Skip to main content
Premium Trial:

Request an Annual Quote

Health Diagnostic Laboratory Using Purchase of Tethys Assets to Further Develop Diabetes Test

Premium

NEW YORK (GenomeWeb News) – Health Diagnostic Laboratory plans this summer to begin running studies of biomarkers comprising its Diabetes Prevention and Management Panel using clinical samples obtained in its purchase of assets from defunct diagnostics firm Tethys Bioscience.

HDL hopes the studies will provide data on the accuracy of its markers and panel for predicting patient conversion from a healthy state to pre-diabetes, as well as from pre-diabetes to diabetes and to more severe outcomes, Szilard Voros, the company's chief academic officer, told ProteoMonitor.

In November 2013, HDL acquired Tethys' assets including biomarker, methodology, and technological patents; patent applications; and trademarks as well as clinical data and patient samples collected as part of both cross-sectional and longitudinal trials.

HDL also acquired Tethys' protein biomarker-based diabetes risk test, PreDx. The company does not currently plan to offer the PreDx test, however, preferring instead to focus on its own existing diabetes products. HDL did not disclose what it paid for the Tethys assets.

Founded in 2002, Tethys shut down late last year after failing in April to win reimbursement from Medicare contractor CGS Administrators for its PreDx test. In the April 2013 ruling, CGS said it had determined there was "insufficient evidence to support the required clinical utility" for the PreDx test as an established Medicare benefit category.

The company launched the original PreDx test in 2009, following up in 2013 with a finger stick-based version of the test. Combining seven different serum markers, the assay was intended to predict a patient's risk of developing type 2 diabetes within the next five years. Patients were scored using a scale from 1 to 10, with 1 representing the lowest risk and 10 the highest. While the company processed more than 175,000 tests, it struggled with obtaining coverage for the test, as demonstrated by the CGS decision.

Tethys investors began shopping the company's assets in the wake of this ruling. Since its launch, the firm had raised more than $100 million in funding from parties including Intel Capital, Mohr Davidow Ventures, Kleiner Perkins Caufield & Byers, Aeris Capital, Wasatch Advisors, DAG Ventures, Greenspring Associates, Top Tier Capital Partners, and Sears Capital Management.

HDL, which focuses primarily on tests related to cardiovascular health and diabetes, said that it plans to continue work on certain research and business efforts begun at Tethys. In addition to PreDx, Tethys was pursuing products for determining risk for first-time heart attack, osteoporotic fracture, and other cardiometabolic diseases.

Voros noted, however, that HDL was primarily interested in Tethys' clinical samples, as opposed to its markers.

"We have a very large armamentarium of markers ourselves, and so our interest has been to look at the accuracy of those," he said. "We acquired Tethys' assets because they had blood samples and clinical data from a number of clinical trials."

Voros said that the company has spent the last several months cataloguing these samples and establishing a plan to use them to analyze markers in HDL's DPMP test, and that it aims to begin a study using these samples this summer.

HDL launched sales of the DPMP test around a year ago, offering it as a laboratory-developed test out of its CLIA facility. The panel consists of more than a dozen markers – including protein and lipoprotein markers – that are either proprietary to the company or which it has in-licensed.

The test does not rely on any overarching algorithm to integrate the different marker values, but, rather, the test is evaluated on a marker-by-marker basis. The test is reimbursed on a marker-by-marker basis, as well, Voros said.

"Obviously it is a complicated grid – each marker per payor per territory – but overall [the test has] good coverage," he said.

In addition to his post at HDL, Voros is also the founder and CEO of Global Genomics Group, a discovery-focused life sciences firm that he characterized as "the R&D vehicle for HDL at the moment." The two firms, both of which are located in Richmond, Va., have a joint venture under which HDL has the option to commercialize G3 research findings.

Most notably, the two firms are partnering on a 7,500-patient study investigating -omics markers for atherosclerotic cardiovascular disease. The study, which launched in December 2012, finished enrollment earlier this month, enrolling patients at 49 sites across North America, Europe, and Australia.

The proteomics portion of the study will be performed by Caprion Proteomics, which aims to identify blood-based protein markers via mass spec. According to Caprion, the company plans to run a discovery experiment numbering in the hundreds of samples, following that up with validation work using thousands of samples.

Ultimately, the G3 study aims to collect and analyze around 22 trillion patient data points related to CVD.

"The idea is to take a very comprehensive approach to risk stratification," Voros said of HDL's approach to building its marker panels.

"For example, in cardiovascular disease we have a paradigm where the primary abnormality … is the retention of atherogenic lipids and lipoproteins," he said. "That retention then creates an inflammatory response which then leads to vulnerable plaques. And often that happens in the setting of insulin resistance."

"So if that is the paradigm, then we have markers that look at lipids and lipoproteins, we have markers that look at insulin resistance, and markers that look at inflammation, et cetera," he said. "So that is the general idea."

The Scan

Review of Approval Process

Stat News reports the Department for Health and Human Services' Office of the Inspector General is to investigate FDA's approval of Biogen's Alzheimer's disease drug.

Not Quite Right

A new analysis has found hundreds of studies with incorrect nucleotide sequences reported in their methods, according to Nature News.

CRISPR and mRNA Together

Time magazine reports on the use of mRNA to deliver CRISPR machinery.

Nature Papers Present Smartphone Platform for DNA Diagnosis of Malaria, Mouse Lines for Epigenomic Editing

In Nature this week: a low-cost tool to detect infectious diseases like malaria, and more.