Transcript Breast cancer diagnosed at age - Life

PREVENTEST
Final Go Live Training
Get Ready to Sell!
www.PrevenTests.com
Presented by David Gruber
National Sales Director, GeneID
914-262-5042 [email protected]
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
Easy test to “Sell”
But the Key is in the “Execution”
1. Give 10 Point Questionnaire to Each Patient
who comes into office (on clipboard)
2. If patient scores 10 or more points they are
eligible for test
3. Fill out Requisition form, and Consent form
and perform mouthwash and swab
4. Put all back into black envelope and send fed ex
after a minimum of 5 tests
Questionnaire to determine if patient qualifies
To be
included on
clipboard for
all patients
coming in for
appointment
Can be
emailed or
mailed to
patients in
practice
database
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

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 a 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
Catching Cancer Early is Critical
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:
Qualifying
PREVENTEST
Cancer Types
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.
The Competition is Helping Us! Myriad Labs (company that
started BRCA testing) is helping spread the message that “testing
more genes results in the detection of more cancers” through
their MyRISK test
The NGS market is the fastest growing in
Genomics…2014 Revenue was $2.4 Billion
growing to almost $28 Billion by 2022
Expected Market Growth:
Next Generation Sequencing Market Is Anticipated To
Grow To $27.87 Billion In 2022: New Report By Grand
View Research, Inc.
Fueled by Cancer Genetics!
See more at:
http://globenewswire.com/newsrelease/2015/06/13/744356/10138308/en/Next-Generation-SequencingMarket-Is-Anticipated-To-Grow-To-27-87-Billion-In-2022-New-Report-ByGrand-View-Research-Inc.html#sthash.05I27CkA.dpuf
Obama Announces “Precision Medicine
Initiative” (Jan. 30, 2015) and Affordable
Care Act
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$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 treatment
and preventative care.
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BRCA Testing Granted “Preventative Care Designation Under the
Affordable Care Act”
-Women who have a high risk of developing breast cancer can receive genetic
counseling and BRCA testing for free as a preventive service under the law, says
a spokeswoman for the Department of Health and Human Services.
-According to federal guidelines regarding the implementation of the Affordable Care
Act, "genetic counseling and BRCA testing, if appropriate, must be made available
as a preventive service without cost-sharing."
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: Combination
of 1, 2 or 3 Family members on the same side of the
family with a related cancer (Depending on type cancer
and age)
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
Selling the PREVENTEST
Tips and Tactics that Work!
2 Steps to Success
1. Qualify the Patient for the Test
-ensure Medical Necessity is met based on
personal and family history of cancer
2. Insurance Approval
-ensure the test will be paid for with zero to
minimal out of pocket expense for the patient
Performance Goals
 Ramp up to 50-100 Paid Tests/Month
minimum
Sept:
10-15 Tests
Oct:
15-25 Tests
Nov:
25-50 Tess
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.)
Insurance Approval Process
Medicare or Medicaid
1.
2.
Verification of Active
Insurance
Patient called to verify
history listed on
Requisition form
3.
Test Run
4.
Test Reported and Billed
5.
Test Collected
Commercial Insurance or Medicare Advantage
Plans
1.
Verification of Active Insurance
2.
Confirm that our CPT codes are covered by the
plan for that patient
3.
Submit any additional information they require
(mostly Medical Notes)
4.
Get approval from Insurance to Run (3 days-3
weeks)
5.
Test Run
6.
Test Reported and Billed
7.
Test Collected
Submit Tests with Clinical Notes
(to speed things up)
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
Genetic Testing Criteria (Commercial Insurance Female and Male)
Personal History of (any one of the below):
 Breast cancer diagnosed at age <50
 Ovarian cancer diagnosed at any age
 Colon cancer diagnosed at age <50
 Prostate or Pancreatic cancer plus 1 or more family member with Pancreatic, Prostate,
Breast (diagnosed <50) or Ovarian Cancer
 Colon cancer (any age) plus 1 or more family members with Pancreas, Stomach, Brain,
Uterine, or Kidney cancer (any age)
 If Ashkenazi Jewish, no additional family history may be required
Family History of (any one of the below):
 1 Relative w/Ovarian cancer (any age)
 1 Relative w/Breast cancer (diagnosed <45)
 1 Relative w/Breast cancer (diagnosed <50) plus 1 or more Relatives with Breast,
Pancreas, Prostate or Ovarian cancer (any age)
 1 Relative w/Breast cancer (any age) plus 2 or more Relatives with Breast, Pancreas or
Prostate Cancer (any age)
 2 or more Relatives with Breast, Prostate, Ovarian 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
Genetic Testing Criteria (Medicare Insurance Female and Male)
Personal History of (any one of the below):
 Breast cancer, Ovarian cancer or Colorectal cancer
 For breast, ovarian and colorectal cancers, the patient must have
cancer – defined as current or has been in remission for less than
5 years
 Pancreatic Cancer or Prostate Cancer
 For pancreatic and prostate cancers, patient must also have 1
relative with either: breast cancer < 50, ovarian cancer, pancreatic
cancer or prostate 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
• 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, grandmother, grandfather, son,
daughter, 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
-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”
Envelope
Test Kit
Requisition Form
Sample Collection
Instructions
Consent Form (signed by
doc and patient
Pre-Paid Fed Ex
Return Label
Test Kit
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
To be
included on
clipboard for
all patients
coming in for
appointment
Can be
emailed or
mailed to
patients in
practice
database
Simple Test Process
1. Give 10 Point Questionnaire to Each Patient
2. If patient scores 10 or more points they are
eligible for test
3. Fill out Requisition form, and Consent form
and perform mouthwash and swab
4. Put all back into black envelope and send fed ex
after a minimum of 5 tests
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