NEW YORK – InTeleLabs, a company that operates a network of physicians who review test orders and perform patient consultations for online genetic testing companies, has started offering pharmacogenetic testing to individuals through its website.
Recent regulatory actions from the US Food and Drug Administration have made it an uncertain time to be launching consumer-facing PGx testing services on the market. But InTeleLabs CEO Erik Hennings said the company isn't making unsubstantiated claims and is providing physician consultations and genetic counseling to support patients and limit the risk of harm.
Despite the suggestion in its moniker, InTeleLabs doesn't operate its own CLIA-certified lab but partners with other labs to offer testing. The company also has a network of board-certified, state-licensed physicians whose services are increasingly in demand in a market crowded with online, consumer-facing genetic testing services. Formed in 2017, the company has so far focused largely on the physician network component of its business.
For example, a firm called My Gene Counsel earlier this year launched a pilot program to provide education, genetic counseling, and confirmatory testing to individuals with a personal or family history of cancer who have taken a direct-to-consumer cancer risk test but still have unanswered questions. Within this program, individuals who want confirmation of their DTC test results but don't have a doctor to order it for them can pay InTeleLabs $50 to have a physician in its network order testing from Ambry Genetics.
This summer, InTeleLabs decided to get into the testing side of the consumer genomics business by offering pharmacogenetic testing through a new online service called Elicity. Hennings said the company plans to launch other genetic tests with lab partners in the coming months.
InTeleLab's Elicity service currently offers PGx testing to guide decisions about pain, cardiovascular, and mental health drugs, charging around $500 for each category of testing or $600 for comprehensive testing. The tests are performed by IGenomeDx, a San Antonio, Texas-based lab.
Consumers complete an online questionnaire that is reviewed by a member of InTeleLabs' physician network to determine if testing is appropriate. Once approved, customers receive an at-home sample collection kit, which they mail to the lab for analysis. The test report they receive back from the lab identifies the genetic markers patients harbor and how those markers could influence their ability to respond to a variety of psychiatric, pain, and cardiovascular disease drugs.
Hennings said he believes InTeleLabs has designed the consumer-facing offering responsibly, involving physicians in a way that facilitates test access to consumers who may not be able to get them through more traditional medical channels, while also being able to flag situations when testing may be inappropriate.
InTeleLabs' physician network currently includes 10 board-certified professionals who are licensed in multiple states. Physicians are experienced in counseling patients on PGx testing, and some have relevant experience in pain management and anesthesiology. Network doctors are also involved in designing the health history questionnaire that customers must fill out when ordering testing and those same physicians review the questionnaires when deciding whether to approve test orders.
"The same physician that's ordering the test [is the physician] who's reviewing the results, interpreting the results, and doing the physician consults when the results come back," Hennings said, noting that this way, network doctors can distill the information that they need to determine whether a particular PGx testing is appropriate for a patient to order.
Hennings characterized InTeleLabs’ physicians as conducting a "meaningful review" of customers’ health history questionnaires and said they are free to deny test orders if they have a medical reason to do so. "It's not a rubber stamp," he said. "I know there are companies out there that potentially do that."
The Elicity PGx testing service has only been online for a short time, so there is not much data on the types of customers ordering testing and there haven't been instances where physicians have denied orders. But if physicians deny an order out of concern about the patient's safety, InTeleLabs will cancel the transaction and give the customer a refund.
"Patient safety is a key reason why a test could be denied," Hennings said, for example, if the physician feels that there is a risk that the patient might take action and change medications without talking to their own physician.
Before the PGx results are sent to customers online, they have a consultation with an InTeleLabs physician about the test findings, though the physician doesn't make any treatment or medical recommendations. "Patients are always encouraged to go back to their physician and talk about what changes, if any, need to happen," Hennings said. "We are very clear with patients that they're not to take any actions [independent of their doctors.]"
If patients have specific genetic questions, they are referred to genetic counselors. InTeleLabs has partnered with telehealth firm GeneMatters to provide genetic counseling, though a counseling session is not included in the test price. "Frankly, the percentage of times that a patient wants to have that discussion is very low," Hennings said.
Ellen Matloff, founder of My Gene Counsel, which has used the services of InTeleLabs for its confirmatory genetic testing pilot program, commended InTeleLabs for involving genetic counselors in the testing process and for giving customers the option of getting counseled if they need it. "Their physician network has been willing to partner with telemedicine genetic counselors instead of doing the counseling component themselves," Matloff said. "They've not claimed they are the experts and tried to do it themselves, which is a positive model."
While third-party physician networks are increasingly being used to advance genetic testing access among consumers, it remains a controversial model since the doctor in these scenarios don't really have a relationship with the patient to the extent that they can diagnose a disease or prescribe medications. It's important to recognize the risks with this model and strike a balance in consumer genomics offerings, noted Meagan Farmer, genetic counseling business manager at My Gene Counsel.
"On the one hand, we need to think about other delivery models to increase access," Farmer said. "On the other hand, it's hard not seeing a provider that knows your whole history … The companies operating responsibly try to reduce risk by involving genetic counselors when they can."
