went on to say, “We are already in discussions with numerous New York state cancer programs, and we look forward to helping them achieve their patient care and financial objectives for their precision oncology programs. In addition, the New York state cancer care market represents one of largest opportunities for Theralink as it relates to helping women living with breast cancer.”
Theralink has now achieved national CLIA-certification and CAP-accredited regulatory status for its corporate initiatives. We are now receiving, testing, and billing for patient’s breast cancer tumor specimens across the US.
About Theralink Technologies, Inc.
Theralink Technologies is a proteomics-based, precision medicine company with a CLIA-certified and CAP-accredited laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink’s technology targets multiple areas of oncology and drug development. In addition to the Company’s first assay for advanced breast cancer, Theralink is actively working on a second assay that is planned to be pan-tumor for solid tumors across multiple tumor types such as ovarian, endometrial, pancreatic, liver, head and neck, colorectal, lung, prostate, among others. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, help reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit www.theralink.com.
Valter Pinto, Managing Director
KCSA Strategic Communications
Certain statements contained in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, anything relating or referring to future financial results, patient enrollment and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by Theralink Technologies with the Securities and Exchange Commission. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business and although the company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements contained herein. The company undertakes no obligation to publicly release statements made to reflect events or circumstances after the date hereof.