Reprogenetics

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Thank you for participating in Reprogenetics surveys. Your input is valuable in helping us to better serve your patients’ needs.

Reprogenetics is preparing to distribute a new hereditary marker for elevated recurrent pregnancy loss (RPL) risk and would like to know your opinion.

Background information

• The M2 haplotype of the ANXA5 promoter is a marker for predisposition to early fetal loss (particularly 10 to13 weeks) and maternal and fetal complications in pregnancy.

• Miscarriage risk: Compared to unselected controls M2 carriers have a two-fold increased risk of two previous miscarriages and 3-fold increase of three previous miscarriages. The miscarriage risk is four-fold higher when compared to women with successful pregnancies and no history of pregnancy losses.

• Risk of loss is the same whether the female OR the biological male partner (this includes sperm donors) is a carrier.

• The M2 haplotype is present in 15-19% of European women and at a lower incidence in Japanese. It is also present in Africans at an unknown frequency.

• IVF patients have a significantly higher incidence of M2 haplotype (22%) compared to the general population (15%) and a 2.5-fold increase compared to women with successful pregnancies and no history of pregnancy losses (8.5%).

• In addition, carriers have a twofold higher risk for pregnancy related hypertensive disorders, GH and PE, and a 3-fold risk increase of maternal VTE.

• The test for the M2 haplotype will be approved by the FDA through a 510K application.

• Reprogenetics results show that RPL patients miscarry only £10% after PGD with aCGH. RPL patients who are not carriers of the M2 haplotype would have a greater indication for PGD.

Treatment for carriers of M2 haplotype

Treatment with Low molecular weight heparin (LMWH) is recommended from 6 weeks of pregnancy once a fetal heart beat has been observed. Also, PGD to screen for the M2 haplotype and chromosome abnormalities can be recommended for carriers undergoing IVF since it is the embryo that will generate the affected placenta.

Price of the test

$300 to $400 per couple, through Reprogenetics.

Sample preparation

DNA from cheek swab or extracted from blood and sent to Reprogenetics.