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OGM-Dx Heme One
Clinical Genetic Test
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offered by
Bionano Laboratories
View lab's test page
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GTR Test Accession: Help GTR000604102.2
CANCER
Last updated in GTR: 2024-05-01
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Last annual review date for the lab: 2024-05-02 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Prognostic; Therapeutic management
Conditions (1): Help
Hematologic neoplasm
Chromosomal regions/ Mitochondria (1): Help
Whole genome structural variants
Methods (1): Help
Cytogenetics - Karyotyping: Optical Genome Mapping
Target population: Help
OGMDx HemeOne is a genetic test that utilizes optical genome …
Clinical validity: Help
Not provided
Clinical utility: Help
Establish or confirm diagnosis
Ordering Information
Offered by: Help
Bionano Laboratories
View lab's website
View lab's test page
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Lab contact: Help
Jenna Finley, MS, CGC, Certified Genetic counselor, CGC, Genetic Counselor
[email protected]
How to Order: Help
Please contact [email protected] to discuss the ordering process. The test requisition form can be found on https://bionanolaboratories.com/ogm-dx-hemeone/
Order URL
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Contact policy, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Karyotyping
Optical Genome Mapping
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Prognostic; Therapeutic management
Clinical utility: Help
Establish or confirm diagnosis
View citations (1)

Target population: Help
OGMDx HemeOne is a genetic test that utilizes optical genome mapping to identify diagnostic, prognostic, and therapeutic-related structural variants (SVs) across the genome in suspected, newly diagnosed, or recurrent hematological malignancies.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Identified variants are classified per recommendations provided by ACMG (PMID: 35064925, 34237281, 34503197).

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
Decline to answer.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Decline to answer.
Recommended fields not provided:
Clinical validity, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
The OGM-Dx HemeOne test is a laboratory developed test (LDT) performed using the optical genome mapping assay on the Saphyr® system at Bionano Laboratories (6777 Nancy Ridge Drive, San Diego, CA 92121). The OGM technology is based on specific labeling and mapping of ultra-high molecular weight DNA in nanochannel arrays … View more
Test Platform:
Other
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical validation of the OGM-Dx HemeOne assay was performed at Bionano Laboratories and included a comprehensive assessment of performance characteristics. Overall accuracy, sensitivity, specificity, positive predictive value, and negative predictive value are >99%. Repeatability and reproducibility for the assay are 100% and 96%, respectively. Please note that OGM technology has … View more
Assay limitations: Help
Optical Genome Mapping cannot detect single-nucleotide variants and does not make any claims related to sequence variants or variants not meeting the thresholds of the test that may have potential functional impacts. This method also cannot detect balanced Robertsonian translocations, triploidy or regions with loss of heterozygosity (LOH). For triploidy … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Alternative Assessment
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
Additional Information
Practice guidelines:
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.