Is papSeek safe?

Your safety and the safety of your baby is our highest priority.

What is a Pap smear procedure? 

A Pap smear, using a standard cytobrush, is taken from the front portion (1.5-2 cm) of the cervical canal, far away from the fetus. This method is normally used to detect the presence of cancerous cells in the cervix. The same collection method can be used to obtain fetal cells that are naturally present at the same location during pregnancy. The brush touches the inner wall of the cervix collecting maternal cells along with the fetal cells. Most medical professionals in the field know how to perform this simple procedure, since it is already commonly performed during pregnancy (see References, below).

What are the risks of the Pap procedure? 

Potential risks to the mother, although very uncommon, include light cervical spotting and sometimes minor bleeding from the tissue in the cervix. If you have been experiencing any bleeding and or discomfort before the procedure, we advice you to talk to your doctor who may recommend that you not receive a Pap smear at that time. 

Although prolonged bleeding does not normally occur after the Pap procedure, if this should happen, we advise you to consult your doctor immediately.  

What are the risks of Pap sampling to the baby?

Based on past and current research from independent studies (not including our own investigators) a Pap smear during pregnancy can be considered safe for both the mother and the fetus.

What does safe mean?

In medical terms, safe means that statistically women receiving a Pap smear during pregnancy have no increased risk of an abnormal pregnancy outcome compared to women who received no Pap smear during pregnancy. 

Studies have been performed around the globe supporting this notion. Please review the following references, to build your own opinion based on years of research.

References

Paraiso MF, Brady K, Helmchen R, Roat TW. Evaluation of the endocervical Cytobrush and Cervex-Brush in pregnant women. Obstet Gynecol. 1994;84(4):539-43. Epub 1994/10/01. PubMed PMID: 8090390.

Holt J, Stiltner L, Jamieson B, Fashner J. Clinical inquiries. Should a nylon brush be used for Pap smears from pregnant women? J Fam Pract. 2005;54(5):463-4. Epub 2005/05/04. doi: jfp_0505_5405n. PubMed PMID: 15865907.

Orr JW, Jr., Barrett JM, Orr PF, Holloway RW, Holimon JL. The efficacy and safety of the cytobrush during pregnancy. Gynecol Oncol. 1992;44(3):260-2. Epub 1992/03/11. PubMed PMID: 1541438.

Rivlin ME, Woodliff JM, Bowlin RB, Moore JL, Jr., Martin RW, Grossman JH, 3rd, Morrison JC. Comparison of cytobrush and cotton swab for Papanicolaou smears in pregnancy. J Reprod Med. 1993;38(2):147-50. Epub 1993/02/01. PubMed PMID: 8445608.

Our own research is soon to be published, with over 1000 patients participating in a clinical research setting at Wayne State University. Volunteers did not experience an increase in abnormal pregnancy outcomes (for example, miscarriage) compared to the national average of approximately 5%. 

It is important to note that some pregnancies naturally have an unsuccessful outcome. There are many reasons for this to occur. The risk of miscarriage in the first three month is the highest since pregnancy is still becoming established and the mother's body must decide if it will be able to support a baby. This is why many women do not announce their pregnancy in the first 3 month when the outcome is still uncertain.

We encourage you to have a conversation with your doctor about the wonderful experience of pregnancy, as well as the problems that can potentially occur. Being fully educated and informed based on medical knowledge will give you confidence, reduce your stress levels, and let you focus on the joy of producing another human life.

When can the procedure be performed?

The method works best as early as 5 weeks up to 20 weeks of pregnancy. Most of our clients have the test performed at their first Obstetrician visit, which often involves a specculum exam.

What to do if I am concerned about my babies health?

The data we provide to you is for information purposes only, and not intended to guide any medical decisions. If you have any concerns, contact your health care professional.

Since we are only conducting a test, we are not allowed by law to provide any information to you that would result in a medical decision. Only your health care professional can provide medical guidance. If you have any medical questions or concerns after receiving your test result, please contact your health care professional. Please review our important disclaimer section. 

What is your shipping policy?

We will soon be able to ship sampling kits to you or your doctor. The package will include two cytobrushes and a small container with preservative to stabilize your sample during shipping. Your doctor may already have papSeek kits in the office, through a prior arrangement with our company. If not, we can send a kit directly to you. We provide each kit with a shipping box and an overnight return label to ensure quick delivery to our laboratory.

