Primary and Cultured Cells

Test and know, if the medication is putting the baby at risk

$1,300.00

$1,300.00
$1,300.00
$1,300.00

Description

OverviewWhy we want you to testOur test ApplicationsGet startedData and Publications

Pregnant women currently have the choice to stop medications and putting themselves at risk – or keep taking them and potentially putting their baby at risk.

Using Epiblasts for drug toxicity screening can identify medication that are unhealthy for pregnant women and if needed our tests can show safer alternatives.

Little is know about your medication

Research done by the Centers for Disease Control and Prevention found that of the 54 most common medications pregnant women use in the first trimester, 63% had very limited risk data and only 4% had excellent data.

We test your medication

To see if it stops epiblast development, weakens the amniotic sac, or stops primitive streak development. These deformities can cause stillbirths or miscarriages. We screen for these problems with our Epiblast model.

The fact that certain drugs given during pregnancy may prove harmful to the unborn child is one of the classical problems in medical treatment. In the 1960’s pregnant woman who ingested thalidomide gave birth to children with phocomelia (Smithells & Newman, 1992). Some of these drugs like phocomelia directly effect embryonic development, but some drug effects are more subtle and relate to later life health events (also known as embryonic origin of diseases) (Sachdeva, Patel, & Patel, 2009). These kinds of effects led the US Food and Drug Administration to establish strict regulations regarding drug labeling, the use of medications in pregnancy, demonstrations of safety and efficacy of any drug before it becomes commercially available (Food and Drug Administration, 2014)

During pregnancy 97% of the woman took at least one medication with 95% taking a medication in the first trimester (Haas, 2018). Even though strict regulations put in place by the FDA, unfortunately a study in 2001 found that there was not enough information about the risk or safety of 91% medications approved by FDA, between 1980 and 2000 when taken during pregnancy (Lo & Friedman, 2002). Another study between 2000 and 2010 showed the same gap in knowledge (Adam, Polifka, & Friedman, 2011). This is because pregnant women are usually excluded from medical trials.

Fear of causing fetal harm and death through medication use in pregnancy, makes it difficult for women and health care providers to decide whether to use medications during pregnancy or not (Ward, 2001). Because of these ethical considerations, researchers like Gerald Briggs believe that this problem will not be resolved in the near future (Briggs et al., 2015).

Medication safety information in pregnancy is at the moment obtained through case reports, epidemiological studies and animal studies; all of which have limitations, that make determining risks of a drug use during pregnancy difficult (Ward, 2001). We at Cellulim aim to determine risks of a drug during pregnancy by producing and selling synthetic human epiblasts generated solely from embryonic stem cells or induced pluripotent stem cells. This approach while generating large numbers of synthetic human epiblasts, used as test solutions to problems of pregnancy failure and the embryonic origin of diseases.

Get started in a few simple steps.

Medication Kit Medication Kit
Order a kit with
easy-to-follow instructions (we are committed to maintaining the privacy of all personal information entrusted to us).
Medication Kit Activation Medication Kit Activation
Activate your kit and return your medication sample in a prepaid package to our state-of-the-art lab.
Test Results Test Results
In roughly 6-8 weeks your results will be ready online.
Note: lab processing times may be increased due to high demand.
Adam, M. P., Polifka, J. E., & Friedman, J. M. (2011, August). Evolving knowledge of the teratogenicity of medications in human pregnancy. In American Journal of Medical Genetics Part C: Seminars in Medical Genetics (Vol. 157, No. 3, pp. 175-182). Wiley Subscription Services, Inc., A Wiley Company.

Haas, D. M., Marsh, D. J., Dang, D. T., Parker, C. B., Wing, D. A., Simhan, H. N., … & Parry, S. (2018). Prescription and Other Medication Use in Pregnancy. Obstetrics & Gynecology, 131(5), 789-798.

Food and Drug Administration. (2014) Content and format of labeling for human prescription drug and biological products: requirements for pregnancy and lactation labeling. Fed Regist, 79(233), 72064–72103.

Lo, W. Y., & Friedman, J. M. (2002). Teratogenicity of recently introduced medications in human pregnancy. Obstetrics & Gynecology, 100(3), 465-473.

Sachdeva, P., Patel, B. G., & Patel, B. K. (2009). Drug use in pregnancy; a point to ponder!. Indian journal of pharmaceutical sciences, 71(1), 1.

Smithells, R. W., & Newman, C. G. (1992). Recognition of thalidomide defects. Journal of medical genetics, 29(10), 716.