TEST:

OncoPrism™ Assay

P=N/A, N=0, Withdrawn, Cofactor Genomics, Inc. | N=40 --> 0 | Trial completion date: Apr 2024 --> Feb 2025 | Recruiting --> Withdrawn | Trial primary completion date: Apr 2024 --> Feb 2025

Robust and reliable analytical performance of the OncoPrism-HNSCC assay supports its clinical use, even in the presence of variation typically encountered in the laboratory setting.

P; Here, we demonstrate the clinical validity of the OncoPrism-HNSCC assay in identifying patients with disease control in response to anti-PD-1 immune checkpoint inhibitors.

"Cofactor Genomics, Inc...announced today that Medicare contractor Palmetto GBA has granted national coverage for OncoPrism. OncoPrism is a solid tumor predictive diagnostic test that evaluates a patient's tumor immune profile against Cofactor’s high-dimensional RNA-based Health Expression Models (HEMs) to predict a patient’s response to immune checkpoint inhibitor (ICI) immunotherapy. The Medicare coverage decision is for recurrent and metastatic head and neck squamous cell carcinoma (RM-HNSCC) patients being considered for ICI immunotherapy treatment as a single agent or in combination with chemotherapy."

P=N/A; Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Jul 2023 --> Apr 2024

"Cofactor Genomics...announced successful validation of the OncoPrism immunotherapy predictive diagnostic assay, enabling physicians to use the test to help guide treatment decisions for patients with metastatic or recurrent squamous cell carcinoma of the head and neck (HNSCC)."

"Culmination Bio...and Cofactor Genomics...announced a partnership to leverage samples and data from one of the largest biobanks in the country to fuel the development of Cofactor Genomic’s OncoPrism™ test in 11 cancers."

P=N/A; N=85 --> 40

P=N/A; Trial completion date: Jul 2023 --> Dec 2023

"Cofactor Genomics...today announced commencement of a study of its OncoPrism™ assay in non-small cell lung cancer (NSCLC), the second indication being studied in the company’s national PREDAPT study that will ultimately encompass 11 cancers....'We intend to grow our clinical and biomarker team quickly to expedite validation of our lung cancer assay so it will closely follow our head and neck cancer assay in 2023'."

P=N/A; Trial completion date: Feb 2023 --> Feb 2027 | Trial primary completion date: Feb 2023 --> Feb 2027

"Cofactor Genomics' OncoPrism platform, which combines immune cell quantification and T-cell subtyping, has outperformed PD-L1 testing as a method to identify cancer patients who will respond to immunotherapy...The San Francisco-based company's platform has shown in the PREDAPT trial that it was twice as accurate in identifying which patients would respond to immunotherapy compared to PD-L1 by immunohistochemistry. At a scientific meeting earlier this month, Cofactor reported data from the trial evaluating OncoPrism against standard PD-L1 IHC testing in patients with head and neck cancer, non-small cell lung cancer, and melanoma."

"Data show that Cofactor's OncoPrism test using Predictive Immune Modeling was nearly twice as accurate as PD-L1 assays in determining patients that will benefit from immunotherapies such as Keytruda (pembrolizumab)....In clinical studies where OncoPrism was tuned to have the same sensitivity as PD-L1, Cofactor’s test reached 75% accuracy in predicting responders to immune checkpoint inhibitors, when compared to 42% accuracy for PD-L1. These interim results from nine healthcare systems show at similar sensitivity, OncoPrism has greater specificity and continues to be superior to single analyte approaches like PD-L1....The study results provide a strong framework and understanding for the other important cancers we will be studying in our broader PREDAPT work, including non-small cell lung cancer (NSCLC)."

P=N/A; Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: May 2022 --> May 2023

P=N/A; N=85; Recruiting; Sponsor:Cofactor Genomics, Inc.

P=N/A; Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Feb 2023

P=N/A; Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Feb 2021 --> Feb 2022

P; N=1650; Recruiting; Sponsor: Cofactor Genomics, Inc.