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Interpace Diagnostics Group Inc. (IDXG)

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Last Post: 10/18/2017 9:18:51 AM - Followers: 89 - Board type: Free - Posts Today: 0

 

NASDAQ CM | IDXG (Common Stock)

http://www.interpacediagnostics.com
http://pdi-inc.com

 

Corporate Headquarters
Interpace Diagnostics
Morris Corporate Center 1, Building A
300 Interpace Parkway
Parsippany, NJ 07054
844-405-9655

Share Structure:

Authorized Shares: 20,000,000 shares
Outstanding shares: 8,788,604 - May 05, 2017

Short interest:
64% of Float

Ownership:

Insiders:
John P. Dugan (Founder) : 4,869,878 common shares
other Insiders: Approx 2,672,149 shares collectively

Total Insider Ownership: 7,542,027 shares
Total Institutional Ownership: 30.6% 5.5 mil shares (6.5 Mil as of June 2017)

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.

https://www.doximity.com/pub/sydney-finkelstein-md?show_more=true#publications


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.

http://www.earlycfo.com/
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
Acquisitions
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.
 

http://www.ascopost.com/News/29620


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:
http://www.interpacediagnostics.com/pancragen/publications/

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™

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.

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:
http://online.liebertpub.com/doi/full/10.1089/thy.2016.29027.abstracts

"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)
http://acgmeetings.gi.org/pdfs/ACG16-Preliminary-Program.pdf


Lab Locations
 

 
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IDXG News: Interpace Diagnostics Presents Important Data at the World Congress of Gastroenterology at American College of Gastroenterolo... 10/23/2017 08:45:00 AM
IDXG News: Interpace Diagnostics Presents New Data from Over 3,400 Patients Tested with ThyGenX®/ThyraMIR® 10/18/2017 08:45:00 AM
IDXG News: Interpace Diagnostics to Present at the Dawson James Securities 3rd Annual Small Cap Growth Stock Conference 10/17/2017 08:30:00 AM
IDXG News: Small Company Offering and Sale of Securities Without Registration (d) 10/16/2017 04:57:19 PM
IDXG News: Current Report Filing (8-k) 10/12/2017 12:36:04 PM
News News Alert: Interpace Diagnostics Presents Important Data at the World Congress of Gastroenterology at American College of Gastroenterolo... 10/23/2017 08:45:00 AM
PostSubject
#2622   Institutional ownership https://fintel.io/so/us/idxg Wise wise_investor 10/18/17 09:18:51 AM
#2621   Are you saying that the company will short compliant777 10/16/17 01:54:01 AM
#2620   That doesn't mean a thing. They can build OhManIDied 10/13/17 06:11:47 PM
#2619   October 12 - 19 restricted period; then shares compliant777 10/13/17 05:12:24 PM
#2618   The dilution is evident, it will bring down ttottip 10/13/17 09:53:22 AM
#2617   Sold at the peak, I'll be back when Dmwcrash 10/11/17 09:45:23 AM
#2616   Great news this morning - signals increased acceptance MaineMan5 10/11/17 09:03:59 AM
#2615   I agree with you to a certain extent, wise_investor 10/09/17 03:34:20 PM
#2614   $1.40-1.45 is the real support here. If it Dmwcrash 10/09/17 11:06:55 AM
#2613   New Molecular Lung Cancer Test MVPdX, already covered apollo1452 10/08/17 01:14:18 AM
#2612   Wall Street experts assign 5 $ price target Chuckx 10/06/17 04:00:34 AM
#2611   Anyone have news on the meeting today? Dmwcrash 10/05/17 05:33:21 PM
#2610   If i had 10k right now, I would wise_investor 10/04/17 02:24:31 PM
#2609   Bollinger bands will narrow, just like they did wise_investor 10/04/17 02:16:33 PM
#2608   So what's the current bear case with IDXG? apollo1452 10/03/17 11:01:18 PM
#2607   Man. Other than DCrash nothing but crickets and ghostrider19 10/02/17 07:26:30 PM
#2606   My advice, hold. Buy more if you want Dmwcrash 10/02/17 01:19:33 PM
#2605   Got it !! Thanks so much DCrash ghostrider19 09/29/17 09:53:19 PM
#2604   Insiders offered a total of 628,000 common shares Dmwcrash 09/29/17 09:45:20 PM
#2603   Check out the chart! The two bullish wedges Dmwcrash 09/29/17 09:39:21 PM
#2602   Hey DCrash. Just stumbled upon this symbol. Can ghostrider19 09/29/17 06:30:49 PM
#2601   Looks like it, now we just need to Dmwcrash 09/29/17 10:12:14 AM
#2600   So this new CEO, is he gonna make Dmwcrash 09/25/17 09:23:11 AM
#2599   Big gap up Monday in the morning! ttottip 09/15/17 03:56:12 PM
#2598   Boomin! Joecanada13 09/15/17 03:52:28 PM
#2597   Hoping for another good day tomorrow drlord10 09/14/17 05:06:42 PM
#2596   Until now! ttottip 09/14/17 11:05:01 AM
#2595   I made wrong calculation:they lost $15,000. ttottip 09/14/17 11:04:14 AM
#2594   The persons or the person who sold this ttottip 09/14/17 11:00:23 AM
#2593   IDXG is here to stay and going higher. ttottip 09/14/17 10:47:59 AM
#2592   I predict over $1.8 the close today. ttottip 09/14/17 10:05:53 AM
#2591   This block @ $1.37 will be eaten soon! ttottip 09/14/17 10:02:46 AM
#2590   Is anyone interested in some dipping sauce? Wise wise_investor 09/13/17 10:04:51 PM
#2589   Lucky they that bought the dip. ttottip 09/13/17 03:37:17 PM
#2588   New director? You've caught my attention Dmwcrash 09/13/17 11:07:01 AM
#2587   Well the price did double... since ot was wise_investor 09/13/17 01:13:31 AM
#2586   You guys have been saying that for some time... BigTony1 09/12/17 02:58:38 PM
#2585   Very interesting! Huge bids means the price is ttottip 09/12/17 12:10:57 PM
#2584   Chart starting to develop for a long term hold ilovestocks85 09/12/17 08:03:25 AM
#2583   IDXG 1.77 PAC 09/11/17 09:39:03 AM
#2582   Based on absolutely nothing It's ok to be Lenard 09/10/17 10:53:26 PM
#2581   No need for dilution, enough money til 2019 horsebfree 09/09/17 10:42:49 AM
#2580   And this dilution will bring the price down ttottip 09/08/17 11:41:48 AM
#2579   In my opinion, there is some kind of ttottip 09/08/17 11:21:49 AM
#2578   What is the presentation about? drlord10 09/06/17 09:02:38 AM
#2577   Presentation at noon. Interested to see what Lone Wolf 09/06/17 08:22:02 AM
#2576   * * $IDXG Video Chart 09-05-17 * * ClayTrader 09/05/17 04:16:45 PM
#2575   Yep, last week Sparky77 09/05/17 03:14:46 PM
#2574   Very strong momo. IDXG crudeoil24 09/05/17 12:13:07 PM
#2573   IDXG 1.6 +17% volume coming in big PAC 09/05/17 10:05:21 AM
PostSubject