DxTerity Diagnostics is transforming genomic research with the introduction of Direct-To-Patient (D2P) Genomic Studies and more frequent genomic monitoring via patient-collected blood samples. By improving the way transcriptome and genome data are collected, DxTerity provides translational research and clinical researchers with broader access to biomarker datasets.
“Our unique process allows us to cost-effectively generate full genome and full transcriptome datasets from a very small amount of genomic material. The real barrier to commercializing new genomic tests is the time and expense of performing clinical studies. We are looking to change this with the introduction of our D2P genomic study services,” explained Jim Healy (COO).
Jim Healy, COO, DxTerity
Traditionally, running a large scale study to develop and validate a promising genomic test requires recruitment of multiple study sites, lengthy contract negotiations, and multiple investigational review boards (IRBs). Healy explained, “And even if a pharma or biotech is able to jump through all those hoops, the size of the patient cohorts and the frequency of patient sampling are still limited by the geographical location and willingness of patients to travel to study sites.”
DxTerity’s D2P service uses a single centralized institutional review board (IRB), nationwide digital recruitment of patient cohorts, and “From Home” sampling of patients to dramatically lower the burden of clinical studies for both the researcher and patient. “With our D2P service, the patient is the site. Patient sampling and monitoring can be performed Anytime, Anywhere, and on Anyone.”
Direct-to-Patient (D2P) Platform
DxTerity’s “direct-to-patient” platform is enabled by a cost-effective, self-administered finger-stick blood collection and nucleic acid stabilization device that can be distributed and returned via USPS mail. No refrigeration is required. This technology allows almost anyone to collect a blood sample, anywhere, and at anytime. The device stabilizes both the RNA and DNA in the blood sample, enabling full genome and full transcriptome profiling. Once the sample has been mailed back, it is analyzed in DxTerity’s CLIA-licensed, CAP-certified genomics laboratory.
“Depending on the study needs, we can perform either complete genomic/transcriptomic analysis or focus on targeted biomarker panels,” said Bob Terbrueggen, PhD (CEO). This enables comprehensive testing that provides unparalleled insights into the condition, as well as robust measurement of disease indicators from minute amounts of blood. Patients in drug trials typically provide blood samples in 2-4 month intervals. “But an added benefit of D2P,” Terbrueggen pointed out, “is the ability of researchers to monitor patients more frequently—post-dose or post-disease flare.” By driving down the cost for accessing participants and collecting samples more frequently from larger cohorts, DxTerity gives researchers a much higher resolution picture of disease activity. “Simply put, getting more samples from more people more frequently will accelerate important precision medicine initiatives.”
Additionally, D2P’s electronic consent (e-Consent), electronic data capture (EDC), and electronic patient-reported outcomes (ePROs) enables a complete platform capable of executing genomic studies with unprecedented speed, scale, and cost savings while providing more data points than ever before.
“A key cost savings is the accelerated timeline for starting and completing genomic studies,” Terbrueggen said. DxTerity’s D2P services platform enables organizations to enroll patients and begin a large scale study in mere months, compared to the one or two years it sometimes takes just to recruit and negotiate with the multiple healthcare facilities needed. Add in the benefits of expanded geographical reach and the lack of patient trips to a blood collection center, and genomic studies can be completed in record time for a fraction of the cost.
Bob Terbrueggen, CEO, DxTerity
DxTerity also provides FDA 21CFR 820 Quality System Regulation (QSR) compliant product development services to pharma and diagnostic partners. “There’s some conflict in the industry between LDTs and FDA-approved tests,” Terbrueggen said. LDTs have evolved from simple, single gene tests for rare conditions, confined to single labs, to complex, multi-variate assays used to diagnose and monitor highly prevalent diseases. With the accuracy and clinical usefulness of many genomic tests being questioned, the FDA is calling for more oversight. A likely result of these debates is the need for more controlled product development and larger scale validation studies.
DxTerity’s D2P platform provides a viable solution for generating the large scale validation datasets needed for third-party reimbursement, and DxTerity’s Product Development Services provide additional resources for meeting the increased regulatory burden. Thanks to a licensing agreement with Thermo Fisher, DxTerity can develop, manufacture, and distribute kitted FDA-cleared diagnostic assays for readout on a large install base of clinical instruments.
“DxTerity’s overarching objective is to bring genomics to everyday care,” Terbrueggen said. “The first step in accomplishing this is facilitating new translational research at large scale with bigger datasets. The next step will be adoption by clinical trials, followed by clinical practitioners in routine healthcare. Genomics has become affordable, and now it’s time for it to also become accessible.”