about Baebies and Eli

What is Eli?
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Eli is an expanded newborn screening service that tests for 32 medical conditions for which there is an early treatment or intervention. The Eli test extends beyond conditions that are included in many state public health programs. Eli requires both a dried blood spot (DBS) and saliva sample from your child. The sample collections are done by a doctor or nurse at the hospital or first visit to your pediatrician. The dried blood spot collection is a simple heel stick - the same method that hospitals use to test newborn babies for state newborn screening programs.

Is Eli a prenatal test?
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No. Eli is a test for babies after they are born, typically within the first several weeks of life.

Who is Baebies?
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Eli was conceived by Baebies, an innovative company focused on improving infant healthcare across the globe. The Baebies technical team are leaders in their fields, focused on developing technologies that allow for the earliest, most accurate detection of conditions with a treatment or intervention. That means Eli can give you peace of mind, catch serious conditions and disorders, and help ensure more babies have healthier outcomes. At Baebies, we’re concerned that more than 100 million babies born worldwide each year are not screened for even the most basic treatable congenital disorders. Catching those conditions early is the key to the best possible outcomes.

Where is Baebies located?
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Baebies’ headquarters and laboratory are located in Durham, North Carolina. However, we accept tests and samples from anywhere in the United States.

newborn screening

What is newborn screening?
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In the United States, nearly every child is tested for a set of medical conditions shortly after birth, commonly known as newborn screening (NBS). This public health program helps identify babies who may be at an increased risk for serious, but treatable, conditions in childhood.

Most babies who are born with these conditions appear healthy at first. Without early screening, a condition may not be discovered until symptoms appear, and damage may have already occurred inside the baby’s body. It may then be too late to prevent serious health consequences. Newborn screening helps parents, pediatricians and hospital health care workers identify conditions early in life, so that treatment can be started as early as possible.

Each state determines which conditions babies will be screened for, so different states test for different conditions. In general, most states screen for at least 31 conditions that are recommended by the federal government and 26 additional secondary conditions. There are 35 conditions on the Recommended Uniform Screening Panel. You can learn more about newborn screening and which conditions your state screens for at babysfirsttest.org

What is expanded newborn screening?
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Expanded newborn screening tests for conditions that may not be covered by all state newborn screening programs. Eli is an expanded newborn screening service offered by Baebies that tests for 32 additional conditions. Eli is for parents who seek to know as much as they can about their baby’s health and wellbeing. Eli is additive, not repetitive, to the conditions screened for by state public health laboratories.

What are the benefits of expanded newborn screening?
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For expecting and new families, Eli offers the knowledge you need to make informed decisions about your child’s health, and the peace of mind so you can embrace the joy of this exciting time. Eli expanded newborn screening helps identify actionable conditions, enabling earlier treatment or intervention for better health outcomes. By providing a simple test, results within a week, and genetic counselors to help guide care, Eli is supporting parents and empowering families to live their happiest, healthiest lives.

How is Eli different or similar to state public health newborn screening?
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Most (but not all) states screen for at least the conditions on the federal government’s Recommended Uniform Screening Panel (or RUSP). States may test for additional conditions on a state-by-state basis. The number and type of conditions tested varies depending on which state you live in. However, all state newborn tests differ from Eli in two key ways:

  1. Eli extends beyond the newborn screening performed in most state programs, testing for conditions that are not on the RUSP (or for conditions that are on the RUSP, but are not yet being tested in all states).
  2. Eli uses targeted next generation DNA sequencing and a set of biochemical tests to analyze your baby’s risk for genetic conditions where treatment or intervention is possible. The combination of the DNA and biochemical testing helps ensure the most accurate results.

How is Eli different from other newborn screening tests, such as hearing tests?
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Eli screens for conditions caused by DNA (genetic) changes. Babies with these conditions may appear to be healthy at birth, and may not show symptoms on health screens that are done shortly after birth. The types of conditions on the Eli test can run in a family, but most often there is no family history of the condition. Eli can also detect new DNA changes, which were not inherited from either parent. For this reason, Eli screening can provide useful information about your child’s health, beyond other types of screening tests.

the Eli screen

What newborn conditions does Eli test for?
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Eli screens for 32 actionable conditions, including relatively common conditions like congenital cytomegalovirus (cCMV) present in 1 in 140 babies and rare diseases like Sanfilippo and Pompe Disease. We’re actively expanding the number of conditions on the panel based on the latest medical developments and breakthroughs. When it comes to the future of your baby and your family, you can be confident that Eli delivers the most advanced and reliable screening. A complete list of conditions can be found here.

