TEST:

Theralink Assay

"Theralink Technologies...announced that their long-standing, strategic partnership with the Inova Schar Cancer Institute (Inova) is beginning to deliver promising results by way of assessing the feasibility and impact of the actionable information provided by the Theralink assay into Inova’s Molecular Tumor Board (MTB)-based treatment decisioning making for cancer patients."

Our data suggest that quantification of key cancer proteins and phosphoproteins using RPPA extend the identification of actionable drug targets beyond what was found with WES/WTS testing alone. Especially the quantification of total and phospho-HER2 identified a significant pan-tumor subpopulation that may benefit from HER2-targeted therapies, including trastuzumab deruxtecan (T-Dxd).

"Theralink Technologies...announced the acceptance of two poster presentations evaluating the potential use and utility of its novel RPPA (Reverse Phase Protein Array) technology at the San Antonio Breast Cancer Symposium (SABCS) 2022."

"Theralink Technologies...announced that the Company has received the final price determination for Medicare reimbursement, has completed the Medicare enrollment process and received its Provider Transaction Access Number (PTAN)."

Our study suggests the TLA yields useful information for selecting treatment for breast cancer patients with advanced/recurrent disease. In this prospective analysis, the assay identified actionable targets in more than 90% of patients, which is significantly higher than what has previously been reported for genomic profiling alone. Overall, physicians found the information yielded by the assay useful for selecting treatment.

"Theralink Technologies...announced that it has acquired licenses for two new U.S. patents relating to methods for treating breast cancer: US 10,823,738 and US 10,690,672, expanding the Company's patent portfolio to nine. Theralink has licensed the patents from George Mason University, strengthening and extending the current Theralink IP family that covers specific 'predictive' biomarkers....'Significantly, physicians can now order the Theralink Assay for Breast Cancer and use it to expand the use of PARP inhibitors and HER2-EGFR inhibitors to breast cancer patients'..."

"Theralink Technologies...today announced that it has significantly expanded the adoption of its Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA) precision medicine technology to biopharmaceutical companies, including multinational healthcare corporations. The Company has supported 41 preclinical and clinical studies for 18 biopharma companies and is currently undergoing discussions to develop Companion Diagnostics (CDx) with several of its existing clients."

"Avera Health (Avera)...and Theralink Technologies...today announced a strategic collaboration to advance comprehensive molecular profiling, enabling Avera Health's providers and patients to benefit from data-driven insights that inform targeted cancer treatments....Theralink will provide key patient-specific information about which drug targets are activated and 'in use' in each patient tumor sample. This information, coupled with the genomics findings, will provide a comprehensive molecular profile for all Avera oncology patients by way of a multiomic report used for physician treatment decisions."

"Theralink Technologies...announced that the American Medical Association (AMA) has recently issued a new, dedicated Proprietary Laboratory Analyses (PLA) code for the Theralink Assay for Advanced Breast Cancer. The Theralink assay measures the tumor cell levels of activated proteins, which are the primary targets of most FDA-approved therapies and biopharmaceutical investigational drugs. The new PLA code is 0249U. In addition, Theralink has submitted information to the appropriate Medicare Administrative Contractors (MAC’s) that will help them in establishing an appropriate rate for the Theralink test."

"Theralink Technologies...today announced early results showing actionability and clinical utility for its commercial CLIA assay. Actionability is defined as providing physicians with test results that are actionable for patient treatment selection and Clinical Utility is defined as the percentage of times that the physician acts upon those test results to select next course of treatment for the patient...Theralink assay results were analyzed from an initial cohort of 118 patients with advanced breast cancer whose oncologists ordered the Theralink assay for treatment planning. Biomarker treatment implications were summarized for potential therapy options that are commonly listed on the Theralink Report which also factors into each patient’s prior treatment history and ER/PR/HER2 status. Actionable insights from this novel phosphoprotein panel assay span a wide range of therapy options. Overall actionability rate was greater than 90% in each breast cancer subtype."