NeoLAB® Liquid Alternatives to Biopsy for Hematologic Diseases – Questions and Answers

Commonly asked questions about getting started and applying results to patient care

 

When to Order Plasma vs. Blood or Bone Marrow

Sometimes I send blood for NeoTYPE Hematologic Profiles. Should I always order NeoLAB® to test plasma rather than testing blood?

  • Whole blood analyses are acceptable if circulating blasts or abnormal cells are present. NeoLAB® is more accurate in such cases and may provide greater sensitivity.
 

Test Performance

How were your tests validated?

  • Over a decade of peer-reviewed work has proven the increased sensitivity of plasma cell-free nucleic acid detection in hematologic cancers. (See References). Performed in our CAP-accredited, CLIA-approved laboratory, our tests employ positive controls and proprietary enhancements to nucleic acid extraction and sequencing techniques for accurate and reliable results.
 

Is NeoLAB® done by next-gen sequencing?

  • The molecular methodology used is the one optimal for detection of the mutation(s) in question and overall efficiency and cost-effectiveness of the test. The major method of the AML and MDS/CMML Profiles is next-gen sequencing. PML-RARA, inv(16), and RUNX1-RUNX1T1 require RT-PCR. Other methods used include Sanger sequencing, high sensitivity Sanger sequencing, and fragment analysis.
 

What is the concordance of mutation profiles in bone marrow compared to blood and compared to plasma?

  • Multiple studies show plasma to be a more sensitive indicator of both the presence and level (burden) of mutations than blood or bone marrow. Differences in detection between the sample types will vary by patient, biomarker, and stage of disease. Please refer to articles in References for specific studies.
 

Applying NeoLAB® to Patient Care

What can be inferred about increases or decreases in the percentage of mutant alleles between repeated plasma tests? How do I use this for monitoring?

  • Most but not all biomarkers in these NeoLAB® tests are reported quantitatively. Levels of abnormality are shown as percentages of mutant DNA copies amongst total copies of that gene region. Always look at the pattern of increase or decrease in levels of an identified abnormality between repeated samples, rather than focusing on the level at a single time point. For qualitative NeoLAB® results, look for positive results to shift to negative results as the abnormality is eliminated or decreases below the test’s technical limits.
 

Test Logistics and References

What is the specimen type?

  • Though the test is run on plasma, we require whole blood in standard anticoagulant tubes – 5 cc peripheral blood in EDTA. We will separate the plasma in our lab. We prefer plasma over serum because plasma is not influenced by variation from clotting.
 

Does it matter how many hours or days old the blood sample is when plasma testing is performed?

  • Please try to arrange delivery to NeoGenomics within 48-72 hours of collection. Samples older than this may not be tested.
 

Does insurance cover this testing?

  • We expect insurance coverage for these tests on plasma to be the same as when the test is performed on marrow. With either sample type, coverage varies according to insurance plan and the specific marker(s). Please contact our Billing Department at 866.776.5907, option 2 with specific inquiries.
 

What publications can I read about cell-free biomarker analysis in hematologic diseases?