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True Health Diagnostics Expanding Menu of Tests as It Aims to Win Over Physicians


NEW YORK (GenomeWeb) – True Health Diagnostics plans to more than double the size of its menu in the coming year, and the reference lab aims to differentiate itself from competitors by providing reports that are easier for physicians and patients to read.

The diagnostics lab is headquartered in Frisco, Texas and part of the True Health integrated lab and healthcare services company. It was founded in 2014 on the principle that "a personal touch has the power to reshape a patient's entire healthcare experience," CEO and Founder Chris Grottenthaler said in a recent interview.

"Traditional lab results are often impersonal and difficult to interpret, even for physicians," he said, and this perceived gap in the market has led to firm to focus on providing easy-to-understand information.

True Health launched two new tests recently — a lab-developed hereditary cancer test called genTrue and a respiratory pathogen panel test on BioMérieux subsidiary BioFire's high-throughput Torch system — and the firm has plans to build up its menu with more lab-developed and commercial assays.

The company initially started in the cardiovascular space, but now offers a wide range of testing, performing millions of assays annually, Gary Smith, True Health Diagnostic's COO said. In addition to the lab in Frisco it runs a satellite lab in Richmond, Virginia, acquired in 2015 as part of its $37.1 million bid for the assets of Health Diagnostic Laboratory. The company’s revenues have been growing, Smith said, but declined to disclose specific revenue details.

"We currently offer a test menu of about 140 tests, but we are in the process of adding several hundred more to our menu over the next few months," Cera Therrian, the firm's VP of marketing and communications, noted.

True Health Diagnostics provides services similar to companies like LabCorp and Quest Diagnostics, she said. "Where we're different is really the focus on the patient experience," Therrian said. This includes lab reports that are written in clear, user-friendly terms and have proprietary color coding to make them easier to read. It also includes ensuring patients have access to reports, since oftentimes in the testing industry there is "a disconnect where a patient goes in and provides their sample and then may or may not receive their report," Therrien added.

New tests on the market

The firm's genTrue test panel uses blood or saliva and detects 26 targets focused on actionable genes, Wen Bo Xu, the company's senior director of medical genetics, said in the interview. These 26 gene include ones implicated in colorectal, breast, ovarian, uterine, gastric and pancreatic cancers, as well as melanoma.

Because the firm uses Qiagen's QIAseq targeted DNA kits in its lab-developed genTrue test, however, there are actually 143 potential gene targets available in the assay, Smith noted.

The firm can suggest the important targets to physicians based on a patient's clinical presentation and history, but a physician can also choose individual genes for whatever disease state he or she is concerned about in regards the patient, Smith said. Therrien also noted that a very thorough risk assessment and family history is a key part of the genTrue test.

The Qiagen kits have molecular barcodes, "so it gives us a little bit of an advantage over non-barcoded primer enrichment strategies," he added.

Following library prep, the genTrue test involves sequencing using Illumina's NextSeq 500 sequencer. Subsequent analysis of the results is done with an in-house bioinformatics pipeline to call SNPs, indels, and CNVs. The firm has also validated CNV detection with the same platform, so it can simultaneously detect CNVs along with SNVs, Xu added.

Customers for the genTrue test, which launched in April 2017, include primary care physicians and OB/Gyn doctors ordering tests to determine inherited cancer risks in patients with a personal or family history of cancer.

True Health had a base of several thousand primary care physician customers when it launched the test, Therrien said, and offered it to those customers initially. It also has an internal specialty sales force of experts in the hereditary cancer space who are expanding the client base.  

"The market reception has been positive," she said, particularly because the test provides patient insights into his or her own health and potential risks, and the firm focuses on delivering an actionable report that provides information to enable both the physician and patient to take the next steps.

From the technical side, the test is very uniform in terms of coverage and read depth, with the latter being superior to others on the market, Xu claimed. The Qiagen kits enable this in part by using a single-primer extension step. "We have an average read depth of about 400 to 500," he said.

The firm has not publicly presented any data on the genTrue test yet, but is expecting to publish on its bioinformatics pipeline soon.

The cost of the test is competitive with others in the space, Smith said, adding that its positive market reception so far suggests it is not cost-prohibitive.

Smith said the firm is being reimbursed to date in the range in which it had expected, though he declined to provide those numbers.

For the respiratory test, True Health chose BioFire's FilmArray Respiratory Panel on the Torch system because it is "the most comprehensive IVD panel out there," Paul Hetterich, the company's molecular genetics lab manager said in an interview. "That was one of the major deciders for us," he said. A streamlined and efficient workflow was another important factor leading True Health to select the BioFire system over competing technologies.

True Health has a turnaround time of less than 8 hours for the respiratory panel, Therrien said, making it "one of the fastest laboratories providing this service today."

The new assays in its upcoming menu expansion will include many molecular tests, such as a soon-to-launch LDT carrier screening test, as well as infectious disease, allergy, cognitive health, and toxicology tests.

Ease of interpretation for these diagnostic results will also be very important for primary care and OB/Gyn customers, Smith said. "Those people don't always have the opportunity or the time to go in-depth on some of these tests," he said.

True Health Diagnostics is currently "on a very rapid menu expansion path," Smith said, and is planning to add more than 250 new tests in the coming year. The company intends to maintain at least a few different vendor partnerships going forward, but looks to have fewer partners overall, rather than more.

True Health Diagnostics, though, does not have plans to form any exclusive partnerships as it brings on new tests. "We evaluate all of the products on the market and chose the ones that fit our needs the best, not only from an accuracy and test menu breadth standpoint, but also economically," Smith said.

However, he added that, like other labs, True Health does try to focus on a few key, strategic vendors to better leverage its buying power, and a vendor's breadth of menu is important in guiding the process. "You wouldn't want to narrow your vendor base to a few strategic partners that only offer 10 tests," Smith said, "You'd rather have them offer 500 that you could choose from."