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Interpace Diagnostics Group Inc. (IDXG)

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Last Post: 4/26/2017 4:24:29 PM - Followers: 78 - Board type: Free - Posts Today: 0

NASDAQ CM | IDXG (Common Stock)


Corporate Headquarters
Interpace Diagnostics
Morris Corporate Center 1, Building A
300 Interpace Parkway
Parsippany, NJ 07054

Share Structure:

Authorized Shares: 100,000,000 shares

Outstanding shares: 5,000,000 shares

Short interest:
64% of Float


John P. Dugan: 4,869,878 common shares
other insiders: approx 2,672,149 shares collectively
total insiders: 7,542,027 shares

Institutional Ownership: 30.6% (5.5 mil shares)
largest institutional holder:
Heartland Advisors: 2,994,313

Publically traded float: 10,620,644 shares

if including institutional holders, Float = 5,120,644

Investment Highlights:

Interpace Diagnostics (IDX) was formerly part of PDI that had both IDX and Commercial Services (CSO) businesses. PDI was renamed Interpace Diagnostics Group after the sale of CSO in December 2015
•Focused on developing and marketing molecular based diagnostic tests in high value precision pre-cancerous test markets
•Three proprietary cancer molecular tests on the market in GI and Endocrine
•PancraGenTM–The new standard of pancreatic cyst diagnostics
•ThyGenXTMand ThyraMIRTM-Next-Gen sequencing oncogene panel and miRNAclassifier in combination to improve risk classification of Thyroid nodules
•Two state of the art CLIA-certified labs
•Additional pipeline tests under development including BarreGenTMfor Barrett’s Esophagus, an esophageal cancer risk classifier
•Addressable potential market opportunity of $2.7 billion with all four tests
•Revenue of approximately $10 million in 2015, supported by IDX sales forces
•Focus for 2016: Grow recently launched ThyGenX/ThyraMIRtests and expand PancraGenmarket penetration

Key Milestones:
AUGUST2014:Acquired ThyroidAssetsfrom Asuragen
OCTOBER2014: Acquired RedPathInc., GI assetsand CLIA lab
DECEMBER2014: Launched ThyGenX™NextGen Sequencing Thyroid Cancer Test
FEBRUARY2015: Published landmark study on PancraGen™in Endoscopy
APRIL2015: Launched ThyraMIR™microRNA Gene Expression Thyroid Cancer Test
MAY2015: Published the major clinical validation study in JCEM for combining ThyGenXand ThyraMIRin a single testing service
MAY2015: Published BarreGen™BASE study on Barrett’s Esophagus cancer risk progression in AJG
AUGUST2015: Covered lives for Interpace Diagnostics products exceeded 100 million for all tests combined
OCTOBER2015: Data presented at ACG demonstrate that PancraGen™can improve detection of malignant or highly aggressive pancreatic cysts over current guidelines criteria, and improve patient outcomes in real life management decisions
New data presented at ATA further validates the power of combination testing by ThyGenX™and ThyraMIR™, improving the preoperative diagnosis of thyroid nodules with indeterminate cytology
DECEMBER2015: PDI transformed into Interpace Diagnostics Group through the sale of its CSO business to focus exclusively on molecular diagnostics

High Value Molecular Pre-Cancerous Test Market:

Management Team:

Jack Stover, Interim President and CEO

Mr. Stover has been Chief Executive Officer of Zebec Therapeutics LLC (“Zebec”) since April 2014.  Zebec is the successor to Quadrant Pharmaceuticals LLC, which Mr. Stover co-founded and was President and Director of from September 2013.  Mr. Stover has been a Director and Chairman of the Audit Committee of PDI, Inc., a public company since 2005. From 2009 to February 2012, Mr. Stover served as the executive chairman of Targeted Nano Therapeutics LLC, a privately held biotechnology company focused on targeted delivery of peptides and proteins.  Mr. Stover was also chairman of the audit committee and a member of the board of directors of Arbios Systems Inc. from 2005 to 2008 and a member of the board of directors of Influmedix, Inc. from 2010 to 2011.

