PREVENTEST
Final Go Live Training
Get Ready to Sell!
www.PrevenTests.com
Presented by David Gruber
National Sales Director, GeneID
914-262-5042 sales@geneidlab.com
Conducting Business the
“Right” Way
 GeneID and all of its Distributors and Sales
Representatives must comply with all Federal, State,
and Local Healthcare Laws, Policies and Procedures
 This Includes: Anti-Kickback, Stark, and HIIPA
 GeneID employs a “No Tolerance” approach to
compliance violations
About GeneID?

GeneID is a CLIA and CAP (College of American Pathology) Certified
Molecular Laboratory specializing in Next Generation DNA Gene
Sequencing using the Ion Torrent Micro Chip Technology by Life
Technologies
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The microchip contains over 140 million mini Test Tubes which allow
us to be very accurate, cost effective, do many tests at once and
have a very quick turnaround time
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We are based in Ramsey, NJ and service all states except NY

Our staff includes a CEO, Scientific Director, Medical Director, Billing
Department, Lab Technicians, Sales Support, Access to Genetic
Counselors, and national Field Sales Team
About Our Scientific Director
Dr. Daniel Cohen, M.D.
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Double Board Certified M.D. in OB/GYN and Genetics
Expert in NGS
Human Genome Project BRCA Protocol Lead, Argentina
Twice Listed in Who’s Who of Science: 1996 and 2013
Director of 4 molecular laboratories
Oversees all testing in the GeneID Laboratory
Why Genetic Testing for Cancer
Risk is so important…
• Patients who have or had cancer caused by a
genetic mutation are at significant risk for
another related cancer
• Family members of patients with cancer are at
a higher risk for developing a related cancer
• Preventing Cancer is a much better than being
treated for cancer
Introducing The GeneID PREVENTEST; a New, First-to-Market,
non-invasive cancer risk pre-disposition test analyzing 31 Genes
linked to 8 of the most common solid tumor hereditary cancers:
We are in the Right Space at the Right Time!!
1.
The Next Generations Sequencing (NGS) Market is
growing exponentially!
2.
The Affordable Care Act has made Precision Medicine and
Genetic Testing a Priority
3.
There is a tremendous investment being made into
Research and Technology resulting in more knowledge
about which Gene mutations contribute to which cancers
and suggesting even more people should be tested
4.
Myriad Labs is helping spread the message that “testing
more genes in addition to BRCA 1 and 2 results in the
detection of more cancers” through their MyRISK test
Our Market is Young and Growing!!
Expected Market Growth:
The next generation sequencing market is rapidly
evolving with a large number of developments taking
place to increase accuracy and speed, and reduce costs of
sequencing. It is the fastest-growing and most lucrative
segment in the genomics space with an estimated
growth of 23.1%. The global NGS market will be worth
$2.5 billion in 2014 and is poised to reach $8.7 billion by
2020.
Source: MarketsandMarkets.com (Sept. 2014)
http://marketsandmarkets.com/Market-Reports/next-generation-sequencing-ngstechnologies-market-546.html
Obama Announces “Precision Medicine
Initiative” (Jan. 30, 2015)
 $217 Million dollar initiative that moves away from one-
size-fits-all treatments
 Scientists will assemble databases of about a million
volunteers to study their genetics …to learn how to
individualize care.
 Doctors would study genetics to individualize care
Plus…BRCA Testing Granted Preventive Care Designation
Under the Affordable Care Act
http://tablet.olivesoftware.com/Olive/Tablet/AtlantaJournalConstitution/S
haredArticle.aspx?href=AJC/2015/01/31&id=Ar00603
New Clinical Studies Discovering More
Gene Mutations that Cause Cancer
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Published: In the prestigious New England Journal of Medicine
August 7th, 2014
(http://www.nejm.org/doi/full/10.1056/NEJMoa1400382)
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Title: Breast-Cancer Risk in Families with Mutations in PALB2
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Results:
The absolute breast-cancer risk for PALB2 female mutation
carriers by 70 years of age ranged from 33% for those with no
family history of breast cancer to 58% for those with two or more
first-degree relatives with breast cancer at 50 years of age.
***PALB2 is on our PREVENTEST Panel
What is Genetic Testing for Cancer Risk?
 Predictive testing that can help predict
the likelihood that an individual will
develop cancer in his or her lifetime
 Not everyone with a cancer-related gene
will develop cancer
Who may be at risk for developing hereditary
cancer and who should be tested? What
criteria determine Medical Necessity?
