GenoPredicta
GenoPredicta for Blood or Bone Marrow
For Physicians
What is the GenoPredicta test and why should I order it for my patient?
GenoPredicta employs whole genome sequencing (WGS) to detect genomic alterations in tumor cells obtained from either the bone marrow or circulating tumor cells from peripheral blood of Multiple Myeloma (MM) patients or related plasma cell dyscrasias, such as Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Myeloma and Amyloidosis or other related disorders.
The intended use of the GenoPredicta test is to provide ordering physicians with a molecular diagnostic tool to measure a spectrum of genomic alterations to diagnose individuals at a molecular level to determine prognostic risk of MM (high-risk MM) and inform therapeutic management.
The current diagnosis of MM (and other hematological malignancies) requires a bone marrow biopsy and testing of tumor cells for major genetic alterations by fluorescence in situ hybridization (FISH), which is unable to detect some key molecular hallmarks and drivers of MM.
The GenoPredicta test aims to overcome the many limitations in the current standard of care of myeloma diagnosis and prognosis.
FISH does not detect single nucleotide variants (SNVs) or small insertions/deletions (InDels) that are critical for the prognosis of myeloma such as mutations in TP53, KRAS, etc. This is also critical to identify specific alterations that are core to determining response/resistance to therapy such as BCMA deletion or GPRC5D mutations that are predictive of response/resistance to immunotherapies targeting BCMA and GPRC5D on the surface of MM cells.
Does GenoPredicta satisfy the new International Myeloma Society and International Myeloma Working group (IMS/IMWG) guidelines?
Yes, it satisfies the requirements set by the IMS/IMWG guidelines that mandate the use of next generation sequencing to identify patients with high-risk MM (JCO, 2025).
The reported somatic variants include prognostic cytogenetic variants that are currently tested in common practice using FISH assays, as well as other clinically relevant genetic alterations in MM, including:
- Structural variants (SV) – Genomic translocation events including IGH translocations such as IGH::CCND1 t(11;14), IGH::FGFR3/NSD2 t(4;14), IGH::MAF t(14;16), and IGH::MAFB t(14;20).
- Copy number variants (CNV) – Large chromosomal gains/losses such as Del1p (CDKN2C loss/deletion), 1q+ (CKS1B gain/amplification) and Del17p (TP53 loss/deletion), as well as small focal events, such as TP53 deletions.
- It also identifies mutations/alterations in TP53 and biallelic deletion of 1p32, which are part of the IMS/IMWG guideline requirements but cannot be detected by FISH.
Does GenoPredicta identify resistance mechanisms to BMCA or GPRC5D targeted therapies?
Yes, one of the mechanisms of resistance to BMCA or GRPRC5D therapies (such as CAR-T or bispecific antibodies) is deletions or mutations in the target genes (Lee et al, Nature Medicine, 2023). In fact, recent studies indicate that up to 51% of patients in the relapsed/refractory setting may have these deletions and may not respond to those immunotherapies (Lee, ASH Abstract 4651, 2024).
GenoPredicta for bone marrow or blood is a WGS-based assay and therefore can identify SNVs and short insertion/deletion (InDel) variants in therapeutic targets, including TNFRSF17 (BMCA) and GPRC5D.
However, GenoPredicta currently does not detect other resistance mechanisms, including downregulation of TNFRSF17/GPRC5D or epigenetic silencing of GPRC5D.
Can GenoPredicta replace a bone marrow biopsy?
Yes – while the initial diagnosis of MM still requires a bone marrow biopsy, follow-up monitoring may not necessitate this in the future. FISH and other next generation sequencing (NGS) tests available to date always require a bone marrow biopsy for the collection of malignant plasma cells, which is an intrusive and painful procedure, and limits monitoring patients throughout their health care journey. GenoPredicta can overcome this challenge and improve prognostication in patients without the need of a bone marrow biopsy by using a minimal number (~50 cells) of circulating tumor cells from peripheral blood.
