FDA cautions patients to not use data gained from the DTC test to make healthcare decisions on their own
Free Webinar: Pharmacogenomics: Leveraging Capacity to Expand Your Molecular Laboratory Capabilities
PRESS RELEASE FOR IMMEDIATE RELEASE THE DARK REPORT21806 Briarcliff Dr.Spicewood, TX 78669512-264-7103 o512-264-0969 f Media Contact: Bill Sinagrainfo@darkreport.com Free Webinar: Pharmacogenomics: Leveraging Capacity to Expand Your Molecular Laboratory Capabilities AUSTIN, TEXAS (September 29, 2022) – A new, free Dark Daily webinar will help laboratories discover how to expand into pharmacogenomics (PGx) and learn about the importance of genetics and laboratory services in medication...Free Webinar: Pharmacogenomics: Data and Innovation to Deliver Precise and Appropriate Medication Use
Free Webinar: Pharmacogenomics: Data and Innovation to Deliver Precise and Appropriate Medication Use PRESS RELEASE FOR IMMEDIATE RELEASE THE DARK REPORT21806 Briarcliff Dr.Spicewood, TX 78669512-264-7103 o512-264-0969 f Media Contact: Bill Sinagrainfo@darkreport.com AUSTIN, TEXAS (November 9, 2021) – A new, free webinar by Dark Daily and sponsored by Thermo Fisher Scientific explores how pharmacogenomics can help reduce adverse responses, deliver treatments faster and lower medical costs. On...UnitedHealthcare Announced It Would Cover Certain Pharmacogenomic Tests; However, Experts Hotly Debate the Value of Such Clinical Laboratory Testing
Though more payers are covering laboratory-developed genetic tests for conditions such as depression, the tests remain uncleared by the FDA
Clinical pathologists interested in pharmacogenetics tests for depression and other psychiatric disorders may be interested to learn that UnitedHealthcare (NYSE:UNH) announced in its Network Bulletin a change to its Molecular Pathology Policy and is now covering certain molecular diagnostics. That’s despite the federal Food and Drug Administration (FDA) warning “against the use of many genetic tests with unapproved claims to predict patient response to specific medications.”
In its Safety Communication, the FDA stated healthcare providers and clinical laboratories that “are using, or considering using, a genetic test to predict a patient’s response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication’s effects has not been established.”
In its coverage of the FDA’s warning, The Dark Report, sister publication to Dark Daily, wrote, “Serious concerns are associated with some pharmacogenetic tests and whether physicians have the training and knowledge needed to use this genetic test data appropriately in patient care.”
Should the FDA Even Be Regulating Clinical Laboratory Tests?
Experts note that it is notoriously difficult in some cases for providers to identify which drug or group of drugs is most likely to help a patient with a psychiatric disorder such as depression. Pharmaceuticals that work well for one individual may actually worsen things for someone else.
Nevertheless, the idea that a genetic test could reveal how a psychiatric patient is likely to react to a particular drug is extremely appealing. It could save years of trial and error, which is often terribly disruptive for the patient.
Thus, several molecular diagnostics companies have come up with laboratory-developed tests (LDTs) for pharmacogenomics that they claim can do exactly that. Genomind and Myriad Genetics, as well as others are all marketing LDTs for pharmacogenomics, including Inova Genomics Laboratory, of Falls Church, Va. However, after receiving its own warning letter from the FDA, Inova discontinued sales of its MediMap genetic tests.
Currently, there’s quite a debate about whether these tests should be available, who should take them, and whether they offer any kind of guidance for providers. There’s even a faction that maintains the FDA should not be regulating clinical laboratory tests at all.
Does Evidence of Pharmacogenomics Effectiveness Exist?
Studies regarding the effectiveness of genetic tests for psychiatric disorders have had, at best, mixed results. “Genes determine some of our risk for depression and some of our response to treatment,” wrote Bruce Cohen, MD, PhD, and George Zubenko, MD, PhD, in a Harvard Health Blog post, titled, “Gene Testing to Guide Antidepressant Treatment: Has Its Time Arrived?” The authors go on to say that although the genes that are tested in the panels can have an effect on the levels of the drugs in the patient’s blood, they “generally don’t predict clinical response.”
The authors then discussed the results of a dozen studies that looked into the genetic panels. “Most studies were completely unblinded,” they wrote. “Even with that bias, the use of gene results showed no evidence of effectiveness.”
Advocacy Groups, Payors, and Clinicians Support Pharmacogenomics
Nevertheless, even with the FDA’s warning—and tepid study results— pharmacogenetic testing has its supporters. In large part, that is because identifying the most appropriate medication for any given patient can be incredibly difficult.
“Right now, one of our greatest frustrations is that when [patients] comes in with depression, we have very little idea of what the right treatment for them is,” said Amit Etkin, MD, PhD, Founder and CEO of Alto Neuroscience. Etkin is a professor in the Department of Psychiatry and Behavioral Sciences at Stanford and a member of the Wu Tsai Neuroscience Institute. He authored a study published in Nature that investigated measuring patients’ brainwaves to identify the most appropriate treatment. “Essentially, the medications are chosen by trial and error.”
“You use the science that you currently have,” Reyna Taylor, Vice President of Public Policy and Advocacy, National Council for Behavioral Health, told NPR. She says that doctors should be able to use the tests to inform their choice of medication.
