Interpace Diagnostics
Reinforcing Molecular Diagnosis with Informatics Data

Molecular diagnostics has taken the oncology universe by storm, enabling physicians to identify indicative risk factors and preemptively detect cancer more efficiently and accurately. In addition to risk stratification, the use of DNA based techniques also significantly help in monitoring disease progression and enables better decision making related to treatment suitable for an individual patient based on their own unique genetic profile. Having employed molecular diagnostic methods for pancreatic and thyroid cancer for over a decade, and backed by a robust informatics database, Interpace Diagnostics delivers cutting-edge and robust mutational analysis that helps in patient risk-stratification for thyroid, pancreatic, and other types of cancers enabling physicians to make better and more informed treatment decisions. The company’s data is used to differentiate between malignant and benign tumors when traditional cytology is indeterminate. Greg Richard, Chief Commercial Officer at Interpace Diagnostics says, “The company’s database contains data from more than 45,000 patients who have been tested with the company’s current products. The database is regularly updating as new patient results are uploaded along with numerous other data elements that can be used for various applications, including population and disease management, companion diagnostics and others. The company currently has four commercialized molecular tests—PancraGEN for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts and solid lesions; ThyGenX for the diagnosis of thyroid cancer from indeterminate thyroid nodules utilizing a Next-Generation sequencing assay; ThyraMIR for the diagnosis of thyroid cancer from indeterminate thyroid nodules utilizing a proprietary miRNA based classifier; and RespriDx for differentiating between metastases and new primary lung tumors.

PancraGEN can help physicians gather a complete understanding of the various aspects of risk associated with pancreatic cysts and determine whether a subject has a high or low risk of developing pancreatic cancer, a disease with a significant mortality rate. The company possesses a large data repository of results from thousands of pancreatic cyst cases, enabling the company to effectively differentiate a cyst and stratify it into one of four different test result categories as per the likelihood of progression of cancer. These test results are classified as benign, aggressive, statistically indolent and statistically high risk. The assessment on these reports provides a physician with insights to determine the best course of action; traditionally that includes a choice between ongoing surveillance of the cyst or invasive and costly surgery. The informatics potential of this data is significant as it represents patients from a wide range of geographic, demographic, and socioeconomic groups.

In diagnosing thyroid cancer, Interpace Diagnostics’ ThyGenX and ThyraMIR tests are deemed reliable by a multitude of endocrinologists. The ThyGenX test can be done on and patient with an indeterminate cytology result; a positive ThyGenX result signifies the likely presence of thyroid cancer and the patient is recommended to undergo a thyroidectomy. The ThyraMIR test is performed as a reflex to a negative ThyGenX test result. A positive ThyraMIR result could indicate either surgery or ongoing surveillance is warranted. The combination of both tests improves risk stratification and surgical decision-making when standard cytopathology does not provide a definite diagnosis for the presence of cancer. It has also demonstrated superior clinical performance over other tests in the market from the standpoint of positive and negative predictive value.

Gaining traction among some of the world’s largest healthcare entities, Interpace Diagnostics’ tests are being rapidly incorporated by physicians around the world. LabCorp, a leader in healthcare diagnostics, offers Interpace Diagnostics’ molecular tests, ThyGenX and ThyraMIR, to their customers, providing enhanced options for the diagnosis of thyroid cancer in patients with indeterminate thyroid nodules. Like the company’s efforts in Pancreactic Cancer, the company has performed over 15,000 molecular tests for thyroid nodules, enlarging its database to accumulate sufficient insights to form the basis of an informatics opportunity for both the company and other organizations with an interest in this area.

Interpace Diagnostics plans to move forward with a unique approach to innovation within their existing products and creating a new market for them. The company is looking forward to growing its recently launched RespriDX product for lung cancer diagnosis and is also planning to launch its new product, BarreGEN for testing Barrett’s Esophagus patients at risk for progression to esophageal cancer. “In addition, we routinely consider synergistic opportunities in the core markets we currently service, i.e. GI, Endocrine, and Lung Cancer. These could take the form of partnerships, acquisitions, in-licensing of technologies, or other arrangements, said Richard. Also, going forward, it will be increasingly important that the data generated from our existing and new technologies bring value to both the company and other organizations that find value in the substantial insights it holds,” concludes Richard.