PREVENTEST Final Go Live Training

Get Ready to Sell!

www.PrevenTests.com

Presented by David GruberNational Sales Director, GeneID

914-262-5042 sales@GeneIDLab.com

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

Conducting Business the “Right” Way

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

Can be emailed or mailed to patients in practice database

To be included on clipboard for all patients coming in for appointment

Questionnaire to determine if patient qualifies

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

About GeneID?

About Our Scientific DirectorDr. 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

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/news-release/2015/06/13/744356/10138308/en/Next-Generation-Sequencing-Market-Is-Anticipated-To-Grow-To-27-87-Billion-In-2022-New-Report-By-Grand-View-Research-Inc.html#sthash.05I27CkA.dpuf

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."

Published: In the prestigious New England Journal of Medicine August 7th, 2014 (http://www.nejm.org/doi/full/10.1056/NEJMoa1400382)

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

New Clinical Studies Discovering More Gene Mutations that Cause

Cancer

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

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

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)

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

1. “Why Should I test for Cancer Risk?”

The Risk for Cancer

is significantly increased

with a Genetic Mutation

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)

31 Genes Linked to 8

Cancers

6 more genes than Myriad

RETELAC2HRAS1

MRE11APTCH1RAD50

The Panel of Genes

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: 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

cancersLynch Syndrome:

A “Cancer Syndrome” defined by a mutation in one of 5 Genes: MLH1MSH2MSH6PMS2EPCAM

Increases risk of Colon, Endometrial, Ovarian, Skin and Stomach Cancer

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. Verification of Active Insurance

2. 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

•Breast•Ovarian•Prostate•Pancreas

Lynch Cancers

• 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 Cancer2. Skin Cancer3. Liver Cancer4. Bone Cancer5. Throat Cancer6. Esophageal Cancer7. Heart Cancer8. Cervical Cancers9. Thyroid10. 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”

Requisition Form

Pre-Paid Fed Ex Return Label

Sample Collection Instructions

Consent Form (signed by doc and patient

Envelope Test Kit

Test Kit

Tube for Mouthwash

1 Swab

Mouthwash

Non-Invasive Sample Collection Method

To Complete Kit:

Pick up softpack FedEx Express envelopes and insert in kits and leave with offices

-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

Marketing/Support Materials

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”

Don’t mistake “Excitement” for “Commitment”

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)

Can be emailed or mailed to patients in practice database

To be included on clipboard for all patients coming in for appointment

Questionnaire to determine if patient qualifies

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

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)

Feedback Mechanism/Other

Suggestions

To the Dropbox…

Selling Materials