Predicta Biosciences Unveils First Molecular Diagnostic for Enhancing Multiple Myeloma Prognosis
Predicta Biosciences, a precision oncology company, has officially launched its first Laboratory Developed Test (LDT), GenoPredicta, a cutting-edge diagnostic tool designed for use in both blood and bone marrow samples. The test, which leverages advanced genomic and immune profiling, offers significant promise in the early detection, diagnosis, and treatment planning for multiple myeloma, a type of blood cancer that remains one of the most challenging diseases to manage in oncology today. The test is conducted in a CLIA-approved laboratory, ensuring the highest standards of quality and accuracy in molecular diagnostics.
Revolutionizing Blood Cancer Diagnostics and Therapeutics
The introduction of GenoPredicta marks a pivotal moment in the world of precision oncology. Multiple myeloma, a blood cancer that affects plasma cells, remains one of the most complex hematological malignancies to diagnose and treat, primarily because of the limited availability of reliable, sensitive testing methods. The disease is the second most common form of blood cancer after lymphoma, and despite advancements in treatment, a cure remains elusive for the majority of patients.
The traditional methods of diagnosing blood cancers, including bone marrow biopsies and fluorescence in situ hybridization (FISH) tests, present significant challenges. Bone marrow biopsies are invasive, painful, and often difficult for patients, while FISH tests can be inaccurate and lack reproducibility across laboratories. Moreover, these techniques fail to detect some of the key molecular hallmarks of multiple myeloma, leaving a critical gap in the ability to tailor therapies effectively for individual patients.
To address these challenges, Predicta Biosciences has developed GenoPredicta, a test that can detect a spectrum of genomic alterations through whole genome sequencing (WGS) of bone marrow or blood samples. The test not only enables a more accurate diagnosis of multiple myeloma but also provides clinicians with valuable insights into the prognosis of the disease and the likelihood that a patient will respond to specific therapies.
Precision Diagnosis for Better Outcomes
GenoPredicta is poised to transform the landscape of multiple myeloma diagnosis by enabling earlier and more accurate detection of genetic alterations that are crucial for effective treatment planning. By identifying high-risk genomic profiles in patients, GenoPredicta supports clinicians in making more informed decisions about how to approach treatment and prognosis.
Dr. Irene Ghobrial, MD, co-founder of Predicta Biosciences, emphasizes the significant impact that the test will have on both diagnosis and treatment: “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. 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.”
Key Features and Capabilities of GenoPredicta
GenoPredicta is more than just a diagnostic tool; it is an advanced platform that uses WGS to detect a wide range of genomic alterations in tumor cells obtained from either bone marrow or peripheral blood. This capability is vital for patients with multiple myeloma, as it helps identify mutations and genetic variations that influence both the progression of the disease and the patient’s response to therapies.
One of the most groundbreaking aspects of GenoPredicta is its ability to identify patients with high-risk multiple myeloma, meeting the criteria outlined by the International Myeloma Society and International Myeloma Working Group. The test also plays a crucial role in stratifying patients based on their risk of disease progression, which is essential for providing the right treatment at the right time.
In addition, GenoPredicta can detect specific mutations in the BCMA gene (B-cell maturation antigen) and GPRC5D, which are critical to understanding why certain patients may not respond to therapies like CAR-T (chimeric antigen receptor T-cell therapy) and bispecific antibodies. By identifying these mutations early, clinicians can avoid ineffective treatments and instead focus on alternative, more targeted therapeutic options.
Unlike traditional FISH tests, which are limited in their ability to detect key genomic markers, GenoPredicta provides a comprehensive, accurate view of the patient’s genetic profile. The test can identify additional genomic variants that may be relevant for targeted therapies and immunotherapies, enabling a more precise and personalized approach to care.
A Multi-Omic Approach for Future Therapies
Predicta Biosciences is not stopping with GenoPredicta. The company is building a broader, transformative diagnostic and analytics platform aimed at revolutionizing the way blood cancers and autoimmune diseases are diagnosed and treated. This platform integrates deep genomic and immune profiling, unlocking a wealth of information that can help clinicians understand the complex biology of these diseases and make more informed treatment decisions.
GenoPredicta has already been utilized in research at the prestigious Dana-Farber Cancer Institute, where it has been employed for prognosis, risk stratification, and the identification of patient responses or resistance to specific therapies, including BCMA-targeting bispecific antibodies and CAR-T therapy in multiple myeloma patients. The Biosciences research results highlight the potential of GenoPredicta to guide clinical decision-making, not only in early diagnosis but also in the selection of the most appropriate treatments for patients.
In addition to its diagnostic capabilities, GenoPredicta is expected to play an essential role in monitoring minimal residual disease (MRD), a critical aspect of multiple myeloma management. MRD monitoring allows Biosciences clinicians to track the presence of residual tumor cells following treatment and assess the risk of relapse. The MRD version Biosciences of GenoPredicta is expected to be available for order later this year, providing even greater precision in monitoring disease progression.
The Path Ahead for Predicta Biosciences
The launch of GenoPredicta follows a successful seed funding round in July 2024, led by Engine Ventures, which enabled Predicta Biosciences to advance its mission to develop precision diagnostic products that address significant unmet Biosciences needs in oncology and autoimmune disease care. With the release of GenoPredicta, the company is poised to make a substantial impact in the field of blood cancer diagnostics, and it is already looking ahead to its next major innovation.
In 2026, Predicta plans to launch ImmunoPredicta, a second platform product that will offer a comprehensive characterization of the immune system in multiple myeloma patients. This new tool will complement GenoPredicta by providing additional insights into how the patient’s immune system interacts with their cancer, helping to further refine treatment strategies.
Predicta’s long-term vision includes expanding its diagnostic portfolio beyond multiple myeloma to address other common blood cancers and autoimmune diseases. By continuing to leverage cutting-edge genomic and immune profiling technologies, the company aims to offer a suite of precision diagnostic tools that will empower clinicians to provide better, more targeted care for patients suffering from a wide range of complex diseases.
The launch of GenoPredicta by Predicta Biosciences represents a significant step forward in the field of precision oncology. By providing clinicians Biosciences with a powerful, accurate, and non-invasive tool for diagnosing and managing multiple myeloma, GenoPredicta promises to improve patient outcomes, reduce reliance on invasive procedures, and open the door to more personalized treatment strategies. As the company continues to expand its platform and develop additional diagnostic products, Predicta is poised to play a leading role in transforming the landscape of cancer care and beyond.
