GenoPredicta Marrow and GenoPredicta Blood are LDT approved, leverage leading edge genomic profiling to diagnose and guide therapeutic interventions

CAMBRIDGE, Mass.: Predicta Biosciences, a precision oncology company developing novel diagnostic and therapeutic products, today announced the availability of its first Laboratory Developed Test (LDT): GenoPredicta for bone marrow or blood. The test measures a spectrum of genomic alterations and can be used by ordering physicians to molecularly diagnose individuals who have or are at risk for multiple myeloma and inform therapeutic management. The test is conducted in a CLIA-approved laboratory.

Leveraging deep genomic and immune profiling, Predicta is building a transformative, multi-omic diagnostic and analytics platform to unlock precision therapeutics. The company’s initial focus is on developing diagnostic solutions for blood cancers and autoimmune diseases to address a large unmet need in the current standard of care. Currently, blood cancers with no cure, including multiple myeloma, which is the second most common blood cancer after lymphoma, still lack accurate, sensitive testing options for early detection. Predicta has set out to solve this challenge with both bone marrow and blood tests that can help doctors better understand and predict patients’ conditions, and how they might respond to different treatments.

“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 Irene Ghobrial, MD, co-founder of Predicta. “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.”

Predicta’s diagnostic platform includes GenoPredicta, which has been used in a research capacity at the Dana-Farber Cancer Institute for prognosis, risk stratification and identification of response or resistance to specific therapies, including BCMA-targeting bispecific antibodies and CAR-T therapy in multiple myeloma. GenoPredicta is now an LDT test for bone marrow and blood specimens and employs whole genome sequencing (WGS) to:

• Identify patients with high-risk multiple myeloma, satisfying the requirements of the International Myeloma Society and International Myeloma Working Group.
• Reveal patients who won’t respond to certain therapeutic agents such as CAR-T and bispecific antibodies, by identifying mutations in BCMA and GPRC5D.
• Detect genomic alterations in tumor cells obtained from either the bone marrow or peripheral blood (circulating tumor cells) of multiple myeloma patients.
• Diminish the reliance on FISH and comparable diagnostic tools, offering equivalent results whether derived from a bone marrow biopsy or simple blood-based test.

The GenoPredicta test evaluates for prognostic cytogenetic variants that are commonly tested for using FISH assays. As a WGS-based assay, the GenoPredicta test can also be used to identify additional variant types that are not currently tested for, which can be relevant for targeted therapy and immunotherapy selection. GenoPredicta for Minimal Residual Disease (MRD) monitoring is expected to become available for order later this year.

The launch of GenoPredicta follows the company’s July 2024 seed funding round, led by Engine Ventures. In 2026, the Company will launch the second platform product, ImmunoPredicta, which characterizes the immune system for multiple myeloma patients. The company plans to expand beyond multiple myeloma, offering precision diagnostic products for other common blood cancers and autoimmune diseases.

About Predicta Biosciences

Founded by leading cancer genomics researchers and clinicians, Predicta is a precision oncology company developing novel diagnostic and therapeutic products. The company’s non-invasive diagnostics initially focus on multiple myeloma, equipping physicians with the unique ability to determine the likelihood of a patient responding to immunotherapies. Leveraging extensive genomic and immune profiling patient data, Predicta is also building a one-of-a-kind clinical database for identifying new therapeutic targets. The company is backed by Engine Ventures, Illumina Ventures, the American Cancer Society’s Bright Edge and Time Boost Capital among others. For more information, visit www.predictabiosciences.com

Fonte: Business Wire