CAMBRIDGE, Mass. — Predicta Biosciences, a precision oncology company, has launched its first molecular diagnostic product aimed at transforming the diagnosis and treatment management of multiple myeloma, the second most common blood cancer. The test, known as GenoPredicta, is now available as a Laboratory Developed Test (LDT) for both bone marrow and blood samples, and is processed in a CLIA-approved laboratory.
GenoPredicta is designed to detect a wide range of genomic alterations that can help physicians diagnose patients who have or are at risk for multiple myeloma, as well as guide decisions around therapeutic strategies. By leveraging whole genome sequencing, the test provides a more comprehensive and accurate alternative to conventional diagnostics such as bone marrow biopsies and fluorescence in situ hybridization (FISH), which have long been criticized for their invasiveness, variability, and limited sensitivity.
“Historically, diagnosing hematological malignancies has required intrusive bone marrow biopsies and reliance on FISH, which lacks the ability to detect key molecular features of these cancers,” said Dr. Irene Ghobrial, co-founder of Predicta. “Our new GenoPredicta test addresses these limitations, enabling more precise diagnosis and prognosis for multiple myeloma and other blood cancers, while helping physicians select the most effective treatment pathways.”
The GenoPredicta platform has already been utilized in research settings at Dana-Farber Cancer Institute for risk stratification and identifying resistance or responsiveness to therapies such as CAR-T and BCMA-targeting bispecific antibodies. Now available for clinical use, the test can identify high-risk multiple myeloma cases as defined by the International Myeloma Society, and detect mutations that may indicate resistance to specific immunotherapies, including those targeting BCMA and GPRC5D.
One of the key advancements offered by GenoPredicta is its ability to analyze tumor DNA from either bone marrow samples or circulating tumor cells in the blood. This flexibility reduces the need for invasive biopsies, while maintaining diagnostic precision. The test also surpasses traditional FISH-based assays by identifying additional genetic variants relevant to targeted therapies and immunotherapy selection.
Predicta plans to expand its diagnostic capabilities with the launch of GenoPredicta for minimal residual disease (MRD) monitoring later this year. This will allow for more refined assessments of treatment response and disease recurrence in multiple myeloma patients.
The product launch follows Predicta’s seed funding round in July 2024, led by Engine Ventures. The company’s next offering, ImmunoPredicta, is expected in 2026 and will focus on immune system characterization for multiple myeloma. Looking ahead, Predicta aims to broaden its platform to serve other blood cancers and autoimmune diseases, addressing persistent diagnostic gaps across a wider range of conditions.
