A hospital in Virginia now offers a genetic service to new parents that could impact clinical pathology laboratories if it develops into a trend

Here’s a first in the rapidly-developing field of pharmacogenomics testing. A hospital in Virginia announced that it would offer a free pharmacogenomics test to newborns. This is a development that will catch the attention of clinical pathologists and medical laboratory professionals at other hospitals across the country.

Inova Women’s Services at the Inova Woman’s Hospital on the Inova Fairfax Medical Campus in Falls Church, VA, has begun offering free MediMap tests to newborns. MediMap is a pharmacogenomics (PGx) test that looks for variations in seven genes that could indicate a child might process certain drugs differently than the majority of the population.

The program is an example of a well-known and often-used marketing tactic: “Buy X and get Y free!” Given the choice between a new free diaper bag and a free, painless test that, as Inova’s website states, “personalizes prescriptions to more effectively treat and manage illnesses in the future,” what new mother would choose the diaper bag?

The MediMap Test Was Developed Within the Inova Health System

The Inova not-for-profit five-hospital network in northern Virginia includes more than 1,700 licensed beds and 16,000 employees. It has the area’s only Level 1 Trauma Center and a Level IV neonatal intensive care unit. It is also home to the Inova Translational Medicine Institute (ITMI), which focuses on genomics research. It was ITMI that developed the MediMap test.

According to the Inova website, Inova offers MediMap “as part of the standard package of services offered to all babies born at Inova Women’s Hospital located at Inova Fairfax Medical Campus.”

The company provides a list of “actionable genes and drugs” included in the panel. There are five categories of pharmaceuticals on the list:

1. Anti-cancer agents
a. Mercaptopurine
b. Thioguanine
2. Cardiovascular drugs
a. Warfarin
b. Clopidogrel
c. Simvastatin
3. Pain
a. Codeine
4. Psychotropic
a. Amitriptyline
b. Citalopram
c. Clomipramine
d. Desipramine
e. Doxepin
f. Escitalopram
g. Fluvoxamine
h. Imipramine
i. Nortriptyline
j. Paroxetine
k. Phenytoin
l. Sertraline
m. Trimipramine
5. Immunologic
a. Tacrolimus
b. Azathioprine

It’s All About Marketing

If offering a genetic test as a marketing tool works for this hospital, it could well signal a change in how consumers feel about such clinical laboratory tests. To date, stories about so-called “designer babies,” people taking extreme measures due to risk, or fears about genetic discrimination have made the general public wary of genomics.

However, Inova reports that 70-80% of the parents delivering newborns at Inova Women’s Hospital have opted to take advantage of the free test. If other hospitals see that this marketing tactic works, and a trend develops, it could signal a change in public perception. In such an event, the MediMap test would be one sentinel event signaling a wider acceptance of genetic testing by consumers.

MediMap is Not Without Controversy

Some experts, however, express concerns about the usefulness of the MediMap panel.

Lainie Ross, MD, PhD, Chair of the American Academy of Pediatrics Section of Bioethics Executive Committee, told Forbes, “We really don’t recommend testing children for conditions or information they won’t need until they’re young adults, or in this case, older adults.”

Ross is the lead author of a report titled “Technical Report: Ethical and Policy Issues in Genetic Testing and Screening of Children,” an American College of Medical Genetics and Genomics (ACMG) policy statement, published in 2013. That report states, “If the medical benefits of a test are uncertain, will not be realized until a later time, or do not clearly outweigh the medical risks, the justification for testing is less compelling.”

Lainie Ross, MD, PhD (above), is Chair of the American Academy of Pediatrics Section of Bioethics Executive Committee, as well as a practicing pediatrician at the University of Chicago Medicine Comer Children’s Hospital. In addition, Ross is a frequent lecturer at national and international conferences on the topic of ethical controversies in medical practice and research. In a Forbes article, Ross stated, “I don’t see what benefit we’re giving this child by giving the parent this information. It’s not going to help the child clinically.” She went on to state, “Given that these medicine[s] are not needed for healthy newborns, this is, in a sense, predictive genetic testing.” (Photo copyright: University of Chicago Medicine.)

Lainie Ross, MD, PhD (above), is Chair of the American Academy of Pediatrics Section of Bioethics Executive Committee, as well as a practicing pediatrician at the University of Chicago Medicine Comer Children’s Hospital. In addition, Ross is a frequent lecturer at national and international conferences on the topic of ethical controversies in medical practice and research. In a Forbes article, Ross stated, “I don’t see what benefit we’re giving this child by giving the parent this information. It’s not going to help the child clinically.” She went on to state, “Given that these medicine[s] are not needed for healthy newborns, this is, in a sense, predictive genetic testing.” (Photo copyright: University of Chicago Medicine.)

Additionally, some of the drugs included in the MediMap panel are not recommended for use in children, such as the opioid codeine, which leads experts to ask further questions about the usefulness of the test for newborn babies.

And there is the risk that parents and/or care providers could misunderstand or over-interpret the results. The Chief of the Division of Medical Genomics at ITMI, Benjamin Solomon, MD, told Forbes, “When babies are brand new, their livers are physiologically immature.”

In order to avoid over-interpretation, Inova intentionally delays providing the results to pediatricians and parents. Solomon says, “We don’t want there to be any confusion.” The team at ITMI is working to educate pediatricians in the area about the test, and Solomon adds, “I think we are all going to have to work very hard.”

What Could Free Pharmacogenomic Testing Mean for Medical Laboratories

Inova’s willingness to offer a free pharmacogenomic test to every newborn as part of its delivery services is a sign that the cost of sequencing has reached a point where the economics allow Inova’s administrators to make this a free medical laboratory test to patients. Another significant point is that this genetic test is part of the service bundle the hospital is providing when it is time for a mother to deliver. This could be an early market sign that hospitals will see value in including specific medical laboratory tests in the different clinical service that they offer to patients that are offered with a bundled price.

Should MediMap prove to be of value to new parents—and therefore useful as a marketing tool for Inova hospital—it can be expected that other hospitals will follow suit and offer pharmacogenomics testing to newborns as part of a standard package of care. Although Inova developed MediMap in-house, other hospitals may choose to use tests from reference labs.

Whether or not the MediMap panel turns out to be the type of test that pediatricians and parents find helpful, there are other types of genomic tests that parents may want for their newborns. Regardless of the test offered, if parents are motivated to choose a hospital based on the fact that a free genetic test is included as standard care for newborns, clinical laboratories are in a position to provide those tests.

—Dava Stewart

Related Information:

The Case Against Designer Babies 

Extreme Measures

Genetic Discrimination

The Great DNA Debate: The Case For and Against Genetic Testing 

Consumers Aren’t Wild About Genetic Testing—Nor Are Doctors 

One Hospital’s Unusual Freebie for Newborns: Genetic Testing To See How Well They Metabolize Drugs

Technical Report: Ethical and Policy Issues in Genetic Testing and Screening of Children