GenoPredicta™

A cutting-edge genomic test for myeloma from blood or marrow

For physicians ↓
For patients ↓
For physicians

GenoPredicta™ provides ordering physicians with a molecular diagnostic tool to measure a spectrum of genomic alterations to determine prognostic risk of multiple myeloma (and other hematological malignancies) and inform therapeutic management.

The current diagnosis of MM requires a bone marrow biopsy and testing of tumor cells for major genetic alterations by fluorescence in situ hybridization (FISH), which requires a large disease burden and is unable to detect some key molecular hallmarks and drivers of MM.

GenoPredicta™ 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.

GenoPredicta™'s comprehensive characterization 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.

What is the GenoPredicta™ test?
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.
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GenoPredicta™ is a cutting-edge test that can replace painful bone marrow biopsies and outdated FISH.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. In the future, GenoPredicta™ will also be available for other hematological malignancies.
FISH Marrow Blood
Fresh or frozen samples ✓ ✓ ✓
Minimally invasive ✗ ✗ ✓
Cell requirements 50/probe ~50 ~50
All genetic alterations* from WGS ✗ ✗ ✓
Satisfies new IMS high-risk criteria (TP53 sequencing) ✗ ✓ ✓
Detects mutations/deletions of therapeutic targets ✗ ✓ ✓
Discovers new resistance markers ✗ ✓ ✓
Representative of all lesions/clones, not just sampled site ✗ ✗ ✓
Monitoring of treatment response (clonal evolution) ✗ ✗ ✓
Other blood cancers ✗ ✗ ✓
All disease states ✗ ✗ ✗
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
Bone Marrow
Peripheral Blood
Does GenoPredicta™ identify resistance mechanisms to BCMA or GPRC5D targeted therapies?
Yes, one of the mechanisms of resistance to BCMA 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 (BCMA) and GPRC5D.
  • However, GenoPredicta™ currently does not detect other resistance mechanisms, including downregulation of TNFRSF17/GPRC5D or epigenetic silencing of GPRC5D.
Does GenoPredicta™ satisfy the new IMS/IMWG guidelines?

Yes, it satisfies the requirements set by the International Myeloma Society/International Myeloma Working Group (IMS/IMWG) guidelines that mandate the use of next generation sequencing to identify patients with high-risk MM (Avet-Loiseau et al., Journal of Clinical Oncolology, 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.
2025 IMS Consensus Staging of High Risk Multiple Myeloma
  • Del(17p) and/or TP53 mutation*
  • t(4;14) or t(14;16) or t(14;20) and 1q+ and/or del(1p32)
  • Monoallelic del(1p32) and 1q+, or biallelic del(1p32)*

*WGS required

What does the GenoPredicta™ clinical report look like?
Our end-to-end pipeline automatically generates a clinical report from raw genomic sequencing data.
Frequently asked questions
  • What type of sample is required?
    We can use either a blood sample or bone marrow. For fresh peripheral blood, the volume is ideally up to 30 ml, with a minimum of 10 ml volume required. The minimum requirement for fresh bone marrow aspirate is 2 ml in one EDTA tube.
  • How do I order a test?
    • Complete the GenoPredicta™ Test Requisition Form (TRF).
    • Samples must be sent to Predicta's laboratory at
      Predicta Biosciences
      750 Main Street, Lab 413
      Cambridge, MA 02139
      within 24 hours of specimen collection.
  • What supporting documentation is needed?
    We request clinical notes (including treatment history, prior histologic, and cytogenetic findings, as well as a FISH report, if available) to aid in the pathologist’s review.
  • Which patients are ideal candidates for GenoPredicta™?
    GenoPredicta™ is suitable for:
    • Newly diagnosed patients
    • Relapsed/refractory patients
    • Patients being considered for clinical trials
    • For diagnosis, monitoring and therapy selection purposes
  • How long does it take to receive the results?
    The average report is delivered within 14-28 days.
  • What is the cost of the test?
    GenoPredicta™ is in its Early Access Program, so there are currently no fees.
  • Are you CLIA certified?
    Predicta Biosciences is currently CLIA-approved. Our CLIA number is 22D2314039.
  • Where can I find more information?
    For additional inquiries, contact genopredicta@predictabiosciences.com
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 in development.
  1. Ask your doctor to order the GenoPredicta™ test.
  2. Your provider will order the GenoPredicta™ test from either a bone marrow or blood sample.
  3. Predicta Biosciences will receive your sample, run the test, and send the test results back to your doctor as a clinical report.
  4. Your doctor will share the genetic information with you and how it changes your therapy or your prognosis.
Frequently asked questions
  • What kind of sample do I need to provide?
    We offer the option of using either a blood or bone marrow sample. GenoPredicta™ is an advanced test that provides results from blood with similarly high accuracy as from bone marrow, but with less discomfort and invasiveness.
  • What will the GenoPredicta™ report tell me?
    The report will show genetic changes that have been detected in your myeloma cells. It may also include information about how your cancer might respond to different treatments.
  • Is this test available in my state?
    The test is available in all states except New York. We’re actively working to expand access.
  • How does my doctor order the test?
    The test must be ordered by a licensed medical provider, who will need to complete a Test Requisition Form (TRF). You can get the form here or by emailing genopredicta@predictabiosciences.com. A test kit is required to complete the TRF and will be mailed to you and/or your provider. Licensed medical professionals can also submit TRFs online using Docusign. Sending a copy of the TRF in advance is optional, but it can help our lab team with planning.
  • Do you need my medical records?
    We request recent clinical notes/summary (including treatment history, prior histologic, and cytogenetic findings, and FISH results if available) to take into consideration in the GenoPredicta™ report and aid in the pathologist’s review.
  • Do I need to include my insurance information?
    Predicta has launched an Early Access Program for its GenoPredicta™ assay. For the duration of this program, Predicta will bill neither public nor private insurers.
  • How much does the test cost?
    Currently, GenoPredicta™ is part of an Early Access Program, so there is no cost for patients.
  • How long will it take to get my results?
    The average report will be delivered within 14-28 days.
  • How can I learn more?
    Contact us at genopredicta@predictabiosciences.com for any questions.