2. Forward Looking Statements
2
This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future
financial and operating performance. The company has attempted to identify forward looking statements by terminology including
"believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking
statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about,
among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or
impossible to predict accurately and many of which are beyond our control. These statements also involve known and unknown
risks, uncertainties and other factors that may cause our actual results to be materially different from those expressed or implied
by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, our
ability to adequately finance the business, our ability to restructure our debt and other obligations, the market's acceptance of our
molecular diagnostic tests; our ability to secure additional business and generate higher profit margins through sales of our
molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated
internal rate of return on investments and our ability to maintain our NASDAQ listing.. Additionally, all forward-looking statements
are subject to the risk factors detailed from time to time in our periodic and other filings with the Securities and Exchange
Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 30, 2017, and in
the companyās Form 10-Q filed with the SEC on November 17, 2016. Because of these and other risks, uncertainties and
assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only
as of the date of this Investor Presentation and, except as may be required by law, we undertake no obligation to revise or update
publicly any forward-looking statements for any reason.
3. Our Mission
3
We are a fully integrated ācommercialā
company that provides molecular and
diagnostic tests and pathology services
to evaluate the risk of cancer by
leveraging the latest technology in
personalized medicine for better
informed clinical decisions and
improved patient management.
4. Overview
ļ± NASDAQ listed company
ļ± We are a commercial company with high value molecular
diagnostics
ļ± Dedicated Sales force with expertise in billing &
reimbursement
ļ± We operate 2 CLIA certified, Cap accredited labs
ļ± High-margin oncology diagnosis and prognosis tests
ļ± 4 proprietary offerings in two key verticals (Endo & GI)ā 3
products now covered by Medicare
ļ± High barriers to entry due to reimbursement, complexity of
tests and intellectual know how 4
5. Recent Accomplishments
ļ± Raised over $14 mil. recently
ļ± Converted over $9 million of secured debt into common stock, eliminated key
milestone and royalty costs and all liens are being lifted.
ļ± Added over $11 million to equity since year end
ļ± Revenue growth of 39% YoY
ļ± Significant improvement of over $20 million in cash burn YoY
ļ± All tests are now approved for sale in NY State
ļ± Launched international distribution
ļ± AETNA & UnitedHealth insurance reimbursement for ThyraMIR announced
ļ± Good pipeline opportunity with BarreGEN
5
6. Molecular Diagnostic Market
Drugs
Diagnos cs
Development
Costs
Development
Timelines
Regulatory
Risk
$800M+
$3M
8-10 yrs
1-3 yrs
FDA Review
LDTs
De-risked business model
Versus Drugs, Diagnostics have:
- Lower path-to-market risk than drugs
- Faster time to market than drugs
- Lower regulatory hurdles
*http://www.grandviewresearch.com/industry-analysis/molecular-diagnostics-market
*https://globenewswire.com/news-release/2016/09/13/871416/0/en/
Molecular Dx: A significant revenue potential
- The global molecular diagnostics market size was valued at USD 6.45 billion in 2015.*
- It is expected to witness attractive growth with a CAGR of around 12.0% till 2024.*
- Global molecular diagnostics market is expected to reach over USD 17.9 billion by 2024.^
7. Powered by PathFinderTGĀ®
Our Marketed Molecular Tests
Estimated Current U.S. Market Opportunity
Pancreatic Cysts
$300-370M
Thyroid Nodules
$350M
GastrointestinaI Endocrine
Source: JAMA, 2012; Archives of Internal Medicine 2009
7
8. new U.S. cases
39,590U.S. deaths
Medicare,
35%
Medicare
Advantage,
19%
Commercial,
29%
Client
Billing, 11%
Others,
6%
PancraGen*
*Payer mix % based on claim submissions; May vary by month
PancraGen and Thryoid Tests - Payor Type Mix
8
Medicare,
3%
Medicare
Advantage,
9%
Commercial,
52%
Client
Billing, 30%
Others,
6%
Thyroid
9. Source: Cooper DS et al. Thyroid. 2009;19(11):1167-1214; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Thyroid
Carcinoma. V.1.2014; ATA Guidelines on Thyroid Nodules and Differentiated Thyroid Cancer ā Highlights, Consensus, and Controversies. ICE/ENDO conference;
June 21-24, 2014; Chicago, Illinois.
2014 American Thyroid Association Revised Guidelines
MDx Tests should be considered for suspicion of malignancy or indeterminate.
2013 NCCN Guidelines
Molecular Diagnostics recommended testing on some indeterminate cytologies to minimize
unnecessary surgeries
Guideline Recommendations
9
PancraGenā¢ establishes a new standard for the prognosis and diagnosis of
pancreatic cysts
Current Pancreatic Cysts Guidelines
Sendai guidelines 2012 and ACG guidelines 2007 strongly favor surgical resection because
of the inability of first-line tests to predict biological behavior and aggressiveness.
