PATIENT GUIDE
`
`Indication for Use
`Cologuard is intended for the qualitative detection of colorectal neoplasia associated
`DNA markers and for the presence of occult hemoglobin in human stool. A positive
`result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA)
`and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen
`adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard
`is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk
`individuals.
`
`IVD
`
`For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` Rx Only
`
`Exact Sciences
`Madison WI USA
`
`LBL-0207rev3
`
`Patent Owner's Ex. 2016, Page 1
`
`Geneoscopy Exhibit 1076, Page 1
`
`
`
`Indication for Use
`Cologuard is intended for the qualitative detection of colorectal neoplasia associated
`DNA markers and for the presence of occult hemoglobin in human stool. A positive
`result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA)
`and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen
`adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard
`is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk
`individuals.
`
`IVD
`
`For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` Rx Only
`
`Exact Sciences
`Madison WI USA
`
`LBL-0207rev3
`
`Patent Owner's Ex. 2016, Page 1
`
`Geneoscopy Exhibit 1076, Page 1
`
`
`
`
`
`
`
`
`
`Table of Contents
`
`Contra-Indications ………………………………………………………………………………….. 3
`Cologuard Warnings and Precautions …..………………………………………………… 4-5
`How the Cologuard Collection Kit Works ………………………………………………… 6
`What Does the Cologuard Test Result Mean ..……………………………………..… 7
`What Is Inside the Cologuard Collection Kit …………………………………………... 8
`Who Should Use Cologuard? ……………………………………………………………….... 9
`Caution ……………………………………………………………………………………................. 10
`Risks ………………………………………………………………………………………………………. 10
`What Should I Know Before Using the Cologuard Collection Kit?..... 11
`When Should I Not Use the Cologuard Collection Kit? ………………….. 12
`How to Use the Cologuard Collection Kit…………………………………………………. 13 -31
`Glossary ………………………………………………………………………………………………..… 32
`Symbols Used on the Cologuard Collection Kit ………………………………………… 33
`Clinical Study Results……………………………………………………………………………….. 33
`
`Page 2
`
`For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` Rx Only
`
`Patent Owner's Ex. 2016, Page 2
`
`Geneoscopy Exhibit 1076, Page 2
`
`
`
`
`Contra-Indications
`Cologuard is intended for use with patients, age 50 years and older, at average
`risk who are typical candidates for CRC screening. Cologuard was not clinically
`evaluated for the following types of patients:
`(cid:120) Patients with a history of colorectal cancer, adenomas, or other related
`cancers.
`(cid:120) Patients who have had a positive result from another colorectal cancer
`screening method within the last 6 months.
`(cid:120) Patients who have been diagnosed with a condition that is associated with
`high risk for colorectal cancer. These include but are not limited to:
`o Inflammatory Bowel Disease (IBD)
`o Chronic ulcerative colitis (CUC)
`o Crohn’s disease
`o Familial adenomatous polyposis (FAP)
`o Family history of colorectal cancer
`(cid:120) Patients who have been diagnosed with a relevant familial (hereditary)
`cancer syndrome, such as Hereditary non-polyposis colorectal cancer
`syndrome (HNPCCC or Lynch Syndrome), Peutz-Jeghers Syndrome, MYH-
`Associated Polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s)
`syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada
`syndrome, Neurofibromatosis, or Familial Hyperplastic Polyposis.
`
`
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 3
`
`Patent Owner's Ex. 2016, Page 3
`
`Geneoscopy Exhibit 1076, Page 3
`
`
`
`
`
`
`
`
`Cologuard Warnings and Precautions
`
`(cid:120) The performance of Cologuard has been established in a cross sectional
`study (i.e., single point in time). Programmatic performance of Cologuard
`(i.e., benefits and risks with repeated testing over an established period of
`time) has not been studied. Performance has not been evaluated in adults
`who have been previously tested with Cologuard. Non-inferiority or
`superiority of Cologuard programmatic sensitivity as compared to other
`recommended screening methods for CRC and AA has not been established.