Daniel Mueller, MD, PhD, a psychiatrist and clinical scientist, agrees. Mueller is a professor at the University of Toronto and head of the Pharmacogenetic Research Clinic at the Center for Addiction and Mental Health (CAMH) in Toronto. He told NPR that the pharmacogenomic clinical laboratory tests “are not an alternative intervention. It’s additional information.” He suggests that anyone who can afford the test should take it, because it could help them avoid “the cost of depression and weeks of suffering.”
The decision by UnitedHealthcare to cover genetic tests for depression and other psychiatric disorders could be important. “We expect this to be a tipping point,” Shawn Patrick O’Brien, CEO of Genomind, told NPR, adding that he expects other insurance companies to begin covering the cost of the tests, as well, “because they don’t want to be uncompetitive in the marketplace.”
Historically, there have been few clinical laboratory tests for patients with psychiatric disorders, and while these tests may open a new market in the future, for now, caution is warranted. In addition to the warning from the FDA, there will likely be challenges regarding physician education and curbing fraud.
—Dava Stewart
Related Information:
DNA Tests for Psychiatric Drugs Are Controversial but Some Insurers Are Covering Them
Gene Testing to Guide Antidepressant Treatment: Has Its Time Arrived?
An Electroencephalographic Signature Predicts Antidepressant Response in Major Depression
FDA Authorizes 23andMe to Report Results of Direct-to-Consumer Pharmacogenetics Test to Customers without a Prescription, Bypassing Doctors and Clinical Laboratories
Clinical laboratories continue to be impacted by the growing direct-to-consumer (DTC) testing market, as more walk-in lab customers order at-home tests. Now, the US Food and Drug Administration (FDA) has authorized a DTC test company to provide results of a pharmacogenetic (PGx) test to customers without needing a doctor’s order. This is the first genetic test of its kind to receive such FDA authorization and is in line with the government’s focus on precision medicine.
23andMe gained the authorization through the FDA’s de novo classification process, which the FDA uses to classify new devices that have no existing classification or comparabledevice on the market.
“We’ve continued to innovate through the FDA and pioneer safe, effective pathways for consumers to directly access genetic health information,” said Anne Wojcicki, co-founder and CEO of 23andMe, in a news release. “Pharmacogenetic reports are an important category of information for consumers to get access to, and I believe this authorization opens the door for consumers to work with their health providers to better manage their medications.”
However, some experts caution that informing patients directly on how they metabolize medications based on genetic testing could encourage them to bypass physicians and medical laboratories in the decision-making process.
In a safety communication, the FDA alerted patients and healthcare providers that “claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the FDA and may not have the scientific or clinical evidence to support this use for most medications. Changing drug treatment based on the results from such a genetic test could lead to inappropriate treatment decisions and potentially serious health consequences for the patient.”
PGx Supports Precision Medicine
Pharmacogenetics (PGx) is the study of how genetic differences among individuals cause varied responses to certain drugs. Demand for PGx testing has increased exponentially as it becomes more valuable to consumers. It could provide a path to precision medicine treatment plans based on each patient’s genetic traits. And help determine which drug therapies and dosages may be optimal and which medicines should be avoided.
“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their healthcare providers,” Stenzel told FierceBiotech. “We know that consumers are increasingly interested in genetic information to help make decisions about their healthcare.”
The genes and their variants examined in the 23andMe PGx test are:
- CYP2C19 *2, *3, *17;
- CYP2C9 *2, *3, *5, *6, rs7089580;
- CYP3A5 *3;
- UGT1A1 *6, *28;
- DPYD *2A, rs67376798;
- TPMT *2, *3C;
- SLCO1B1 *5; and,
- CYP2D6 *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *20, *29, *35, *40, *41.
Hospitals Bring PGx Testing to Primary Care
Innovative hospital and health networks also are starting to make PGx tests available in primary care settings.
Sanford Imagenetics, part of the Sanford Health system, has produced a $49 laboratory-developed test (LDT) for genetic screening known as the Sanford Chip to help physicians select the most advantageous therapies for their patients. It uses a small amount of blood to identify patients’ risk for certain genetic diseases and determine which medications would be best for them.
Sanford Health, headquartered in Sioux Falls, SD, is one of the largest health systems in the US with 44 hospitals, 1,400 physicians, and more than 200 senior care locations in 26 states and nine countries.
Geisinger Health, headquartered in Danville, PA, has initiated a pilot project based on PGx testing. The genetic sequencing data from 2,500 patients will be reviewed to determine if they are taking the best medication for their health conditions. Patients in need of changes to their prescriptions will be contacted by Geisinger pharmacists for recommendations.
As consumer demand for PGx testing increases, DTC customers will likely continue seeking new information about their genome. Clinical laboratories could play a role in interpreting that data and assisting pathologists and other healthcare providers determine the best drug therapies for optimal health outcomes.
—JP Schlingman
Related Information:
FDA Clears 23andMe’s DTC Drug Metabolism Test
FDA Clears the First Consumer Genetic Test for How Well Your Medications May Work—with Caveats
23andMe Granted the First and Only FDA Authorization for Direct-to-Consumer Pharmacogenetic Reports