10. GI Endocrine
Billing & Reimbursement Overview
10
List Price $4,000
Averaged Realized
Revenue
$2,600
Now Billed Under
Molecular Code
81479
Covered Lives +71 million
List Price $1,675 $4,000
Averaged Realized
Revenue
$1,100 $2,000
Now Billed Under
Molecular Code
81445 81479
Covered Lives +200 million +200 million
12. The Third Leading U.S. Cancer Killer
ļ§ 5-year survival rate 7.2%
ļ§ Pancreatic cancer 3% of new cancer cases in US, 7% of deaths of common cancers
Pancreatic Cancer
12
https://seer.cancer.gov/statfacts/more.html
Cervical Ovarian Prostate Breast Pancrea c Colorectal Lung
4,020
14,270
26,120
40,450
41,780
49,190
158,080Number of New US
Cases in 2016:
45,000
__________
Number of US
Deaths in 2016:
41,780
13. PancraGENā¢ (formerly PathfinderTGĀ®)
Imaging Cytology Fluid Analysis
(CEA , Amylase)
Molecular
Diagnostics
Pathologist
Review
ā¢ DNA quantity & quality
ā¢ Oncogene point mutations
(Karas, GNAS)
ā¢ Loss of heterozygosity (LOH)
25 markers measured
ā¢ Detailed quantitative
molecular profiling integrated
with first-line clinical findings
leading to risk assessment
and clear, management
recommendations
PancraGEN ā Integrated Molecular Pathology
34%
8%
52%
6%
CEA above 1000 ng/ul with High EUS
Benign
Statistically Indolent
Statistically Higher Risk
Aggressive
+
Virtual risk assessment using 13,000+ testing & 492 cyst registry pts
13
14. 120,000 Pancreatic Cysts Annually
ā¢ The clinical dilemma:
ā Current guideline tests are biased towards
sending patients to surgery and poorly predict
cancer risk
ļ§ Cyst fluid tested for CEA, amylase, and
cytology (1st line tests)
ā¢ The result:
ā 80% of all surgeries are for benign disease3
ļ§ Unnecessary healthcare costs
ļ§ High morbidity (30%) and mortality (2%)2
associated with these surgeries
ā Pancreatic cancers go undetected
Pancreatic cysts:
2-5%
risk of cancer
increasing with
age1
Pancreatic cysts:
80%
surgeries are
benign
Source: 1Gastroenterology Research and Practice Volume 2012, Article 147465
2Gastroenterology 2015; 148:819-822
3http://www.seenamagowitzfoundation.org/pancreatic-cysts/
14
15. Substantial Improvement Over Guidelines
15
Results published in leading GI journal, Endoscopy
Performance of
all patients (n=492) PancraGEN
ICG
Sendai
Guidelines P-Value
Accuracy 90% 52% N/A
PPV 21%58% <0.0001
NPV 97% 97% 0.88
Sensitivity 83% 91% 0.17
Source: Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts, Endoscopy. 2015 Feb 47(2): 136-46. Epub 2014 Oct
Specificity 91% 46% <0.0001
17. PancraGEN-A New Standard
PancraGEN establishes a new standard for the prognosis and
diagnosis of pancreatic cysts
17
Sendai guidelines 2012 and ACG guidelines
2007 strongly favor surgical resection because
of the inability of first-line tests to predict biological
behavior and aggressiveness.
19. 19
Common clinical problem
~10-18 m
US Adults have nodules
Estimated
525,000
thyroid FNA per year in
US and growing
Thyroid Cancer Incidence*
*American Cancer Society
http://www.cancernetwork.com/thyroid-cancer/thyroid-nodules-when-biopsy
Thyroid Nodules
20. 1. Gharib H, et al. Endoc Pract 2010.