`(cid:120) CRC screening guideline recommendations vary for persons over the age of
`75. The decision to screen persons over the age of 75 should be made on an
`individualized basis in consultation with a healthcare provider. Cologuard
`test results should be interpreted with caution in older patients as the rate of
`false positive results increases with age.
`(cid:120) A negative Cologuard test result does not guarantee absence of cancer or
`advanced adenoma. Patients with a negative Cologuard test result should be
`advised to continue participating in a colorectal cancer screening program
`with another recommended screening method. The screening interval for
`this follow-up has not been established.
`(cid:120) Cologuard may produce false negative or false positive results. A false
`positive result occurs when Cologuard produces a positive result, even
`though a colonoscopy will not find cancer or precancerous polyps. A false
`negative result occurs when Cologuard does not detect a precancerous polyp
`or colorectal cancer even when a colonoscopy identifies the positive result.
`
`
`
`Page 4
`
`For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` Rx Only
`
`Patent Owner's Ex. 2016, Page 4
`
`Geneoscopy Exhibit 1076, Page 4
`
`
`
`
`
`
`Cologuard Warnings and Precautions
`
` (cid:120)
`
` Patients should not provide a sample for Cologuard if they have diarrhea or if
`they have blood in their urine or stool (e.g., from bleeding hemorrhoids,
`bleeding cuts or wounds on their hands, rectal bleeding, or menstruation).
`(cid:120) To ensure the integrity of the sample, the laboratory must receive the
`patient specimens within 72 hours of collection. Patients should send stool
`samples to the laboratory according to the instructions stated in the
`Cologuard Patient Guide.
`(cid:120) Patients should be advised of the caution listed in the Cologuard Patient
`Guide. Patients should NOT drink the preservative liquid.
`(cid:120) The risks related to using the Cologuard Collection Kit are low, with no
`serious adverse events reported among people in a clinical trial. Patients
`should be careful when opening and closing the lids to avoid the risk of hand
`strain.
`
`
`
`
`
`
`
`
`
`
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 5
`
`Patent Owner's Ex. 2016, Page 5
`
`Geneoscopy Exhibit 1076, Page 5
`
`
`
`How the Cologuard Collection Kit Works
`
`Your doctor has ordered Cologuard to screen for colorectal cancer and precancer.
`
`Cologuard is a screening test that uses a stool sample (your bowel movement) to
`detect colorectal cancer and precancer. Every day, your colon sheds cells that line
`the colon. As part of this process, normal cells along with abnormal cells from
`precancer or cancers are shed into the colon. Your stool picks up those cells as it
`passes through your colon. Cologuard is designed to detect the DNA and
`hemoglobin released from these abnormal cells in your stool.
`
`The Cologuard collection kit is used to collect your stool sample. After you collect
`your stool sample following the instructions in this Patient Guide, the collection
`kit will be delivered to a lab. The lab will test your stool sample and send the
`results to your doctor. Your doctor will contact you with the test results.
`
`Note: You are not required to change your diet or medications to use this screening test.
`
`You can store your kit until you are ready to use it.
`o Store at room temperature.
`o Keep away from heat and direct sunlight.
`o Keep out of the reach of children.
`
`Page 6
`
`For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` Rx Only
`
`Patent Owner's Ex. 2016, Page 6
`
`Geneoscopy Exhibit 1076, Page 6
`
`
`
`
`What Does the Cologuard Test Result Mean?
`Your doctor will talk with you about your results. The test result can be Positive, Negative or
`No result obtained.
`
`What Does a Positive Result Mean?
`• A Positive result means the test detected abnormal DNA and/or blood that could be
`caused by precancer or cancer in the colon.
`• The test can also have a Positive result that is incorrect (false positive). This means the
`test result is Positive, but no cancer or precancer is actually present.