The FDA cannot regulate the practice of medicine, and therefore hasn't restricted physician networks from offering their services to consumer genomics firms. However, the agency has expressed concern that physicians are making changes to patients' treatment plans based on drug/gene associations that aren't clinically valid, spurred by the marketing claims made by labs.
The agency issued a safety alert in this regard last year and then warned Inova Health System's genomics laboratory to stop marketing its MediMap pharmacogenetic tests without FDA's approval. As a result, the lab decided to stop offering pharmacogenetic testing altogether.
Roseann Gammal, assistant professor of pharmacy practice at the Massachusetts College of Pharmacy and Health Sciences, supports responsibly increasing access to PGx testing, since the results can have lifelong utility to guide medication selection and dosing. However, she also recognized that a theoretical concern to providing this information through the consumer genomics model is that patients could make changes to their medications based on the PGx results without talking to their doctors, which underscores the importance of patient education.
This is likely the agency's driving concern in stepping up regulation of PGx testing. However, FDA's regulation of this space has also been nuanced and healthcare providers may not fully understand how the agency's actions should guide their use of these tests.
For example, in warning Inova's lab, the agency seems to suggest that labs selling PGx tests without FDA approval can only have indications supported in FDA-approved drug labeling. But there are many instances where expert groups like the Clinical Pharmacogenetics Implementation Consortium (CPIC) recommended changing drugs and dosing based on certain PGx variants, but this same information isn't found in FDA-approved drug labels.
"This has been a source of confusion," said Gammal, who is a member of CPIC. She noted that while FDA labeling is a great source of PGx information that's reliable, CPIC should be recognized as another valid resource in this regard.
"Just because you make a prescribing recommendation that isn't in FDA labeling doesn't mean it's bad medicine. Doctors prescribe medications off label all the time based on expert guidelines and current evidence," noted Gammal, who recently started a PGx clinic at Brigham and Women's Hospital in Boston.
These PGx clinics, usually started by pharmacists, are popping up around the country and can help physicians figure out whether to order confirmatory testing when patients come in with results from consumer genomics firms and where to turn for accurate information on PGx testing. At Gammal's clinic, she considers PGx test results in the context of information from FDA labeling and CPIC guidelines, as well as patients' unique clinical variables, when making treatment recommendations.
Numerous physician surveys have cited physicians’ lack of genomics know-how as a major barrier to the integration of genomics into mainstream healthcare and a risk for medical errors and suboptimal patient care. It's not uncommon to hear stories about how patients brought their reports from consumer testing companies to medical appointments, only to find their doctors are unenthusiastic or dismissive about the test findings. As more people gain access to genetic information through online consumer genomics firms, however, physicians and traditional healthcare institutions are beginning to realize that they can't continue to ignore test reports, which may contain clinically significant findings.
Still, healthcare providers need help in this transition. One of the reasons InTeleLabs partnered with IGenomeDx to provide PGx testing is because of the support the lab provides to physicians, who may not be well versed in the genetics of drug response. IGenomeDx uses Coriell Institute for Medical Research's GeneDose Live, a platform that physicians can use to visualize the PGx test report and explore what the published literature says about the variants identified in their patients, as well as different treatment options based on patients' specific clinical scenarios.
The testing service also makes it clear to patients and physicians that genetic information is not the only factor that can influence drug response. "It's just an opportunity to inform them about one piece of the puzzle," Hennings said, adding that it is then up to the physician to determine whether or not the genetic findings are clinically important.
Hennings, who previously conducted regulatory compliance for drugmakers and labs, said he was not surprised by FDA's regulatory activities regarding PGx testing and claimed that it didn't change the way his company would approach its test offerings. "The way we designed this from the beginning, prior to the letter, was to make sure that we're being careful about our claims," he said.
Healthcare industry professionals on the ground, however, are reporting that FDA's recent actions on PGx testing have created an uncertain regulatory environment for labs in terms of what they can say in test reports and promotional materials. For example, the lab that Gammal's clinic orders PGx testing from has recently decided to only report genotypes and phenotypes in test reports and will no longer mention the drugs that the genotype/phenotype results might impact.
"I've heard other labs are doing something similar, because they're afraid of what happened to Inova and they don't want that to happen to them," she said. "But then, you need an expert to be able to interpret the genotype/phenotype information into treatment recommendations."
Although InTeleLabs does not mention any specific drugs or genes in promotional materials, including on its website, IGenomeDx, the testing lab, does currently list them on its website. IGenomeDx also uses the Coriell Personalized Medicine Collaborative’s process for reporting results, which CPMC has published and which involves a PGx advisory body that reviews FDA labeling, the literature, PGx databases such as the Pharmacogenomics Knowledgebase, and other sources of data to interpret test results and come up with treatment recommendations. While this means that test reports will convey drug-gene associations that may not be in FDA-approved drug labeling, Hennings said that these findings are flagged as informational, while markers backed by FDA-approved labeling are reported as clinically actionable. The report also scores the strength of the evidence on specific drug/gene associations.
"As long as that caveat is there, it's important to educate physicians on the latest science. How they use it is entirely up to them," Hennings said. "If I were a patient, and genetics could potentially play a role in how I metabolize or react to drugs … I'd want to know. I'd want to know with the disclaimers and the limitations of what the information is telling and not telling me, and [I'd want to] have the option of talking to a physician."