Why is it important to know if my baby is at risk for any of these conditions?
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All of the conditions on the Eli screen have an actionable intervention. This means that dietary changes, FDA-approved medications, or therapies that are in final phases of clinical trials can treat the condition or lessen the symptoms. In many cases, early treatment is key to a better long term outcome.

What genes does the Eli screen test?
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You can find the full list of genes and conditions that are included on the Eli tests here.

What biochemical tests are included with the Eli screen?
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Some of the 32 treatable conditions on the Eli screen are tested for by measuring certain proteins in the blood. The conditions where these biochemical tests are used include Duchenne muscular dystrophy, Pompe disease, Gaucher disease, Fabry disease, Krabbe disease, Hurler-Scheie syndrome and Hunter syndrome.

Where is the testing done?
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All Eli screening is performed in-house at the Baebies lab in North Carolina.

Is Eli screening run in a CLIA certified laboratory?
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Yes, Baebies’ in-house lab is CLIA-certified.

Ordering and Completing Eli

How do I order Eli?
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Ordering Eli is a simple online process. You can get started by clicking here.

When is the right time to order Eli?
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Newborn screening provides the most benefit when it occurs very soon after birth. We recommend that you order Eli any time before your due date or soon after your child’s birth (the tests are most effective within the first 21 days of life). Bring the kit to your newborn’s first pediatric visit.

My baby is more than a few weeks old. Can I still order Eli for him/her?
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Eli can be ordered at anytime during the first year of a baby’s life. However, newborn screening is most effective when it is performed very soon after birth, when action can be taken to prevent the effects of a positive screen, before symptoms occur. Viral results, such as cCMV, become less accurate in babies older than three weeks.

Who can order Eli?
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Anyone can order Eli, including expecting and new parents, family members, or friends. Eli makes a thoughtful gift for parents-to-be.

I received Eli as a gift. What do I do next?
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Congratulations on having such awesome friends and family. They already care about the health and wellbeing of your baby. The first step will be to register your Eli sample collection kit that you received as a gift. To register your gift kit and prepare for the test, click here .

What is needed from my baby for this test?
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Eli requires both a dried blood spot (DBS) and saliva sample from your baby. The sample collections are done by a doctor or nurse. The dried blood spot collection is a simple heel stick - the same method that hospitals use to test newborn babies for state newborn screening programs. Everything needed for the sample collection is included in the Eli kit.

How is the Eli test done on my baby?
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Eli makes it simple. Bring the kit to the hospital at delivery, or to your newborn’s first pediatric visit. Your trusted nurse or doctor will do the blood spot and saliva sample collection and send the samples to our lab in the provided, postage-paid box. You’ll have the results in about a week, giving you the information you need to make informed decisions about the health of your precious new arrival.

Eli results

How long does it take to get my results?
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The Eli screening takes 7 business days to complete from the time we receive your baby’s sample at our lab. Once ready, you will receive your results via your secure Eli online portal. You may also be contacted by a genetic counselor or doctor from Genome Medical to discuss your results.

What will my test results tell me?
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The Eli screen results will indicate if your baby is at risk to have, or is a carrier for, one of the 32 conditions included in the test. The types of results that you could receive include:

  • a negative result (meaning that the test does not indicate a risk for your baby to have one of the conditions; the results will note if your baby may be a carrier)
  • a positive result (meaning that the test indicates there is a risk for a specific condition in your baby)
  • an indeterminate result (meaning that the test is inconclusive and additional follow up is needed to fully understand the risk for that condition in your baby.)

If your baby’s test results indicate anything other than all negative results, you will be contacted by a genetic counselor from Genome Medical to discuss the result and the next steps that need to be taken.

How will the test results be delivered?
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You will receive an email notification followed by access to your baby’s test results via your secure Eli customer portal. This is the same portal that you set up when ordering or registering Eli for your baby. You can download your baby’s test results from the portal.

If your baby’s results show a positive screen, meaning that your baby may have one of the conditions screened for by Eli, then you will receive a call from a genetic counselor at Genome Medical to discuss your results.

Will someone be available to help me understand my results?
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Yes. Whether your results are screen positive or something else, you can talk with a genetic counselor at Genome Medical at any time.

