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Genosity Inks Deal With Gemini Therapeutics to Develop Assay for AMD Clinical Trial Patient Selection

NEW YORK — Genosity said on Wednesday that it has signed an agreement to develop a molecular diagnostic for use in selecting patients for a clinical trial of a dry age-related macular degeneration (AMD) drug candidate under development by Gemini Therapeutics.

Gemini's drug, called GEM103, is designed for dry AMD in patients with disease-associated complement factor H (CFH) loss-of-function gene variants.

Under the terms of its agreement with Gemini, Genosity will use samples from prospective clinical study participants to create a custom next-generation sequencing panel that can identify individuals with these CFH variants. Genosity will then validate the assay and use it to help Gemini select patients suitable for enrollment in a Phase IIa study of GEM103.

Additional terms were not disclosed.

"Gemini is a leader in leveraging molecular information to develop precision therapeutics in AMD and we are excited to expand our testing menu to support another partner's need to have a unique biomarker test available for trial support," Genosity Cofounder and President Robert Daber said in a statement.

In early 2020, Genosity partnered with Columbia University to sequence samples of patients with wild-type cardiac amyloidosis to identify potential disease-causing genes and pathways. In August, the Iselin, New Jersey-based company received CLIA approval for a liquid biopsy assay for cancer monitoring and residual disease detection in biopharmaceutical research and clinical trials.