2. Wang CC, et al. Thyroid 2011.
Finalsurgicalpathologydiagnosis3
Non Diagnostic Benign Indeterminate* Malignant
Benign
Malignant
Cytopathology DiagnosisSuspicious for
Malignancy
201. Gharib H, et al. Endoc Pract 2010.
2. Wang CC, et al. Thyroid 2011.
Finalsurgicalpathologydiagnosis3
Non Diagnostic Benign Indeterminate* Malignant
Benign
Malignant
Final Histopathology:
Cytopathology Diagnosis
12%
6%
23%
62% 97%
77%
0%
20%
40%
60%
80%
100%
Suspicious for
Malignancy
* Indeterminate (Follicular Lesion2) includes Atypia of Undetermined Significance (AUS)/Follicular Lesion of Undetermined Significance(FLUS) and
(suspicious for) HĆ¼rthle/Follicular Neoplasm
Clinical Dilemma of Indeterminate
Thyroid Nodules
21. Significant Surgical Risk
ā¢ Large incision in sensitive
area and potential for
significant scarring
21
ā¢ Risk of vocal cord
damage, hoarseness,
paralysis, and at the
extreme, tracheotomy
22. ā¢ The only Dual Platform Thyroid Test available commercially
ā¢ ThyGenXā¢ and ThyraMIRā¢ combination testing can
accurately āRule inā and āRule outā the risk of malignancy
ThyraMIRā¢ measures the expression of 10 microRNAs and, when used in
combination with ThyGenXā¢, yields both high NPV and high PPV
ā¢ Only commercial test that can be performed from FNA and/or
Cytology Slides
ā¢ ThyGenXā¢ and ThyraMIRā¢ combination testing addresses a
unmet clinical need for more actionable information in the
management of indeterminate thyroid nodules
+
22
NGS Sequencing Platform MicroRNA Classifier
ThyGenX / ThyraMIR Thyroid Panel
23. Data Comparison with Market Leader
Labourier et al. Molecular testing for miRNA, mRNA, and DNA on fine
needle aspiration improves the preoperative diagnosis of thyroid nodules
with indeterminate cytology, n=109
Test
performance
[95% CI]
Combined mutation
& miRNA testing
(ThyGenX +
ThyraMIR)
Mutation
testing alone
(ThyGenX)
Gene expression classifier
with mRNA testing
(AfirmaĀ®)
Population
(FNA cytology
results)
AUS/FLUS & FN/SFN AUS/FLUS,
FN/SFN, non-
diagnostic
AUS/FLUS FN/SFN
Sensitivity (%) 89% [73-97] 48% [29-68] 90% [74-98] 90% [68-99]
Specificity (%) 85% [75-92] 89% [72-98] 52% [44-59] 49% [36-62]
PPV (%) 74% [58-86] 81% [54-96] 47% [40-55] 37% [23-52]
NPV (%) 94 %[85-98] 64 %[47-79] 93% [86-97] 94% [79-99]
24. Cancer prevalence: 32%
38% ābenignā
with 93% NPV
62% āsuspiciousā
with 47% PPV
SurgeryFollow
Afirma
Avoidable surgeries: 68% 33%
Indeterminate diagnosis
Combination testing provides accurate molecular reclassification without surgery
ā¢ 85% (6.7-fold) decrease in unnecessary surgeries (from 68% to 10%)
ā¢ 69% (3.3-fold) decrease in unnecessary surgeries relative to Afirma (from 33% to 10%)
ā¢ 65% (1.65-fold) increase in true benign yield relative to Afirma (from 35% to 58%)
ā¢ Pts with benign disease avoid surgery, 75% pts with cancer proceed directly to total thyroidectomy (red)
Surgery
68% benign outcome
Indeterminate diagnosis
61% ābenignā
with 94% NPV
39% āmalignantā
with 74% PPV
Combination testing
SurgeryFollow
10%
Indeterminate diagnosis
24
Yield of Molecular Reclassification
25. ā¢ Combined test performance results in a 94% likelihood that a negative
result is truly benign and a 74% likelihood that a positive result is malignant
(based on a prevalence of 32%)
ā¢ The 74% likelihood of a positive result being malignant is a clinically
significant improvement over the ā50/50ā likelihood of the Afirmaās
suspicious call
ā¢ The benign call rate for ThyGenX/ThyraMIR is superior to AfirmaĀ®āallowing
up to 65% more patients to consider a watchful waiting approach
ThyGenXā¢ / ThyraMIRā¢ Summary
The end result is a 69% decrease in unnecessary surgeries
relative to the Afirma test. (Labourier et al., JCEM 2015)
+
25
29. What is Barrettās Esophagus?
ā¢ Gastroesophageal reflux very common (10-
20% US adults)
ā¢ 6% progress to Barrett's Esophagus
(~3.3 million adults)
ā¢ Barrett's Esophagus precedes esophageal
cancer (EAC) infrequently (1-3%)
ā¢ Ablation (Barrx) has emerged as a treatment
and prevention strategy
ā¢ Current tests cannot predict which patients
will progress to EAC ā a high unmet need for
a molecular diagnostic test
29
30. BarreGEN for Barrettās Esophagus
30
Barrettās is currently diagnosed by pathology
Normal squamous
mucosa
Intestinal
metaplasia (IM)
Low grade
dysplasia (LGD)
High grade
dysplasia (HGD)
Adenocarcinoma
(EAC)
High Risk Disease
Increasing severityIncreasing severity
Increasing Severity
31. How may BarreGEN be useful?
31
Results of BASE study published in Am J. Gastroenterol (AJG)
Performance Characteristic Patient ML ā„1
Sensitivity (%) 96
Specificity (%) 87
Accuracy (%) 90
Odds ratio 147 (p<0.0001)
1. Case-control study N= 69 patients (46 controls and 23 cases).
2. Mutational load (ML) to measure genetic instability (LOH) associated with tumor suppressor genes
3. Based on ML score, BarreGen predicts risk of BE for future progression to cancer
90% accurate at identifying patients with Barrettās Esophagus who will
develop aggressive disease within ~3 years
Source: The presence of genetic mutations at key loci predicts progression to Esophageal Adenocarcinoma in Barrettās Esophahus. Am J. Gastroenterol.
