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Interpace Diagnostics Group Inc. (IDXG)

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Last Post: 12/1/2016 6:32:05 PM - Followers: 16 - Board type: Free - Posts Today: 0

 

NASDAQ CM | IDXG (Common Stock)


Interpace Diagnostics Group, Inc., formerly PDI, Inc. is a molecular diagnostics development and commercialization company.

Corporate Headquarters

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

Share Structure:

Authorized Shares: 100,000,000 shares

Outstanding shares: 18,162,671  shares (as of Aug 5, 2016) (hasn't changed since early 2016)

Current Book Value: $0.339 / share

Projected 2016 Revenue per share: on track for .61~.80/share (based on Q1/Q2 reports)

Short interest:

Ownership:

insiders:
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.

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.

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



ACG 2016 Annual Scientific Meeting Oct 14-19 in Las Vegas
    

"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

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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IDXG
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IDXG News: Current Report Filing (8-k) 11/29/2016 05:01:10 PM
IDXG News: Current Report Filing (8-k) 11/18/2016 12:15:50 PM
IDXG News: Interpace Diagnostics Reports Third Quarter 2016 Results of Operations 11/18/2016 10:43:00 AM
IDXG News: Quarterly Report (10-q) 11/17/2016 05:22:06 PM
IDXG News: Amended Statement of Ownership (sc 13g/a) 11/08/2016 10:40:37 AM
PostSubject
#125   How low will this go? any one? marina22 12/01/16 06:32:05 PM
#124   lots of buyers been waiting the right sign ash111 11/30/16 11:30:48 AM
#123   nasty dip, glad i didnt buy other day IN The Mouth Of Madness 11/30/16 11:27:18 AM
#122   IDXG will strat to shoot up after the ash111 11/30/16 11:03:35 AM
#121   Recent Business Updates Include:     ? Evidence supporting Interpace Diagnos ash111 11/30/16 10:28:07 AM
#120   due IDXG Beats twice,Q2+Q3,cap was really a joke ash111 11/30/16 09:40:19 AM
#119   no onle saw the big buys like 28,000 NEXT 11/30/16 01:03:40 AM
#118   Will this pos go back to .o7? marina22 11/29/16 09:43:49 PM
#117   Which MJ tickers are good to get into? marina22 11/29/16 08:02:32 PM
#116   Why did it go up in the first jonsmile 11/29/16 05:41:02 PM
#115   glad i only have 19 shares lol mikekrane 11/29/16 04:02:53 PM
#114   Any upcoming catalyst to move the stock?? Tia omri 11/29/16 01:25:08 PM
#113   wish i could buy IN The Mouth Of Madness 11/28/16 02:45:23 PM
#112   they have until jan 3 2017 IN The Mouth Of Madness 11/28/16 01:28:31 PM
#111   Lol not much supply put there clearly. I've The Claw 11/28/16 01:14:32 PM
#110   I'm in got my partial of 19 shares mikekrane 11/28/16 10:56:33 AM
#109   I'm in got my partial of 19 shares mikekrane 11/28/16 10:56:33 AM
#108   Lol, gotcha and we may see a touch The Claw 11/28/16 09:50:55 AM
#107   I understand ... just saying IF they did Getitgogone 11/28/16 09:48:25 AM
#106   See my previous post regarding the RS, it The Claw 11/28/16 09:45:29 AM
#105   IDXG .35 ash111 11/28/16 09:32:23 AM
#104   You've got a low float and low O/S Getitgogone 11/28/16 09:14:37 AM
#103   My guess is the good quarterly report triggered UP Trend 11/28/16 08:52:16 AM
#102   More buyers than sellers. Oh... 20 pct Magic Stock 11/27/16 10:00:15 PM
#101   Please let me know why idxg is up legalizeMJ 11/27/16 08:57:32 PM
#100   kicking myself ugh IN The Mouth Of Madness 11/25/16 04:22:20 PM
#99   * * $IDXG Video Chart 11-25-16 * * ClayTrader 11/25/16 01:20:24 PM
#98   I all think float is locket benyam 11/25/16 01:11:59 PM
#97   IDXG .30 A/H, Kept a half. been holding ash111 11/25/16 01:08:42 PM
#96   Not sure, but one site promotion started 11/22...worked Full Contact Yoga 11/25/16 12:26:19 PM
#94   all out as second exit and top in TrendTrade2016 11/25/16 11:35:49 AM
#93   IDXG, $0.27, good run. Bought tons at $0.08-0.09 hondaboost 11/25/16 11:19:44 AM
#92   Bammmmmmm ash111 11/25/16 11:12:09 AM
#91   Wow, what's moving this UP Trend 11/25/16 10:56:02 AM
#90   22 break now 29. next!! TrendTrade2016 11/25/16 10:54:50 AM
#89   IDXG bullish 0.1624 stocktrademan 11/25/16 10:53:53 AM
#88   Then .29 would be the top TrendTrade2016 11/25/16 10:51:10 AM
#87   need the 22 break on this attempt TrendTrade2016 11/25/16 10:50:37 AM
#86   okay back in..silly goose!! TrendTrade2016 11/25/16 10:46:54 AM
#85   all out...target of 16c. stick to the plan!! TrendTrade2016 11/25/16 10:16:18 AM
#84   Nice continuation...shedding some here !! TrendTrade2016 11/25/16 10:08:26 AM
#83   * * $IDXG Video Chart 11-23-16 * * ClayTrader 11/23/16 05:19:29 PM
#82   Solid move today, still going A.H ash111 11/23/16 04:37:10 PM
#81   Seen it happen of times, none of them The Claw 11/23/16 02:42:28 PM
#80   this stock is not worth a dollar. they TrendTrade2016 11/23/16 01:33:19 PM
#79   They Don't Have to RS, See below. Also The Claw 11/23/16 01:28:32 PM
#78   Also do you have a link to the The Claw 11/23/16 12:57:56 PM
#77   I never hold any of these pigs long The Claw 11/23/16 12:48:53 PM
#76   Must Read DD !!!! zino 11/23/16 11:03:12 AM
#75   that's huge DD here...nice biotech !!!! zino 11/23/16 11:03:01 AM
PostSubject