From 2004 to 2008, he served as chief executive officer, president and director of Antares Pharma, Inc., a publicly held specialty pharmaceutical company listed on the American Stock Exchange.  Prior to that, Mr. Stover was executive vice president and chief financial officer of Sicor, Inc., a publicly held company which manufactured and marketed injectable pharmaceutical products, and which was acquired by Teva Pharmaceutical Industries.  Prior to that, Mr. Stover was executive vice president and director of a proprietary women’s pharmaceutical company, Gynetics, Inc. (“Gynetics”), and before Gynetics, he was senior vice president and director of B. Braun Medical, Inc., a private global medical device and pharmaceutical company.  For more than five years prior to that, Mr. Stover was a partner with PricewaterhouseCoopers (then Coopers and Lybrand), working in the lifesciences industry division.  Mr. Stover received his B.A. in Accounting from Lehigh University and is a Certified Public Accountant.

Greg Richard, SVP Commercial Services
Greg Richard, Sr. Vice President of PDI, Inc. and SVP of Commercial Services at Interpace Diagnostics, has been in the healthcare business for over 25 years in various industries including managed care, biotech pharmaceuticals, CRO services, and diagnostics. He started his career in sales at Aetna and moved to Genentech as the Director of Managed Care. He transitioned in to the diagnostics industry as the Vice President of Managed Care for Quest Diagnostics and served in this role for 8 years. Greg also led the international clinical trials sales team while at Quest. Following his tenure at Quest, Greg worked for several privately held companies including CRO’s, molecular diagnostics, and anatomic pathology services providers. He also served as the Sr. Vice President of Sales for the Northeast Division of LabCorp. Greg is a certified Six Sigma Green Belt and frequent speaker at healthcare industry conferences such as the G2 Lab Institute and the NextGen Dx Summit.

Syd Finkelstein, Chief Scientific Officer
Dr. Finkelstein is a board certified pathologist specializing in gastrointestinal pathology with extensive experience in molecular diagnostics. He is the Adjunct Professor of Pathology, Drexel University on the faculty of Allegheny General Hospital, Pittsburgh, PA. He serves as Adjunct Professor at Temple University.  He is the founder of RedPath Integrated Pathology, which was acquired by Interpace Diagnostics in 2014.  In this position, Dr. Finkelstein is applying clinical translational research of molecular genetic discoveries to standard surgical pathology practice a goal to which he has dedicated his entire career.   He spent 20 years as a practicing academic surgical pathologist, holding appointments as associate and then full professor at the University of Pittsburgh and at Hahnemann University in Philadelphia. In 1990, he began work on the development of Topographic Genotyping, his patented technology for enhancing polymerase chain reaction amplifiability of minute, microdissected, fixative treated tissue samples. Dr. Finkelstein is a nationally recognized expert in both Gastrointestinal Pathology and Solid Tissue Molecular Pathology.

James E. Early, Interim CFO 
Mr. Early, age 62, previously served as the Interim and subsequently permanent Chief Financial Officer of AbGenomics International Inc., a clinical stage drug development company with a product pipeline in immunology and oncology, from September 2015 to July 2016. Mr. Early also previously served as the Chief Financial Officer of Zebec Therapeutics, LLC from October 2014 to September 2015. In addition, Mr. Early has provided interim chief financial officer and business development services for pharmaceutical, life science and other similar companies as a sole proprietor from August 2009 to December 2013 and through Early Financial Consulting, LLC from January 2014 to the present. Mr. Early is a Certified Public Accountant and has an MBA in Finance and Accounting.
Summary of Early's CFO services:

Strategic Planning
Deal Procurement and Contract Negotiations
Capitalization and Long-Term Financing
Private Equity Modeling
Insurance/Risk Management
IRC 409A and FAS 123R Share Payment/Stock Option Valuation Support
Treasury Management
Internal Audits

Current Marketed Products:

BarreGen is a Molecular diagnostic test to determine the risk of progressing to esophageal cancer in patients with Barrett’s Esophagus

Key Points:

While only about 0.5% of Barrett's esophagus patients will develop esophageal cancer, the 5-year survival rate of esophageal cancer ranges from 4% to 40%.

BarreGen utilizes an assay that assesses loss of heterozygosity and genetic mutations of multiple tumor-suppressor genes.

A longitudinal study shows the BarreGen test had an overall accuracy of 95% in identifying patients who progressed to cancer from those who did not.