 People with Personal history of cancer
 People with a family member who tested positive for
a BRCA mutation
 People with a Family history of cancer: Two or more
relatives on the same side of the family with a related
cancer (one must be under age 50)
Evolution of Hereditary Cancer Risk
Testing… from 2 Genes to MultiGene Panel Testing
Early 90’s
-BRCA 1 and 2 Discovered by several scientists (Mary Claire King)
-Myriad granted a patent on the BRCA 1-2 Genes and has monopoly on market
-Myriad launched BRCAnalysis, a predictive medicine product for hereditary
breast and ovarian cancer (testing BRCA 1-2) in 1996
-Supreme Court Overturns Myriad BRCA 1-2 Patent in June 2013 opening
market to other labs (Ambry, GeneDx, LabCorp, Quest, etc)
-Move FROM just testing for BRCA 1&2 to Multiple Gene Testing
We are ahead of the
Competition…
“After the Supreme Court last year ruled that Myriad Genetics could not
patent the BRCA1 and BRCA2 genes, the company announced that by
2015 it would replace its BRCAnalysis test with a broader myRisk panel
that analyzes 25 genes associated with hereditary cancers, including
breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric, and
melanoma”
***And they will be using Next Generation Sequencing!
***Have been piloting for about 6 months ($50m in sales)
***Blood Draw vs. Cheek Swab with PREVENTEST
***25 Genes vs. 31 with PREVENTEST
Testing More Genes identifies
more Cancers?
2013 San Antonio Breast Cancer Symposium (Myriad Funded Study)
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It was found that myRisk testing for 25 genes has the ability to identify
51% more patients with higher risk of hereditary breast and ovarian
cancer than testing of BRCA1 and BRCA2 genes alone.
2013 Collaborative Group of the Americas on Inherited Colorectal Cancer
(CGA) Annual Meeting (Myriad Funded Study)
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Myriad had reported a 61% improvement in detection of hereditary
colon cancer by testing 25 Genes
1. “Why Should I test for
Cancer Risk?”
2. “Why would my patients
want to know this information?”
Because if they know that they are
genetically pre-disposed to any of
these 8 cancers, they can reduce the
risk or even PREVENT the cancer
from occurring!
What this information allows you
to do…Take Control and develop a
preventative plan!
 People at a higher risk for cancer may have the option of having:
1. More frequent cancer screenings
2. Avoiding specific risk factors
3. Making lifestyle changes to lessen additional risk
4. Taking preventive medication (chemoprevention)
5. Having risk reducing surgeries in order to reduce their risk
3. “What do I do with the information?”
 You do the same thing that you would do if you have an out
of control diabetic or blood pressure patient…refer them to a
Specialist…a Genetic Counselor
1. First bring patient back into office and review results
2. If positive refer them to a local Genetic Counselor or
utilize Telephone Consultation Genetic Counselor
experts (Informed DNA)
The Panel of Genes
What Myriad is Missing
Gene
ELAC2
HRAS1
MRE11A
PTCH1
RAD50
RET
Breast
Ovarian Colorectal Endometrial Melanoma Pancreatic
Gastric
Prostate
Other
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• Meta-analysis of associations of the ser217-to-leu and ala541-to-thr variants in ELAC2 (HPC2) and prostate cancer. Camp NJ et al. Am. J. Hum. Genet. 71: 1475-1478, 2002.
• Association of HPC2/ELAC2 genotypes and prostate cancer. Rebbeck TR et al. Am. J. Hum. Genet. 67: 1014-1019, 2000.
• Cancer Epidemiol Biomarkers Prev. 2003 Dec;12(12):1528-30.The HRAS1 variable number of tandem repeats and risk of breast cancer.Tamimi RM, Hankinson SE, Ding S,
Gagalang V, Larson GP, Spiegelman D, Colditz GA, Krontiris TG, Hunter DJ
• Damiola, F., et al., Rare key functional domain missense substitutions in MRE11A, RAD50, and NBN contribute to breast cancer susceptibility: results from a Breast Cancer
Family Registry case-control mutation-screening study. Breast Cancer Res, 2014. 16(3): p. R58
• http://ghr.nlm.nih.gov/gene/PTCH1
• Screening for BRCA1, BRCA2, CHEK2, PALB2, BRIP1, RAD50, and CDH1 mutations in high-risk Finnish BRCA1/2-founder mutation-negative breast and/or ovarian cancer
individuals. Kuusisto KM et al. Breast Cancer Research 2011, 13:R20.
• Hum Genet. 2005 Jul;117(2-3):143-53. A newly identified RET proto-oncogene polymorphism is found in a high number of endocrine tumor patients. Gartner W, Mineva I,
Daneva T, Baumgartner-Parzer S, Niederle B, Vierhapper H, Weissel M, Wagner L.
One Mutation can increase the
likelihood of many cancers
Performance Goals
 Ramp up to 50-100 Paid Tests/Month
minimum
May:
10-15 Tests
June:
25-50 Tests
And Upward from There!
Where Does Your Business Come From?
1. PCPs
(40+ tests/month)
2. OB/GYNs (20+ tests/Doc/Month)
3. General Oncologists (40+ tests/month)
4. Breast Surgeons (40+ tests+/month)
5. Others: Large Practices (GI,
Wellness, etc.)
Good Screening is the
Key to Success!
