Predicta Biosciences announced today the commercial launch of GenoPredicta, its first Laboratory Developed Test (LDT) designed to improve diagnosis and treatment decisions for multiple myeloma patients. The test, available for both bone marrow and blood samples, employs whole genome sequencing (WGS) to measure genomic alterations in patients with or at risk for multiple myeloma.
The Cambridge, Massachusetts-based precision oncology company developed GenoPredicta to address significant limitations in current diagnostic approaches for blood cancers. The test is conducted in a CLIA-approved laboratory and provides physicians with molecular diagnostic information to guide therapeutic management.
"Historically, diagnosing hematological malignancies has required bone marrow biopsies, which are intrusive and painful for patients, and fluorescence in situ hybridization (FISH) tests, which lack accuracy and reproducibility across labs, and are unable to detect some of the key molecular hallmarks of these types of cancers," said Dr. Irene Ghobrial, co-founder of Predicta Biosciences.
Advancing Multiple Myeloma Diagnostics
Multiple myeloma, the second most common blood cancer after lymphoma, has traditionally lacked accurate and sensitive testing options for early detection. GenoPredicta aims to transform this landscape by offering both bone marrow and blood-based testing that can help clinicians better understand patient conditions and predict treatment responses.
The test satisfies requirements established by the International Myeloma Society and International Myeloma Working Group for identifying high-risk multiple myeloma patients. It can also reveal patients unlikely to respond to certain therapeutic agents, including CAR-T and bispecific antibodies, by identifying mutations in targets such as BCMA and GPRC5D.
Importantly, GenoPredicta can detect genomic alterations in tumor cells from either bone marrow or peripheral blood (circulating tumor cells), potentially reducing reliance on invasive bone marrow biopsies while delivering equivalent diagnostic results.
Clinical Applications and Development History
Prior to its commercial launch, GenoPredicta was used in a research capacity at the Dana-Farber Cancer Institute for prognosis, risk stratification, and identification of response or resistance to specific therapies in multiple myeloma patients.
As a WGS-based assay, GenoPredicta evaluates prognostic cytogenetic variants typically tested with FISH assays while also identifying additional variant types relevant for targeted therapy and immunotherapy selection.
The company plans to expand its diagnostic offerings later this year with GenoPredicta for Minimal Residual Disease (MRD) monitoring, an important tool for tracking treatment effectiveness and disease recurrence.
Building a Comprehensive Diagnostic Platform
Predicta Biosciences is leveraging deep genomic and immune profiling to build a transformative, multi-omic diagnostic and analytics platform aimed at unlocking precision therapeutics. The company's initial focus on blood cancers and autoimmune diseases addresses significant unmet needs in current standards of care.
"Our new GenoPredicta test aims to overcome the many limitations in the diagnosis and prognosis of multiple myeloma, plasma cell malignancies and other blood cancers, and ultimately optimize treatment decisions for patients throughout their disease journey," Dr. Ghobrial explained.
The launch follows Predicta's July 2024 seed funding round led by Engine Ventures. The company has outlined plans to launch its second platform product, ImmunoPredicta, in 2026. This test will characterize the immune system for multiple myeloma patients. Predicta also intends to expand beyond multiple myeloma to offer precision diagnostic products for other common blood cancers and autoimmune diseases.
Predicta Biosciences is backed by Engine Ventures, Illumina Ventures, the American Cancer Society's Bright Edge, and Time Boost Capital, among other investors.