PancraGEN® is a unique, DNA-based pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN® is 90% accurate, according to clinical studies, enabling effective risk stratification of patients.  Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.

Long-term follow-up outcomes data of patients (up to 8 years) from the National Pancreatic Cyst Registry supports PancraGEN’s ability to help accurately inform surgery and surveillance decisions of patients.

In a study of the National Pancreatic Cyst Registry, PancraGEN’s recommendation of surveillance was correct in 97% of patients. In fact, PancraGEN diagnoses were more beneficial to overall patient outcomes than sole reliance on International Consensus Guidelines (ICG) criteria.

PancraGEN has been performed on over 25,000 patients with pancreatic cysts, representing a full spectrum of pancreatic cyst patients with diverse clinical and molecular findings.

Medical Publications proving benefits of PancraGen:

ThyGenX® Thyroid Oncogene Panel and ThyraMIR™ Thyroid miRNA Classifier molecular testing that aids in the diagnosis of thyroid nodules by identifying genetic alterations associated with thyroid cancer.  ThyGenX® and ThyraMIR™ combination testing helps to better assess the risk of thyroid nodules being either benign or malignant—and helps reduce unnecessary surgeries.
ThyGenX® is a highly specific oncogene (mutational) panel that assesses the most common genetic alterations across 8 genes associated with papillary carcinoma and follicular carcinoma.
ThyraMIR™ is the first and only miRNA gene expression classifier, and is based on evaluation of expression of 10 miRNAs.

Interpace Diagnostics' ThyGenX™ Thyroid Oncogene Panel molecular diagnostic test is used to improve surgical decision-making for patients with thyroid nodules when standard cytopathology does not provide a clear diagnosis of thyroid cancer. ThyGenX assists physicians in distinguishing between benign and malignant indeterminate thyroid nodules by utilizing state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid malignancies. The ThyGenX panel design is based on the miRInform® test, whose high predictive value has been validated in a recent prospective clinical study involving over 600 patients. Interpace Diagnostics acquired the miRInform test from Asuragen in 2014, and has now enhanced it by upgrading to a NGS platform which provides greater genomic insights and increased panel content.

Better than the competition:
"RE: our Thyroid products, customers continue to be receptive to our combined ThyGenX/ThyraMir assay and we are viewed positively vs. the other products in the market, including Afirma, ThyroSeq2, and Rosetta.  We will also be launching enhancements to our Thyroid offering in the next few weeks." Greg Richard (email 9-21-16)


AccuCEA is our highly accurate CEA method designed specifically for pancreatic cyst fluids and is especially convenient when used with PancraGEN.  Interpace currently performs over 6,000 AccuCEA tests per year for their customers.  CEA is a blood fluid chemistry test that is commonly done as part of an initial screening performed on patients suspected of having pancreatic and other types of cancer.

-The only CEA assay validated for use on small volumes (200uL) of cyst fluid.
-Delivers accurate CEA measurements on pancreatic cyst fluids
-Offers physicians more options – reserve cyst fluid for other diagnostic tests
-Results reported within 1-3 business days

New Version of AccuCEA™ Called "Insights" Provides Physicians Access to 15,000 Patient Database:

The new AccuCEA Insights service provides physicians for whom the Company has already provided first line testing, with additional information on how those results compare to those of other patients in the Company's proprietary database of over 15,000 patients, thus reporting incremental and valuable information on the patient's potential molecular profile and overall risk for developing pancreatic cancer. When the report is delivered to the ordering physician, they have an opportunity to speak with one of the Company's expert molecular pathologists and discuss the potential benefits of conducting a full, molecular pathology review using PancraGen®, the Company's fully integrated product that considers all the results from first line testing, imaging, cytology, and molecular testing and stratifies the patient in one of 4 risk categories.

Upcoming Events/Presentations:

86th Annual Meeting of the American Thyroid Association (ATA) in Denver, Colorado

The first of the two posters entitled "Molecular Analysis of Thyroid Malignancy Using Cytology Smears by Combined THYGENX™ and THYRAMIR™ testing: A Prospective Study" highlights the clinical performance of the combined ThyGenX + ThyraMIR tests when carried out on Fine Needle Aspirate (FNA) material smeared on cytology slides.  