GenoPredicta on bone marrow and peripheral blood shows 100% concordance across all clonal alterations.
What is the difference between GenoPredicta for blood or bone marrow and how does it compare to FISH?
GenoPredicta is a cutting-edge test that can replace painful bone marrow biopsies and outdated FISH. The table shows a head-to-head comparison of GenoPredicta with FISH. Please note that GenoPredicta MRD+ is expected to be available at the end of 2025 and is not currently available. In the future, GenoPredicta will also be available for other hematological malignancies.
How do I interpret the clinical report?
What is the workflow and when should I expect results back?
For Patients
The right test for the right treatment
GenoPredicta - a more accurate and sensitive way to test myeloma genetics in both the bone marrow and blood
What are the problems with diagnosing and monitoring multiple myeloma?
Diagnosing multiple myeloma (MM) and similar blood cancers today means getting a bone marrow biopsy, which is often a painful and uncomfortable procedure. Doctors then run a test using a technology called FISH to look for mutations in your cancer cells’ DNA. But this test doesn't always work well, and in some cases, it can miss important changes in your genes. These changes can help predict how aggressive your myeloma is and guide your treatment. For example, how you might respond to newer immune-based therapies like CAR-T therapy or bispecific antibodies, or if certain treatments might not work as well for you.
What is the GenoPredicta test?
The GenoPredicta test can use either bone marrow or a blood sample, and is a more accurate, sensitive way of profiling your myeloma — helping doctors better understand your disease and how it might respond to different treatments. GenoPredicta uses a powerful method called whole genome sequencing to look closely at the DNA of cancer cells. When your doctor orders a bone marrow biopsy, this can provide more accurate and sensitive information than FISH.
With an advanced test like GenoPredicta, your care team may be able to make more personalized and effective treatment decisions — right from the start. For example, it can find changes in your genes that might stop certain treatments, like CAR-T therapy, from working properly.
GenoPredicta is designed to improve how we understand and manage multiple myeloma — helping doctors make more accurate predictions and choose better treatments for you.
Can a blood sample replace a bone marrow biopsy?
While a bone marrow biopsy is needed to diagnose multiple myeloma initially, follow-up testing with GenoPredicta can often be done using just a simple blood sample. This test can provide the same—or sometimes even more—information than a bone marrow biopsy, and in many cases, it can eliminate the need for another biopsy when your doctor chooses not to perform one.
Who can get GenoPredicta?
Patients who have detectable disease in the bone marrow or blood are eligible for GenoPredicta. If you are in deep remission, you may not have enough cells for us to measure them with the current GenoPredicta test, but a version of GenoPredicta designed for this purpose is expected to be available at the end of 2025.
Ask your doctor to order the GenoPredicta test.
Your provider will order theGenoPredicta test from either a bone marrow or blood sample.
Predicta Biosciences will receive your sample, run the test, and send the test results back to your doctor as a clinical report.
Your doctor will share the genetic information with you and how it changes your therapy or your prognosis.
Your doctor can repeat this test as many times as needed to monitor your care.
Consent to Testing
Your doctor will provide you with the document included here. Please read it carefully.
How much does it cost?
Predicta Biosciences is committed to provide care to every patient regardless of insurance coverage. You may also opt to pay for the test directly. We will work with your provider and insurance for the coverage of this test.
Self-pay option
For international patients and uninsured patients, we offer a self-pay option. Please provide your information to your provider to include on the requisition form.
Questions
You can contact us at genopredicta@predictabiosciences.com for any questions.
Order GenoPredicta
How do I order the test?
You can download the TRF and the patient consent form, and you can email us the signed form.
You can also fill out the TRF electronically using DocuSign.
Please make sure it is also printed and shipped with the specimen before shipping. Please see shipping instructions here.
You can email it to us at genopredicta@predictabiosciences.com
What if I have other questions?
Please do not hesitate to contact us at genopredicta@predictabiosciences.com or call us for any urgent request at +1-781-691-3159.