`• Any Positive result should be followed by a colonoscopy.
`• Talk about your test result with your doctor to find out if additional testing is needed.
`
`
`What Does a Negative Result Mean?
`• A Negative test result means the test did not detect abnormal DNA and/or blood in the
`sample.
`• The test can also have a Negative result that is incorrect (false negative). This means the
`test result missed a potential cancer or precancer. For that reason, it is recommended
`that you schedule regular screenings.
`• Talk to your doctor about your test result. Your doctor will recommend a screening
`schedule that is best for you.
`
`
`What Does No Result Obtained Mean?
`• A “No Result Obtained” means the test was not able to provide a result.
`• If this happens, your doctor will talk with you about the next steps. For example, you may
`be asked to provide another stool sample to test.
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 7
`
`Patent Owner's Ex. 2016, Page 7
`
`Geneoscopy Exhibit 1076, Page 7
`
`
`
`
`What Is Inside the Cologuard Collection Kit
`
`Shipping Box
`
`Sample
`Container
`
`Tube
`
`Patient
`Guide
`Instructions
`
`Bottle of Liquid
`(preservative)
`
`Bracket
`
`Sample
`Labels
`
`• The bottle of liquid contains a preservative (less than 10% EDTA in Tris buffered solution).
`• The tube contains a 10% albumin in Tris buffered detergent solution with an antimicrobial agent.
`For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` Rx Only
`
`Page 8
`
`Patent Owner's Ex. 2016, Page 8
`
`Geneoscopy Exhibit 1076, Page 8
`
`
`
`
`
`Who Should Use Cologuard?
`
`Cologuard is intended for people who are typical candidates for colorectal cancer screening,
`which include:
`• Men and women 50 years or older
`• At average risk for colorectal cancer
`
`Is Cologuard Right for You?
`Talk with your doctor about using Cologuard if any of the following apply to you:
`• A history of colorectal cancer, adenomas, or other related cancers.
`• Had a positive result from another colorectal cancer screening method within the last 6 months.
`• Been diagnosed with a condition that is associated with high risk for colorectal cancer. These
`include but are not limited to:
`o Inflammatory Bowel Disease (IBD)
`o Chronic ulcerative colitis (CUC)
`o Crohn’s disease
`o Familial adenomatous polyposis (FAP)
`o Family history of colorectal cancer
`• Been diagnosed with a relevant familial (hereditary) cancer syndrome, such as Hereditary
`non-polyposis colorectal cancer syndrome (HNPCCC or Lynch Syndrome),
`Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner’s syndrome, Turcot’s
`(or Crail’s) syndrome, Cowden’s syndrome, Juvenile Polyposis, Cronkhite-Canada syndrome,
`Neurofibromatosis, Familial Hyperplastic Polyposis.
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 9
`
`Patent Owner's Ex. 2016, Page 9
`
`Geneoscopy Exhibit 1076, Page 9
`
`
`
`Caution
`
`Caution
`
`• Do not drink the bottle of preservative liquid.
`• Do not let the liquid touch your skin or eyes.
`•
`If the liquid touches your skin or eyes, wash the area with water.
`
`Risks
`
`The risks related to using the Cologuard collection kit are low. No serious adverse events
`were reported among 10,023 people in a clinical trial.
`• Opening or closing the lids of items in the kit may be difficult for some people.
`o Be careful when opening and closing the lids to avoid the risk of hand strain.
`o Close all sample containers tightly.
`• Using this kit requires sitting down on the toilet and standing up from the toilet.
`o Have someone who can help you if needed.
`• There is a chance that a stool sample sent to the lab may have no result.
`o If this happens, you will be contacted. You may be asked to provide
`another sample.
`
`Page 10
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 10
`
`Geneoscopy Exhibit 1076, Page 10
`
`
`
`What Should I Know Before Using the Cologuard
`Collection Kit?