The second poster entitled "The Majority of Non-Diagnostic (Insufficient) Thyroid Nodule Cytology Samples Can Effectively Undergo Molecular (Combined Mutational and MicroRNA Classifier) Analysis Using a Needle Aspiration Approach" demonstrates that Interpace's scientists were able to perform molecular analysis in cases where cytology results were insufficient. 

Set for presentation of posters 50 and 51 on Sept 23:

"DNA Analysis of Pancreatic Cystic Lesions Has Value in Assessing Risk of Future Malignancy"
Oct 19, presented by:

James J. Farrell, MD, Sara Jackson, PhD, Nicole Toney, MPH,
Tamas Gonda, MD, Yale University School of Medicine, New
Haven, CT, Interpace Diagnostics Corporation, Pittsburgh, PA,
New York-Presbyterian/Columbia University Medical Center, New
York, NY

"We are attending the ACG mtg. in Oct. in Las Vegas, where data on our PancraGen test is being presented in a podium presentation by Dr. James Farrell of Yale. " Greg Richard (email 9-21-16)

Preliminary Program (refer to page 41 of pdf)

Lab Locations

Recent News:

09/12/16 Interpace Diagnostics Invited to Present Data at Upcoming American Thyroid Association (ATA) Annual Meeting
08/24/16 Interpace Diagnostics Launches New Product for Pancreatic Cancer Testing
08/16/16 Interpace Diagnostics Reports Record Revenue and Cash Collections for the 2016 Second Quarter
08/04/16 Interpace Diagnostics Announces New York State Approval of Thyroid Test
07/06/16 Interpace Diagnostics Announces Long-Term Outcomes Data for Cohort of 492 Patients
06/01/16 Interpace Diagnostics Announces New Health Economic Data Publications
05/23/16 Interpace Diagnostics Presents New Clinical Utility Data at Digestive Disease Week
05/12/16 Interpace Diagnostics Reports 2016 First Quarter Financial Results and Operational Performance
04/25/16 Interpace Diagnostics Announces Reimbursement Approval By Major National Managed Care Organization
04/18/16 Interpace Diagnostics Announces New Coding by Novitas Solutions for PancraGen™
04/07/16 Interpace Diagnostics Reports Record Cash Collections During March
04/05/16 Interpace Diagnostics Announces Agreement With Galaxy Health Network To Cover All Products
03/30/16 Interpace Diagnostics Group Reports 2015 Financial Results and Recent Accomplishments
03/23/16 Interpace Diagnostics Implements Broad Based Efficiencies and Cost-Cutting Measures Resulting in Significant 2016 Savings
03/01/16 Interpace Diagnostics Announces Agreement with America's Choice Provider Network to Cover All of the Company's Molecular Tests for Thyroid and Pancreatic Cancer
02/17/16 Interpace Diagnostics Receives Medicare Coverage For Its ThyraMIR™ Micro RNA Gene Expression Classifer
01/28/16 PancraGen® Clinical Utility Study Published in Diagnostic Pathology
01/20/16 Interpace Diagnostics Announces New Medicare Local Coverage Determination for Molecular Testing of Pancreatic Cysts
01/12/16 Interpace Diagnostics' New Molecular Test for Thyroid Nodules Now Available Through LabCorp