2015 June 110(6): 828-34. Epub 2015 May
AUC = 0.95 (95% CI 0.89ā1.0)
32. How may BarreGEN be useful?
ā¢ Current surveillance methods based on histology are inadequate at
assessing risk of disease progression to HGD/EAC
ā¢ BarreGEN may help differentiate patients a low risk of EAC from high
risk of EAC prior to visible HGD/EAC morphology
ā¢ BarreGEN can allow for more personalized management of Barrettās
patients including:
ā¢ Aid in strategies to prevent cancer (ablation)
ā¢ Avoid unnecessary, expensive ($30k) and recurring ablations
ā¢ Help monitor patients during surveillance
ā¢ Reduce healthcare costs overall
32
33. ļ§ Soft launch initiated in H2 2016
ļ§ Prognostic value in determining cancer progression risk
ļ BASE study Eluri 20151 (n=69)
ļ§ Diagnostic value in detecting true dysplasia (HGD) in BE
ļ Ellsworth 2012 study2 (n=271) and Khara 2014 study3 (n=415)
ļ§ Additional clinical studies required
ļ§ Establish collaborations with Barrettās Center of Excellence
ļ§ Excellent partnering opportunity
1 Eluri et al. Am J Gastroenterology 2015, 110:828-834
2 Ellsworth et al. BMC Gastroenterology 2012, 12:181
3 Khara et al. J. Gastrointestinal Cancer 2014 DOI 10.1007/s12029-013-9570-y
BarreGenā¢ - Multi-stage Introduction
33
34. Select Financial Information
(In US Million)
(In US Million) 2016 Results 2015 Results
Revenue $13.1 $9.4
Gross Margin 49% 27%
Total Operating
Expenses $12 $43
Loss from
Continuing Ops $(7.5) $(31.1)
Cash Balance EoY $.6 $8.3
Recent Capital Raise $14 million
36. Patent Portfolio and Proprietary Attributes
36
Thyroid: 9 patents pending- Seven patents on microRNAs as biological markers for distinguishing
benign from malignant thyroid neoplasm. One patent on microRNAs as diagnostic biomarkers to
distinguish benign from malignant thyroid nodules. One patent on the combination
ThyGenX/ThyraMIR assay to classify thyroid nodules.
Pancreas: 3 patents- One on the platform for obtaining molecular information from clinical
specimens and integrating with clinical information (Topographic Genotyping, issued 2001). One
on the diagnosis, determination of malignant potential and biological potential of pancreatic
cysts. One on an improved method for determination of pancreatic cyst fluid CEA levels.
Barrettās esophagus: Two patents pending- Use of mutational load to assess likelihood of
progression of Barrettās esophagus and corresponding need for treatment.
Proprietary attributes: Extensive experience in managing extremely low quality, fixative treated
clinical specimens. Lab information management system that extracts results from database and
allows efficient integration of molecular and clinical results. Analysis of DNA, mRNA and
microRNA from fresh, cytology and paraffin embedded samples including residual material
contained cell-free nucleic.
37. GASTROINTESTIONAL(GI) PRODUCTS
ļ¼ Launched new Biliary product October 3rd, 2016
ļ¼ Launched AccuCEAā¢ Insights August 1st, 2016
ļ¼ Launched BarreGenĀ® CEP September 1st, 2016
ENDOCRINE PRODUCTS
ļ¼ Launched Cytopathology Services October 1st, 2016
ļ¼ Launched Cytology Slides as primary specimen
October 1st, 2016
Recent Product Developments
38. Summary
ļ± We are NASDAQ listed and we recently were recognized for compliance by NASDAQ for our stock price
and our positive stockholdersā equity in excess of $2.5 million
ļ± We had a successful transition in 2015/2016 to a standalone company
ļ± Completely eliminated all of our secured debt as of the end of the day yesterday.
ļ± Yesterday we traded in excess of 50 million shares as we announced our reimbursement approval for
ThyraMIR by UnitedHealthcare.
ļ± Raised $14 million in 60 days since the end of the year.
ļ± We have growing revenue (39% YoY) and reimbursement with a pathway to break-even
ļ± Key products are covered by Medicare
ļ± A dedicated sales force that is able to be āleveragedā
ļ± New product extensions, reimbursement approval and commercial opportunities late in 2016
ļ± Business development opportunities and large market pipeline product in BarreGEN
38