`
`Only remove the items you need
`to collect your sample following the
`steps in this guide.
`
`• Leave the plastic bag inside the box. The box, zippered bag and cardboard tray inside
`the bag will be used to send your sample to the lab.
`• Use the kit before the expiration date printed on the side of the box.
`• Avoid getting urine in the container when collecting your stool sample.
`• Avoid getting toilet paper or other materials in the container when collecting your
`stool sample.
`• The lab must receive samples within 3 days.
`o Collect a sample when you can ship your sample within a day of collection.
`o Make sure a holiday will not delay your shipment.
`o Review Step 8: Ship Your Sample Using UPS in this guide for detailed
`shipping information.
`• You are not required to change your diet or medications to use this screening test.
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 11
`
`Patent Owner's Ex. 2016, Page 11
`
`Geneoscopy Exhibit 1076, Page 11
`
`
`
`When Should I Not Use the Cologuard Collection Kit?
`
`Certain conditions may cause an incorrect test result or no result. Do not use this kit to collect
`a stool sample if you have:
`o Bleeding hemorrhoids
`o Bleeding cuts or wounds on your hands
`o Rectal bleeding
`o Menstrual period
`o Diarrhea
`
`Page 12
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 12
`
`Geneoscopy Exhibit 1076, Page 12
`
`
`
`Step 1: Check the Expiration Date and the Kit
`Check your kit to make sure the kit has not expired and you have all the parts of the kit.
`a. Check the expiration date on the outside
`of the box.
`b. Use the kit before the expiration date
`printed on the side of the box.
`•
`If the date has passed, do not use the kit.
`Close the box and contact Exact Sciences
`at 1-844-870-8878 for a new kit.
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 13
`
`Patent Owner's Ex. 2016, Page 13
`
`Geneoscopy Exhibit 1076, Page 13
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`
`
`Sample
`
`Guide
`
`Bracket
`
`Leave the plastic bag and gray cardboard
`insert inside the box.
`
`c. Check the items in your box and make sure
`you have the following:
`• Bracket
`• Sample container
`• Tube
`• Bottle of liquid (preservative)
`• Shipping labels (attached to top of box)
`• Sample labels
`If any items are missing from your kit,
`do not use the kit. Contact Exact Sciences
`at 1-844-870-8878 for a new kit.
`
`d. If all items are included in your kit, your kit
`is ready to use.
`
`Follow the next steps when you feel ready
`to have a bowel movement.
`
`Page 14
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 14
`
`Geneoscopy Exhibit 1076, Page 14
`
`
`
`Step 2: Prepare to Collect Stool Sample
`Follow these steps in your bathroom to set up the bracket and stool sample container.
`
`a. Decide the best time to collect a stool
`sample.
`• Follow these steps when you feel
`ready to have a bowel movement.
`• Collect your sample on a day when
`you can ship your sample to arrive
`at the lab within 3 days.
`o Ship your sample
`within a day of collection.
`o See Step 8: Ship Your Sample
`Using UPS for a shipping
`schedule.
`• Do not collect a stool sample if
`you have:
`o Bleeding hemorrhoids
`o Bleeding cuts or wounds on
`your hands
`o Rectal bleeding
`o Menstrual period
`o Diarrhea
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Page 15
`
`Patent Owner's Ex. 2016, Page 15
`
`Geneoscopy Exhibit 1076, Page 15
`
`
`
`b. Remove the bracket from the box and
`unfold the sides of the bracket
`
`c.
`
`c. Raise the toilet lid and seat.
`
`Place under
`toilet seat
`
`d.
`
`d. Place the bracket on the toilet as shown.
`• Place the bracket toward the back
`of the toilet.
`
`Page 16
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 16
`
`Geneoscopy Exhibit 1076, Page 16
`
`
`
`e.
`
`e. Lower the toilet seat onto the bracket.
`• The entire opening of the bracket
`should be visible.
