NEW YORK – Tesis Biosciences is preparing to launch a direct-to-consumer (DTC) pharmacogenetics panel of more than 1,200 genes to help individual consumers understand their own possible drug interactions and to help their physicians make treatment decisions.
The as-yet-unnamed assay encompasses more than 850,000 single-nucleotide polymorphisms (SNPs) and is designed to predict how an individual might react to thousands of drugs across more than 30 drug classifications.
"We want to have a comprehensive, once-and-done test that allows consumers in general to have a good idea of which drugs will work for them," said Divyen Patel, chief research officer at Tesis.
Although there is not yet a launch date, Tesis plans to offer the test online, while also seeking inclusion in large pharmacy chains. The company will offer its assay first as a lab-developed test, before seeking marketing approval from the US Food and Drug Administration.
Patel commented that beyond testing for interactions with major drug classes such as statins, the new assay also tests for interactions with common drugs such as Advil and Tylenol.
"And it's not just SNPs," he added. "We're looking at indels, we're looking at copy number variation, and so on, that all contribute to the metabolism of a drug."
Heidi Rehm, chief genomics officer in the Department of Medicine at Massachusetts General Hospital, commented that she could see the potential utility of a one-stop-shop PGx panel from a geneticist's perspective, but wondered at its utility for physicians.
"When I came to Mass General in my role as chief genomics officer," she said, "I specifically asked [physicians]: 'You're ordering this one, or these two pharmacogenetic tests … if it's the same price to order a whole panel, why not order the panel?' And what they routinely said was, 'I don't want the responsibility or the liability to manage all these other results.'"
Lia Boyle, a physician-scientist in a genetics residency at the University of Michigan, largely concurred.
"I do worry it would be overwhelming for physicians," she said, "in part because with a scope that large, it would not shock me if there are contradicting responses. One of the issues with pharmacogenomics right now is just that there's a lot that we know with little certainty."
Similar to Rehm, Boyle does see potential good in a broad PGx panel. She conditioned this, however, on how the results are presented to physicians and on how the test utility is communicated to patients, particularly in the DTC setting.
"You want something the patient can understand," she said, "but a lot of this stuff isn't simple. There's a reason it can take a genetic counselor or a geneticist 30-plus minutes to talk about a single genetic test with a family."
"In general, clinicians want to have more plain language interpretations," said Josh Peterson, a physician and professor of biomedical informatics and medicine at Vanderbilt University Medical Center.
Knowing that someone is a poor metabolizer of a given drug, for instance, may not be enough without accompanying information on whether to consider specific alternative medications or dose modifications, he explained.
Addressing those issues, Patel said that key strengths of Tesis' panel came in the way that the company is able to consolidate data and simplify the results.
With over 1,500 PGx-related publications and six public databases, he said, "our proprietary 'thing' comes in the way we consolidate those databases and then have a reporting mechanism that pulls out the relevant pieces of data to compose a report that is easy for a physician to be able to understand."
Patel also noted that the array contains only "extremely well-documented" SNPs and that supporting literature will be listed in the report's appendices. The company also offers consulting services to help users understand their results.
Tesis' proposed PGx test appears larger and more comprehensive than any other currently on the market. Similar tests from companies such as Invitae, Myriad Genetics, Tempus, and Diatech Pharmacogenetics focus on narrower sets of disease indications with fewer genes per assay.
Kristine Ashcraft, medical affairs director for pharmacogenomics at Invitae, commented that while a comprehensive approach to assay design is a good way to gather additional data and information to better inform more personalized prescribing, a more focused approach that includes actionable genes and variants of known impact might make more sense in a clinical setting.
Ashcraft said that Invitae's PGx Panel comprises 20 established "evidence genes" and 18 "developing evidence genes," and that ordering physicians have the option to remove any genes that are not of interest.
"We do not recommend any drug or dose changes for the developing evidence genes but store the information discreetly in our clinical decision support tool, YouScript," she said, "so guidance can be provided without the need for retesting if and when the evidence evolves."
Invitae also offers a 15-gene mental health PGx panel, and Ashcraft commented that United Healthcare only covers up to that number of genes.
Tesis' PGx test begins with a cheek swab and can be run and analyzed in approximately three days. The assay runs on Thermo Fisher Scientific's Precision Medicine Diversity Array.
While it remains too early to provide an estimated cost for the assay, or whether it will be reimbursed, Patel said that the company is targeting an affordable price point, "just in the event that the insurance companies don't want to play ball."
Ashcraft noted that with respect to coverage, she sees a need for more private payors to update PGx coverage policies to better reflect current evidence, provide more equitable access, and align with Medicare coverage. She is currently gathering signatures for a letter to multiple payors to request a meeting to discuss the topic.
"Study after study," she said, validates a comprehensive PGx testing approach in reducing both adverse drug events and healthcare spending.
Patel said that Tesis plans to initially launch the assay in North America, but that the company plans to seek worldwide distribution and is already talking to other companies involved in that process.
Additionally, Tesis is recruiting professional athletes such as football players, as well as military personnel into a study of a microRNA-based test of biomarkers for mild traumatic brain injury, which the company had proposed last year, following its acquisition of genomic profiling and molecular diagnostic services company Genome Explorations.