What happens at the doctor office?

Your doctor will educate you about the procedure, ask you about your health, and determine if you had any recent vaginal bleeding or spotting. If the doctor considers the procedure safe for you, a Pap procedure will be done with the support of a speculum. The doctor will use both cytobrushes by inserting them, one at a time, into the cervical canal (approx. 1.5 -2 cm), with one or two full rotations. Some women might feel a minor discomfort. The brush and its content will be rinsed into the storage solution and scrapped using the provided spatula. This will be repeated with the second brush. The procedure should produce a somewhat cloudy solution due to the release of cells and mucus from the cytobrush.

Insufficient cell material can result in unsuccessful testing. If performed correctly, over 90% of all samples produce good results. We provide the doctors with educational material in each kit to ensure the procedure is performed optimally. We have, as well, support staff to advise health care professionals if needed.

What happens to my sample?

After an overnight shipment, the sample arrives at our laboratory and will undergo various quality assessments. The fetal cells will be separated from the maternal cells, and DNA will be isolated from both fractions. The DNA quality and amount will be determined, and the molecular test performed. The outcome will be a report that will provide a probability for what the genetic status of the fetus is. 

What happens to any left over samples? 

Any given sample will be stored for 30 days in case it is necessary to re-run the test. After 30 days the sample will be destroyed unless the client provides consent to use the de-identified sample for our research.

What happens to my personal data? 

Personal data safety is critical for us. All data is de-identified by removing all personal data from the sample and providing each client a unique ID, which will be used to obtain results once the test is concluded. We are HIPPA compliant, which means that we follow all regulatory standards protecting private information.

Under no circumstances will your data be shared with anyone without your consent. At any time, clients can request that their data be removed from a research project. In that case, all data and stored samples will be discarded within 7 days.

How will I be able to view the data?

At this early stage of research and clinical test development, data will be provided to your physician directly. As a medical professional, they will be able to educate you regarding test results, and counsel you or direct you to a genetic counselor.

 

What are the limitations? 

Each test has its limitations. For papSeek, the major limitation is the amount and quality of fetal DNA that can be successfully isolated from a sample. The more DNA available, the more accurate the results. Although we are currently able to use approximately 90% of all samples, some samples simply do not perform well. The reason for this can be poor sample collection. In those cases, we offer another sampling kit to the healthcare professional and the opportunity to repeat the test. 

Another limitation is the potential inaccuracies due to the technical limitations of the test. Although our test shows exceptional performance, there is always a chance that a sample may fail. If in doubt, we always suggest re-sampling. Other independent tests that are currently available can be used to validate results.

How about research?

Our company is research driven and the tests we offer are under constant development to provide even more reliable information to clients.

As part of our research efforts, we invite each client to voluntarily participate in research to help future mothers and their babies. This is necessary since some genetic changes are very rare and require large population studies to validate new tests that will become future clinical tools.

Generally, patients are able to donate unused portions of their sample for additional testing and storage at no costs and with no personal benefit. The sample will be de-identified so it can only be linked back to the client with their consent. Under no circumstances will your data be shared with anyone you did not give your consent. At any time, patients can request to be removed from the research project, and all data and stored sample will be discarded. 

The opportunity to participate in research will become available online at a later time. In the meantime, if you have interest in contributing to research please feel free to contact us at info@papSeek.com.

Who are you guys ? 

A.R.T. - Advanced Reproductive Testing is a Detroit-based company that is owned by two scientists, Dr. Randall Armant and Dr. Sascha Drewlo. Combined, both have decades of academic experience in human reproductive biology, particularly as it relates to implantation and placentation, as well as detection of high risk pregnancies and novel intervention strategies. Together, they have published over 150 articles in peer reviewed medical journals, including the Lancet and Science Translational Medicine.

From a research endeavor, our intention has been to improve lives in our community and globally. Supported by grants from the National institute of Health, University resources, and industry collaborators, we aim to provide personalized pregnancy care for every woman and her baby. 

We are dedicated to provide high quality information using state of the art technology and the latest research findings. Our hope is to assist families and their physicians with information that will ultimately support successful pregnancy outcomes. 

 

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