`
`f. Lift the stool sample container out of
`the box and place on a hard, flat surface.
`
`g.
`
`g. Turn the container lid and unscrew it.
`
`h. Set the container lid down.
`
`i.
`
`i. Place the container into the top of
`the bracket.
`
`open
`
`Place
`into
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Page 17
`
`Patent Owner's Ex. 2016, Page 17
`
`Geneoscopy Exhibit 1076, Page 17
`
`
`
`Step 3: Collect the Stool Sample
`• Make sure you have help if you have trouble sitting and standing when using the toilet.
`
`a. Sit on the toilet and have a bowel
`movement in the container.
`• Try to keep urine from going into
`the container.
`• Do not put toilet paper or other
`items into the container.
`
`b. When your bowel movement is
`complete, stand up.
`
`Leave
`container
`open
`
`c.
`
`c. Lift the stool sample container from the
`bracket and set the container on a flat,
`stable surface.
`• Leave the container open.
`
`Page 18
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 18
`
`Geneoscopy Exhibit 1076, Page 18
`
`
`
`d.
`
`e.
`
`d. Remove the bracket from the toilet.
`• The bracket can be recycled or
`thrown in the trash.
`
`e. Finish using the bathroom if needed.
`• Follow the rest of the steps in this
`guide immediately after collecting
`your stool sample.
`
`step before you close the container.
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Page 19
`
`Patent Owner's Ex. 2016, Page 19
`
`Geneoscopy Exhibit 1076, Page 19
`
`
`
`Step 4: Scrape the Stool Sample
`
`You must scrape the stool sample with the probe to get another small sample for the
`Cologuard test.
`
`a. Lift the tube out of the box.
`
`Turn to open
`
`b.
`
`b. Turn the white tube cap and unscrew it.
`
`c. Pull the probe from the tube.
`• You may have to pull hard.
`
`d. Scrape the surface of your stool sample
`until the end of the probe has stool on it.
`• Your stool sample may look different
`from the stool sample pictured.
`
`Page 20
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 20
`
`Geneoscopy Exhibit 1076, Page 20
`
`
`
`probe
`
`close
`
`e. Place the probe back into the open end
`of the tube.
`
`f. Turn the cap to close.
`
`g. Set the tube down.
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Page 21
`
`Patent Owner's Ex. 2016, Page 21
`
`Geneoscopy Exhibit 1076, Page 21
`
`
`
`Step 5: Prepare Stool Sample Container for Shipping
`
`The stool sample must have a preservative poured onto it to make sure the lab can test it.
`Then, the container must be closed tightly for shipping.
`
`open
`
`a. Lift the bottle of liquid preservative out
`of the box.
`
`b. Hold the bottle and turn the cap to
`unscrew it.
`
`• Do not drink the liquid.
`•
`If the liquid from the bottle touches
`your skin or eyes, wash with water.
`
`Use all
`the liquid
`
`c.
`
`c. Pour all the liquid in the bottle into the
`container with the stool.
`• The empty bottle and cap can be
`recycled or thrown in the trash.
`
`Page 22
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 22
`
`Geneoscopy Exhibit 1076, Page 22
`
`
`
`d. Hold the stool sample container on
`a hard, flat surface.
`
`e. Place the lid on top of the container.
`• Make sure the lid is straight so it
`will close tightly.
`
`f. Turn the lid to tighten until it does not
`tighten anymore.
`
`e.
`
`f.
`
`Turn to
`close tight
`
`Tight seal
`Correct!
`
`Lid
`with gap
`Wrong:
`loosen and
`tighten again
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 23
`
`Patent Owner's Ex. 2016, Page 23
`
`Geneoscopy Exhibit 1076, Page 23
`
`
`
`Step 6: Label Your Samples
`
`You must label your samples to identify them. For best results, use a ballpoint pen and write
`the labels on a hard, flat surface.
`
`a.
`
`a. Find the page Label Your Samples that
`is included with this guide.
