The California Prenatal Screening (PNS) Program is a comprehensive public health service that makes prenatal screening available to all pregnant individuals in the state who want it. The GDSP cfDNA Panel is available as part of this program.
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The GDSP (Genetic Disease Screening Program) cfDNA Panel is a cell-free DNA test that can screen for increased risk of trisomy 21, trisomy 18 and trisomy 13, which are fetal chromosomal abnormalities that may cause birth defects. It can also screen for fetal sex, if elected. Supplemental cfDNA screening is also available for sex chromosome aneuploidies (SCAs) and/or microdeletions. The GDSP cfDNA Panel, as well as the supplemental tests for SCA and/or microdeletions, are “screening” tests, not a diagnostic tests, and therefore all positive (i.e., increased risk) results should be followed by genetic counseling and further diagnostic testing and procedures, when clinically indicated. Pregnancy management decisions should not be based on the results of a cfDNA test alone. As with any test, there may be false positives or false negatives. The positive predictive value of the screening test varies by genetic marker, and may be lower for rare conditions. Performance data for the GDSP cfDNA Panel and for the supplemental screening tests may be obtained by contacting Quest Diagnostics at 1.866.GENE.INFO (1.866.436.3463). The GDSP cfDNA Panel and the supplemental screening tests are laboratory-developed tests that have been developed and validated, pursuant to the Clinical Laboratory Improvements Amendments of 1988 (CLIA), and as such they have not been reviewed by FDA. |
Quest Diagnostics has over 30 years of experience in providing prenatal screening and diagnostic testing to help you manage your patients’ care more effectively. We offer more than 900 genetic tests using some of the newest technologies available today.
GDSP cfDNA Panel - Strong performance
High sensitivity and specificity during verification/validation testing and in the real world*
GDSP cfDNA Panel - Strong performance
High sensitivity and specificity during verification/validation testing and in the real world*
Screening test results will be provided through the CalGenetic Portal.
Results are typically available in 7-10 days. If you have any questions about the status of your order, please reach out to the California Department of Public Health Clinical Care Coordinators.
Additional screening and diagnostic tests including for cystic fibrosis, spinal muscular atrophy, fragile X, and more, can be ordered directly from Quest Diagnostics via your Quanum account, interfaced EHR, or Quest Diagnostics paper requisition. For a full list of tests, please visit our Test Directory.
Quest Diagnostics has more than 400 Patient Service Centers (PSCs) in California, giving your patients the accessibility they need.
Quest has a team of genetic counselors ready to answer your questions. To reach a genetic counselor, call 1.866.GENE.INFO (1.866.436.3463) Monday through Friday from 5:30 AM to 5:30 PM PT.
We offer a broad range of testing options that includes cytogenetic testing on amniocentesis and CVS specimens. If your patients need follow-up diagnostic testing, you can feel comfortable knowing the results will be analyzed by the same laboratory.
With peer-reviewed publications and research studies, Quest continues to innovate and help shape women’s healthcare.
1 | Guy C, Haji-Sheikhi F, Rowland CM, et al. Prenatal cell-free DNA screening for fetal aneuploidy in pregnant women at average or high risk: Results from a large US clinical laboratory. Mol Genet Genomic Med. 2019;7(3):e545. doi:10.1002/mgg3.545 (finding a no-call rate of 3.5%; several authors affiliated with Quest Diagnostics); “No call rate” refers to the percentage of samples for which results could not be reported. |