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Current Price
Bid Ask Day's Range
IDXG News: Amended Annual Report (10-k/a) 04:17 PM
IDXG News: Interpace Diagnostics to Present at RedChip's Global Online Growth Conference 04/24/2017 08:00:00 AM
IDXG News: Interpace Diagnostics Eliminates Long Term Secured Debt 04/20/2017 08:08:00 AM
IDXG News: Current Report Filing (8-k) 04/18/2017 11:20:37 AM
IDXG News: Interpace Announces Coverage of ThyraMIR® with UnitedHealthcare 04/18/2017 08:00:00 AM
News News Alert: Amended Annual Report (10-k/a) 04/28/2017 04:17:38 PM
#2276   Well the conference was today, yep, still nothing viper666 04/26/17 04:24:29 PM
#2275   Is anyone buying this for Q1 earnings? Tdogwm 04/26/17 10:00:30 AM
#2274   I would worry about Q1 results Renegades17 04/21/17 10:08:12 AM
#2273   The Naked Short Scam: Partywagon2014 04/21/17 09:45:07 AM
#2272   Renegades ... Getitgogone 04/20/17 10:13:47 PM
#2271   Hey Getitgogone, Renegades17 04/20/17 09:35:30 PM
#2270   Hey Renegades17 Getitgogone 04/20/17 08:08:15 PM
#2269   Keep in mind they aren't "debt free" they rpablo23 04/20/17 09:38:02 AM
#2268   whoa! stemcell 04/20/17 09:30:46 AM
#2267   I mean there is still money to be rpablo23 04/20/17 08:53:21 AM
#2266   Yup. Wouldn't touch it regardless what they Lone Wolf 04/20/17 08:29:42 AM
#2265   I think people learnt there lesson on the stock1ace1 04/20/17 08:26:32 AM
#2264   Right ...maybe another trade today stock1ace1 04/20/17 08:24:21 AM
#2263   I think they read my post! lol. Lone Wolf 04/20/17 08:14:47 AM
#2262   What's up with the drop? Seems to me Short_moneyC3 04/19/17 04:17:14 PM
#2261   Looking at the chart I noticed 3 of vintagesake 04/19/17 03:34:45 PM
#2260   Make sure you buy back if it drops vintagesake 04/19/17 03:14:35 PM
#2259   Bailed out. Just sold 10K shares of IDXG zerosum88 04/19/17 02:46:54 PM
#2258   Yep,just checked, on the failed to deliver list vintagesake 04/19/17 02:36:55 PM
#2257   The game is stacked against retail...this is being vintagesake 04/19/17 02:28:29 PM
#2256   Could head back to 4 jr525 04/19/17 12:27:44 PM
#2255   I'd agree with you but after every single rpablo23 04/19/17 09:56:56 AM
#2254   I do't think the company expected this. They zerosum88 04/19/17 09:54:42 AM
#2253   I just don't understand how this is good rpablo23 04/19/17 09:39:08 AM
#2252   yep, unreal kmony 04/19/17 09:29:38 AM
#2251   Going lower pos stock1ace1 04/19/17 07:41:27 AM
#2250   I agree. The 8k took it down with Chill1 04/18/17 09:54:12 PM
#2249   This should bounce back... news was solid jr525 04/18/17 09:49:16 PM
#2248   Sold for a loss. At least some of no shorts 04/18/17 05:58:22 PM
#2247   U guys still holding?? jr525 04/18/17 05:44:33 PM
#2246   please! he gave that stellar PPS away to stemcell 04/18/17 05:36:57 PM
#2245   Shaking my head as to that decision to Lone Wolf 04/18/17 05:26:19 PM
#2244   Yeah... same here. I believe we see 4s jr525 04/18/17 05:19:19 PM
#2243   i watched my 4k green profit turn to stemcell 04/18/17 05:18:54 PM
#2242   todays HOD will be back very soon....just wish stemcell 04/18/17 05:17:09 PM
#2241   yeah the news was used against us to stemcell 04/18/17 05:04:57 PM
#2240   Huge volume bought above the close all day... jr525 04/18/17 04:52:32 PM
#2239   * * $IDXG Video Chart 04-18-17 * * ClayTrader 04/18/17 04:21:50 PM
#2238   Volume before price I guess jr525 04/18/17 04:07:28 PM
#2237   can't believe closed a penny above my last kmony 04/18/17 04:06:20 PM
#2236   take off all your bids! stemcell 04/18/17 03:55:54 PM
#2235   my god aren't they done yet? Are they stemcell 04/18/17 03:51:21 PM
#2234   This stock is the most manipulated bio...always on vintagesake 04/18/17 03:27:50 PM
#2233   understand why might want to wait and see, kmony 04/18/17 03:03:25 PM
#2232   IDXG IS OUT OF RETAIL HANDS NOW [SMART MONEY] 04/18/17 03:01:16 PM
#2231   Now it's starting to hurt my eyes! Lone Wolf 04/18/17 02:58:47 PM
#2230   I'll let it bounce for now and risk Marketwise 04/18/17 02:55:39 PM
#2229   its starting to ru again! kmony 04/18/17 02:47:39 PM
#2228   Not certain but I think that heavy selling Marketwise 04/18/17 02:45:03 PM
#2227   Didn't it tank initially because someone dumped a rpablo23 04/18/17 02:31:56 PM