`
`b.
`
`b. Fill out both labels. Print the information
`in this order:
`• Your first name
`• Your last name
`• Your birthdate (MM/DD/YY)
`• The date you collected your stool sample
`(MM/DD/YY)
`• The time you collected your stool sample
`including AM/PM
`
`Page 24
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 24
`
`Geneoscopy Exhibit 1076, Page 24
`
`
`
`c. Peel the label away from the paper.
`
`d. Wrap one label around the tube.
`
`e. Place one label on the lid of the stool
`sample container.
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Page 25
`
`Patent Owner's Ex. 2016, Page 25
`
`Geneoscopy Exhibit 1076, Page 25
`
`
`
`Step 7: Prepare Your Samples for Shipment
`• For best results, prepare your box on a hard, flat surface.
`• When you start, you should have the zippered bag inside the box. The tray for holding
`the container and tube should be inside the bag.
`
`Tube
`
`Sample
`Container
`
`
`
`
`
`
`Shipping
`Box
`
`
`
`
`
`
`
`
`Zipper
`
`
`
`
`Zippered
`Bag
`
`
`
`
`
`
`d.
`
`a. Place the tube and container into the box.
`
`b. Fold the bag and push extra air out of
`the bag.
`• Too much air in the bag will make it
`hard to close the box.
`
`c. Slide the zipper across the top of the bag
`to close and seal the bag.
`
`d. Fold the bag until it fits inside the box.
`
`Page 26
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 26
`
`Geneoscopy Exhibit 1076, Page 26
`
`
`
`e.
`
`f.
`
`g.
`
`
`
`
`
`h.
`
`e. Fold the smaller flaps over the top of
`the box.
`
`f. Fold the long flap over the two
`smaller flaps.
`• This is the flap with the STOP sign
`printed on it.
`
`g. Peel the paper backing off the tape
`on the box lid.
`• Discard paper backing in garbage.
`
`h. Fold the box top over the other flaps
`and press down firmly to seal the box.
`
`Throw away
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 27
`
`Patent Owner's Ex. 2016, Page 27
`
`Geneoscopy Exhibit 1076, Page 27
`
`
`
`i.
`
`i. Locate the shipping label on top of
`your box.
`• Shipping labels on the box may differ.
`
`j.
`
`If the shipping label has a green tear strip,
`it must be removed.
`• Lift the left corner of the tear strip and
`pull it off.
`• Lift the bottom edge of the label and
`pull up.
`• Tear the top label off the box.
`• A new label now shows.
`• You are ready to ship your box.
`• Continue with the next step.
`
`k. If the shipping label has no green tear strip,
`you are ready to ship your box.
`
`Page 28
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 28
`
`Geneoscopy Exhibit 1076, Page 28
`
`
`
`This page intentionally left blank.
`Turn the page to continue.
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Page 29
`
`Patent Owner's Ex. 2016, Page 29
`
`Geneoscopy Exhibit 1076, Page 29
`
`
`
`Step 8: Ship Your Samples Using UPS
`
`Samples must be shipped to arrive at the lab within 3 days.
`• The lab must receive samples within 3 days for samples to be tested. The lab will
`not test samples not received in time.
`• UPS will ship your samples to arrive at the lab the next day from the day it shipped.
`• Ship your samples within a day of collection for quickest delivery to the lab.
`
`If you have questions about when to ship your samples, call Exact Sciences at 1-844-870-8878.
`
`Page 30
`
` For questions or help call Exact Sciences at 1-844-870-8878
`www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 30
`
`Geneoscopy Exhibit 1076, Page 30
`
`
`
`Storing Your Samples Before Shipment
`
`To store the samples while you plan for shipping the box:
`• Store your boxed and sealed samples at room temperature.
`• Keep the samples away from heat and direct sunlight.
`• Keep samples out of the reach of children.
`• Keep the box upright.
