Noninvasive Fetal Genotyping by Droplet Digital PCR to Identify Maternally Inherited Monogenic Diabetes Variants

diagnostic testing
genetic testing
Authors

Caswell, R. C.

Snowsill, T.

Houghton, J. A. L.

Chakera, A. J.

Shepherd, M. H.

Laver, T. W.

Knight, B. A.

Wright, D.

Hattersley, A. T.

Ellard, S.

Published

Jul 2020

Abstract

BACKGROUND: Babies of women with heterozygous pathogenic glucokinase (GCK) variants causing mild fasting hyperglycemia are at risk of macrosomia if they do not inherit the variant. Conversely, babies who inherit a pathogenic hepatocyte nuclear factor 4α (HNF4A) diabetes variant are at increased risk of high birth weight. Noninvasive fetal genotyping for maternal pathogenic variants would inform pregnancy management. METHODS: Droplet digital PCR was used to quantify reference and variant alleles in cell-free DNA extracted from blood from 38 pregnant women heterozygous for a GCK or HNF4A variant and to determine fetal fraction by measurement of informative maternal and paternal variants. Droplet numbers positive for the reference/alternate allele together with the fetal fraction were used in a Bayesian analysis to derive probability for the fetal genotype. The babies’ genotypes were ascertained postnatally by Sanger sequencing. RESULTS: Droplet digital PCR assays for GCK or HNF4A variants were validated for testing in all 38 pregnancies. Fetal fraction of ≥2% was demonstrated in at least 1 cell-free DNA sample from 33 pregnancies. A threshold of ≥0.95 for calling homozygous reference genotypes and ≤0.05 for heterozygous fetal genotypes allowed correct genotype calls for all 33 pregnancies with no false-positive results. In 30 of 33 pregnancies, a result was obtained from a single blood sample. CONCLUSIONS: This assay can be used to identify pregnancies at risk of macrosomia due to maternal monogenic diabetes variants.

Citation

BibTeX citation:
@article{r.c.2020,
  author = {Caswell, R. C. and Snowsill, T. and Houghton, J. A. L. and
    Chakera, A. J. and Shepherd, M. H. and Laver, T. W. and Knight, B.
    A. and Wright, D. and Hattersley, A. T. and Ellard, S.},
  title = {Noninvasive {Fetal} {Genotyping} by {Droplet} {Digital} {PCR}
    to {Identify} {Maternally} {Inherited} {Monogenic} {Diabetes}
    {Variants}},
  journal = {Clinical Chemistry},
  volume = {66},
  number = {7},
  pages = {958-965},
  date = {2020-07-01},
  url = {https://tristansnowsill.co.uk/noninvasive-fetal-genotyping-by-droplet-digital-pcr.html},
  doi = {10.1093/clinchem/hvaa104},
  langid = {en},
  abstract = {BACKGROUND: Babies of women with heterozygous pathogenic
    glucokinase (GCK) variants causing mild fasting hyperglycemia are at
    risk of macrosomia if they do not inherit the variant. Conversely,
    babies who inherit a pathogenic hepatocyte nuclear factor 4α (HNF4A)
    diabetes variant are at increased risk of high birth weight.
    Noninvasive fetal genotyping for maternal pathogenic variants would
    inform pregnancy management. METHODS: Droplet digital PCR was used
    to quantify reference and variant alleles in cell-free DNA extracted
    from blood from 38 pregnant women heterozygous for a GCK or HNF4A
    variant and to determine fetal fraction by measurement of
    informative maternal and paternal variants. Droplet numbers positive
    for the reference/alternate allele together with the fetal fraction
    were used in a Bayesian analysis to derive probability for the fetal
    genotype. The babies’ genotypes were ascertained postnatally by
    Sanger sequencing. RESULTS: Droplet digital PCR assays for GCK or
    HNF4A variants were validated for testing in all 38 pregnancies.
    Fetal fraction of ≥2\% was demonstrated in at least 1 cell-free DNA
    sample from 33 pregnancies. A threshold of ≥0.95 for calling
    homozygous reference genotypes and ≤0.05 for heterozygous fetal
    genotypes allowed correct genotype calls for all 33 pregnancies with
    no false-positive results. In 30 of 33 pregnancies, a result was
    obtained from a single blood sample. CONCLUSIONS: This assay can be
    used to identify pregnancies at risk of macrosomia due to maternal
    monogenic diabetes variants.}
}
For attribution, please cite this work as:
Caswell, R. C., Snowsill, T., Houghton, J. A. L., Chakera, A. J., Shepherd, M. H., Laver, T. W., Knight, B. A., Wright, D., Hattersley, A. T., and Ellard, S. 2020. “Noninvasive Fetal Genotyping by Droplet Digital PCR to Identify Maternally Inherited Monogenic Diabetes Variants.” Clinical Chemistry 66 (7): 958–65. https://doi.org/10.1093/clinchem/hvaa104.