Related Cancers (2 categories)
BRCA Cancers
Lynch Cancers
•Breast
•Ovarian
•Prostate
•Pancreas
• Colon/Colorectal
• Uterus/Endometrial
• Pancreas
• Ovarian
• Stomach/Gastric
• Brain
• Kidney
Qualified Patient Criteria Combinations
Female Personal History of:
 Breast or Ovarian cancer (any age)
 Colon Cancer (< 60)
Female with Family History of:
 1 Relative w/Ovarian cancer (any age)
 1 Relative w/Breast cancer (diagnosed <45)
 2 or more Relatives with Breast, Prostate and/or
Pancreatic cancer with 1 diagnosed <50
 2 or more Relatives with Colon, Uterus,
Pancreatic, Stomach, Brain and/or Kidney
cancer with 1 diagnosed <50
 3 or more Relatives with any of the above groups
of cancer diagnosed at any age
Relatives need to be on same side of family
Female Other:
 Patient is Ashkenazi Jewish with 1
Relative w/Breast cancer (any age)
Male must have Personal History of Cancer
Male Personal History of:
 Colon Cancer (< 60)
 Colon (>60), Pancreas, Stomach, Brain
and/or Kidney cancer PLUS 1 family
member with a related cancer
diagnosed at any age
 Prostate Cancer Plus 2 family
members with any combination of
Prostate, Breast, Ovarian, and/or
Pancreatic cancer (any age)
 Male Breast Cancer
Cancer History that does NOT Qualify
1. Lung Cancer
2. Skin Cancer
3. Liver Cancer
4. Bone Cancer
5. Throat Cancer
6. Esophageal Cancer
7. Heart Cancer
8. Cervical Cancers
9. Thyroid
10. Blood Cancers (Leukemia,
Lymphoma, Hodgkin's)
Some key rules to Remember
• For Medicare, Males with NO PERSONAL History
does not qualify
• Colon and Breast are not “Related Cancers”
• Skin is not “In” and does not count as a qualifier
• Family Members need to be on same side of family
and 1st or 2nd degree relatives (mother, father,
sister, brother, aunt, uncle, niece, nephew, ½
brother/sister)
Requisition Form
Very Important:
Fill in All Applicable
Information
-Need Ages of
Cancer Diagnosis
-Need Doc Sig
-Need Patient Sig
S
-Need Insurance Info
Write your
name on
the top of
the Req
form
ICD 9 Codes for Personal History
“Does
This Test
Qualify?”
“Does
This Test
Qualify?”
“Does
This Test
Qualify?”
“Does
This Test
Qualify?”
The “Kit”
New Non-Invasive Sample Collection Method
To Complete Kit:
 Pick up softpack FedEx Express envelopes
and insert in kits and leave with offices
Marketing/Support Materials
-PREVENTEST Website www.PrevenTests.com
-Video illustrating “PREVENTEST” (Great to mail to potential customers)
PREVENTEST 2 Minute Video Description in English:
https://vimeo.com/96718022
PREVENTEST 2 Minute Video Description in Spanish:
https://vimeo.com/112819235
-Sales Support
-Dropbox with sales materials
-Sales Status Reports once/week
-Test Kits and Patient Education leave behinds
-Genetic Counseling Referral company
The “New Client” Form
Fill out completely and send to
you distributor lead:
Or fax to lab: (201) 825-0191
This is what links the
Doctor/Office to you so you will
get credit for the tests that are
sent into the lab
Keys to Success

Keep it Simple with your customers…so don’t overcomplicate the
message by trying to talk “high science”

Our message is: “Doctor, with NGS technology, you can now, with a
simple cheek swab, predict the risk of 8 serious solid tumor cancers
so that your patients can put a preventative plan in place”
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Don’t mistake “Excitement” for “Commitment”
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High Frequency on a few (3-5) Offices until they routinely send tests
#1 Key to Success
Make Screening for Cancer a
“standard” in the office (just like they
screen for cholesterol and blood pressure)
USE THE CUSTOMIZABLE OFFICE
POSTERS and PATIENT
QUESTIONNAIRE to profile the most
appropriate candidates
Office Posters to be placed in waiting room and exam rooms to generate awareness)
(Version 1)
Office Posters to be placed in waiting room and exam rooms to
generate awareness (Version 2)
(Version 2)
Questionnaire to determine if patient qualifies (version 1)
To be
included on
clipboard for
all patients
coming in for
appointment
Can be
emailed or
mailed to
patients in
practice
database
Questionnaire to determine if patient qualifies (version 2)
To be
included on
clipboard for
all patients
coming in for
appointment
Can be
emailed or
mailed to
patients in
practice
database
Feedback Mechanism/Other
Suggestions
 Ask Office to text or call you when a test is coming
in and let your distributor know
 Conference Calls to share successes (GeneID call
every Friday at 11:15AM EST)
 Encourage Multiple tests/Fed Ex shipment
 Request additional kits through your distributor
(New Kits will only be sent once we receive 5 tests)
To the Dropbox…
Selling Materials