`
`Ways to Ship the Samples
`
`You have the following options for shipping your samples:
`• Drop off at a UPS location. Check www.ups.com for UPS drop-off locations.
`o UPS Stores
`o UPS Customer Center
`o UPS Alliance Location (For Example: Staples, Office Depot)
`o UPS Authorized Shipping Outlet
`o Any UPS Driver
`• Call UPS at 1-800-742-5877 for pick up or to find a drop off location near you
`(M-F 7:30am-12:00am, Sa 7:30am-9:00pm Eastern Standard Time).
`o You can also schedule a pick up online at www.ups.com any time.
`o Be sure to provide the tracking number shown on your prepaid return shipping
`label, which starts with 1Z.
`Once you have shipped the samples to the lab, you are finished! Your doctor will contact
`you with your result.
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 31
`
`Patent Owner's Ex. 2016, Page 31
`
`Geneoscopy Exhibit 1076, Page 31
`
`
`
`Glossary
`
`Adjunctive: A test used together with another test.
`Colon: A part of the human digestive system sometimes known as the large intestine.
`Colorectal Cancer: A disease of abnormal growths in the colon or rectum that, if left
`untreated, may spread throughout the body. Colon cancer generally develops over a
`number of years.
`Colonoscopy: A medical test where a flexible tube is placed into the colon so the surface
`of the colon can be seen by a camera. Instruments can be placed through the tube to
`remove growths found on the colon wall.
`DNA: Deoxyribonucleic acid. Changes in the stool DNA (sDNA) can show your doctor if there
`is cancer or a possibility of cancer present.
`Hemoglobin: A compound from blood. Blood or hemoglobin in the stool that cannot be
`seen by the naked eye is referred to as occult blood or occult hemoglobin.
`Neoplasia: A growth that is not normal.
`Precancerous Polyp (Adenoma): A growth on the wall of the colon that may become cancer.
`
`Page 32
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 32
`
`Geneoscopy Exhibit 1076, Page 32
`
`
`
`Symbols Used on the Cologuard Collection Kit
`
`Collection of harmonized symbols used on labeling for the kit.
`
`Lot Number
`
`
`
`
`
`
`
`Manufacturer
`
`Storage
`Temperature
`
`Contains
`Sufficient
`for (n) Tests
`
`
`
`
`
`
`
`Catalog
`Number
`
`In Vitro
`Diagnostic
`Use
`
`
`
`
`
`
`
`Expiration
`Date
`
`Caution
`
`Clinical Study Results
`Cologuard was studied in a large clinical trial to determine the effectiveness of the test.
`The trial included more than 10,000 patients at 90 sites in the US and Canada. Each person
`in the study completed Cologuard and a fecal occult blood test before having a standard
`colonoscopy. The main purpose of the study was to find out the performance of Cologuard
`for finding cancer and precancer compared to a colonoscopy.
`In the clinical study, Cologuard correctly detected 92% of colorectal cancers and 42% of
`advanced adenomas in the study population that had disease. The Cologuard test
`correctly gave a negative screening result for 87% of the study subjects that did not
`have colorectal cancer or advanced adenomas. In other words, 13% of people without
`cancer or precancer tested positive.
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Page 33
`
`Patent Owner's Ex. 2016, Page 33
`
`Geneoscopy Exhibit 1076, Page 33
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Cologuard is a trademark of Exact Sciences Corporation. Refer to www.exactsciences.com/intellectual-property/
`for additional information regarding Exact Sciences intellectual property holdings and policies.
`©2014 Exact Sciences Corporation. All rights reserved.
`
`EXACT SCIENCES CORPORATION
`441 Charmany Drive | Madison, WI 53719 | www.exactsciences.com
`
` For questions or help call Exact Sciences at 1-844-870-8878
` www.cologuardtest.com
` For Rx Only
`
`Patent Owner's Ex. 2016, Page 34
`
`Geneoscopy Exhibit 1076, Page 34
`
`
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