Genetic Counseling

What is a genetic counselor?
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Genetic counselors are graduate-level trained experts in genetics who specialize in communicating complex medical information to individuals and their families. Some genetic counselors are particularly knowledgeable about the diagnosis and treatment of newborn genetic and viral health conditions.

What training do genetic counselors have?
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Genetic counselors have masters or PhD graduate degrees. In addition, genetic counselors are board certified by the American Board of Genetic Counseling, and in many states are required to be licensed based on local laws.

How can a genetic counselor help me?
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A genetic counselor can help provide support during your journey with Eli at several different points:

  • Before you order Eli: Trying to figure out if Eli is right for you and your family? A genetic counselor can explain details about the Eli test, and answer any questions you have.
  • Before you’ve received results: A genetic counselor can answer any questions you have about the testing process, and help you understand what to expect from the results.
  • After your results are ready: A genetic counselor can explain exactly what the results mean for your baby and your family, and talk to you about next steps to take with your doctor.

What is Genome Medical?
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Genome Medical is a telegenomics company with a national network of genetic experts, including genetic counselors, geneticists, and primary care physicians. The specialists at Genome Medical will provide expert guidance throughout your testing journey with Eli by reviewing your baby’s medical information, authorizing the test, and providing genetic counseling consultations by phone or video at no additional charge to you. The genetic counselors at Genome Medical are board certified and have expertise in the diagnosis and treatment of newborn conditions.

How can I reach a genetic counselor to talk about the Eli screen?
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If you have general questions about Eli before you receive your results, we encourage you to contact Baebies at EliCares@eliScreen.com or 1-833-ELI-1234 (1-833-354-1234). Once your Eli results are ready, you can choose to discuss the results with a genetic counselor at Genome Medical by contacting coordinator@genomemedical.com or 1-877-688-0992.

After results

Will my doctor receive a copy of my results?
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Once your results are ready, you can download and print a copy to share with your pediatrician. In some cases, Genome Medical may also share a copy of the results with your pediatrician.

What do I do with my test results?
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If your baby’s Eli results are screen negative, you can rest assured with very high accuracy that your baby is not at risk for the conditions on the Eli screen. You can share the result with your pediatrician, but no follow up steps are needed.

If your baby’s Eli results are screen positive or indeterminate, then you should call your pediatrician’s office right away to make sure they have reviewed the results and set up an appointment for your baby to proceed with next steps.

Insurance Billing

Can I use my health insurance benefits to purchase this product?
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At this time, Eli can be purchased online using a credit card. Some flexible health spending accounts allow tests such as Eli to be purchased using the money from that account. Also, some people may choose to submit the test receipt to their health insurance company after they buy. However, Baebies does not directly bill health insurance for the Eli test. We recommend that you contact your health insurer or FSA provider if you have questions about getting Eli covered.

Privacy and Security

Will my personal information be protected?
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Absolutely. Baebies and our Eli customer portal conform to the highest standards in data security and protection. Our encrypted databases and secure online portal meet or exceed all industry and government standards for protection. Rest assured that at Baebies, we have your privacy at the top of mind.

Will my baby’s Eli results be shared with anyone besides me?
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Your Eli results will be shared with the clinical team at Genome Medical, our partner organization. The physicians and genetic counselors at Genome Medical may decide to contact you to discuss the results as part of that process. Certain medically important results for your baby may also be shared by Genome Medical with your pediatrician. We want to ensure that if next steps are needed, you and your medical team are well informed.

Are Baebies and their partner Genome Medical HIPAA compliant?
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Yes. Both Baebies and Genome Medical uphold the highest privacy standards, and are HIPAA compliant.

Account Management

How do I change the password to my Eli customer portal?
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To change your Eli portal password, first sign into your Eli account. Under your account information section, you will see a link to change your password. If you forgot your password, and need to gain access to your account, simply click on the forgot password link on the signin page and follow the prompts.

Can I grant my spouse or someone else access to my account too?
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Only you can access your secure Eli customer portal. If you’d like to share your baby’s results with a family member or your doctor, you can download the result report for printing.

How do I delete my Eli portal/account?
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You can deactivate your Eli portal by contacting Baebies customer support at EliCares@eliScreens.com. Deactivating your account means that your baby’s results and information will no longer be accessible via the Eli portal. If you would like to have your baby’s results completely deleted from your Eli portal, you can also request this. But please note that once results are deleted, they cannot be recovered or reactivated in the future.