1. PREVENTEST Final Go Live Training Get Ready to Sell. www. PrevenTests
PREVENTEST Final Go Live Training Get Ready to Sell!
Presented by David Gruber
National Sales Director, GeneID

2. 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

3. Easy test to “Sell” But the Key is in the “Execution”
Give 10 Point Questionnaire to Each Patient who comes into office (on clipboard)
If patient scores 10 or more points they are eligible for test
Fill out Requisition form, and Consent form and perform mouthwash and swab
Put all back into black envelope and send fed ex after a minimum of 5 tests

4. Questionnaire to determine if patient qualifies
To be included on clipboard for all patients coming in for appointment
Can be ed or mailed to patients in practice database

5. 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
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

6. About Our Scientific Director Dr. Daniel Cohen, M.D.
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

7. 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

8. Catching Cancer Early is Critical

9. 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

10. We are in the Right Space at the Right Time!!
The Next Generations Sequencing (NGS) Market is growing exponentially!
The Affordable Care Act has made Precision Medicine and Genetic Testing a Priority
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
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

11. The NGS market is the fastest growing in Genomics…2014 Revenue was $2
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:
release/2015/06/13/744356/ /en/Next-Generation-Sequencing- Market-Is-Anticipated-To-Grow-To Billion-In-2022-New-Report-By- Grand-View-Research-Inc.html#sthash.05I27CkA.dpuf

12. Obama Announces “Precision Medicine Initiative” (Jan
Obama Announces “Precision Medicine Initiative” (Jan. 30, 2015) and Affordable Care Act
$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.
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."

13. New Clinical Studies Discovering More Gene Mutations that Cause Cancer
Published: In the prestigious New England Journal of Medicine August 7th, (
Title: Breast-Cancer Risk in Families with Mutations in PALB2
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

14. 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

15. 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)

16. Evolution of Hereditary Cancer Risk Testing… from 2 Genes to Multi-Gene 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

17. 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

18. Testing More Genes identifies more Cancers?
2013 San Antonio Breast Cancer Symposium (Myriad Funded Study)
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)
Myriad had reported a 61% improvement in detection of hereditary colon cancer by testing 25 Genes

19. 1. “Why Should I test for Cancer Risk?”
The Risk for Cancer is significantly increased with a Genetic Mutation

20. 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!

21. 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

22. 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)

24. 31 Genes Linked to 8 Cancers
The Panel of Genes
31 Genes Linked to 8 Cancers
6 more genes than Myriad
RET
ELAC2
HRAS1
MRE11A
PTCH1
RAD50

25. What Myriad is Missing Gene Breast Ovarian Colorectal Endometrial
Melanoma
Pancreatic
Gastric
Prostate
Other
ELAC2 ●
HRAS1
MRE11A
PTCH1
RAD50
RET
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: , 2002.
Association of HPC2/ELAC2 genotypes and prostate cancer. Rebbeck TR et al. Am. J. Hum. Genet. 67: , 2000.
Cancer Epidemiol Biomarkers Prev Dec;12(12): 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, (3): p. R58
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 Jul;117(2-3): 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.

26. One Mutation can increase the likelihood of many cancers
Lynch Syndrome:
A “Cancer Syndrome” defined by a mutation in one of 5 Genes: MLH1
MSH2
MSH6
PMS2
EPCAM
Increases risk of Colon, Endometrial, Ovarian, Skin and Stomach Cancer

28. Selling the PREVENTEST Tips and Tactics that Work!

29. 2 Steps to Success
Qualify the Patient for the Test ensure Medical Necessity is met based on personal and family history of cancer
Insurance Approval ensure the test will be paid for with zero to minimal out of pocket expense for the patient

30. Performance Goals Oct: 15-25 Tests Nov: 25-50 Tess
Ramp up to Paid Tests/Month minimum
Sept: Tests
Oct: Tests
Nov: Tess
And Upward from There!

31. Where Does Your Business Come From?
PCPs (40+ tests/month)
OB/GYNs (20+ tests/Doc/Month)
General Oncologists (40+ tests/month)
Breast Surgeons (40+ tests+/month)
Others: Large Practices (GI, Wellness, etc.)

33. Insurance Approval Process
Medicare or Medicaid
Verification of Active Insurance
Patient called to verify history listed on Requisition form
Test Run
Test Reported and Billed
Test Collected
Commercial Insurance or Medicare Advantage Plans
Verification of Active Insurance
Confirm that our CPT codes are covered by the plan for that patient
Submit any additional information they require (mostly Medical Notes)
Get approval from Insurance to Run (3 days-3 weeks)
Test Run
Test Reported and Billed
Test Collected

34. Submit Tests with Clinical Notes (to speed things up)

35. Good Screening is the Key to Success!

36. Related Cancers (2 categories)
BRCA Cancers
Breast
Ovarian
Prostate
Pancreas
Lynch Cancers
Colon/Colorectal
Uterus/Endometrial
Pancreas
Ovarian
Stomach/Gastric
Brain
Kidney

37. 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

38. 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

39. Cancer History that does NOT Qualify
Lung Cancer
Skin Cancer
Liver Cancer
Bone Cancer
Throat Cancer
Esophageal Cancer
Heart Cancer
Cervical Cancers
Thyroid
Blood Cancers (Leukemia, Lymphoma, Hodgkin's)

40. 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)

41. Write your name on the top of the Req form
Requisition Form Very Important: Fill in All Applicable Information -Need Ages of Cancer Diagnosis -Need Doc Sig -Need Patient Sig -Need Insurance Info

42. ICD 9 Codes for Personal History

43. “Does This Test Qualify?”

44. “Does This Test Qualify?”

45. “Does This Test Qualify?”

46. “Does This Test Qualify?”

47. The “Kit” Envelope Test Kit Requisition Form
Sample Collection Instructions
Consent Form (signed by doc and patient
Pre-Paid Fed Ex Return Label

48. Test Kit
1 Swab
Tube for Mouthwash
Mouthwash

49. Non-Invasive Sample Collection Method

50. To Complete Kit:
Pick up softpack FedEx Express envelopes and insert in kits and leave with offices

51. Marketing/Support Materials
-PREVENTEST Website
-Video illustrating “PREVENTEST” (Great to mail to potential customers)
PREVENTEST 2 Minute Video Description in English:
PREVENTEST 2 Minute Video Description in Spanish:
-Sales Support
-Dropbox with sales materials
-Sales Status Reports once/week
-Test Kits and Patient Education leave behinds
-Genetic Counseling Referral company

52. The “New Client” Form
Fill out completely and send to you distributor lead:
Or fax to lab: (201)
This is what links the Doctor/Office to you so you will get credit for the tests that are sent into the lab

53. 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”
Don’t mistake “Excitement” for “Commitment”
High Frequency on a few (3-5) Offices until they routinely send tests

54. #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

55. Office Posters to be placed in waiting room and exam rooms to generate awareness)
(Version 1)

56. Office Posters to be placed in waiting room and exam rooms to generate awareness (Version 2)

57. Questionnaire to determine if patient qualifies
To be included on clipboard for all patients coming in for appointment
Can be ed or mailed to patients in practice database

58. Simple Test Process Give 10 Point Questionnaire to Each Patient
If patient scores 10 or more points they are eligible for test
Fill out Requisition form, and Consent form and perform mouthwash and swab
Put all back into black envelope and send fed ex after a minimum of 5 tests

59. 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)

60. To the Dropbox…
Selling Materials