News from the diagnostic testing experts

1. Feature

1.1. Sept '13 National Prostate Cancer Awareness Month

1.1.1. http://www.whitehouse.gov/the-press-office/2013/08/30/presidential-proclamation-national-prostate-cancer-awareness-month-2013

1.2. Oct '13 Breast Cancer Awareness

1.3. The magnitude of Breast and Prostate Cancer is so big that others are being affected that are free and clear of the disease.

1.4. “because of a mislabeled tissue sample that led to a misdiagnosis, Darrie Eason had both of her breasts removed to save her from a cancer that she never had.”

1.5. Breast cancer is the second most common cancer in women in the United States, and 1.6 million biopsies are done per year, according to Kenler. Read more: http://www.foxnews.com/health/2013/07/12/dna-test-helps-doctors-avoid-false-positive-cancer-diagnoses/#ixzz2dlZ9albA

2. In the News

2.1. (recent WSJ article, lab video)

2.2. http://www.foxnews.com/health/2013/07/12/dna-test-helps-doctors-avoid-false-positive-cancer-diagnoses/

3. Introducing

3.1. New Kit: Biopsy Speciman Kit (BS).This kit was designed as a customer driven request . . . they want to be able to use Know Error throughout all of their patient base.

3.2. Lab requested tests -this is a big focus for the company right now. Want to create awareness. A little different. Uses the KnowError System but in a different way. A woman had a mastectomy by mistake. When this stuff happens it is catastrophic. They believe there is a mistake in the lab, and they start googling who can help them. We have a kit designed just for that. Speciman Source Verification Kit. Reality for this particular feature - a breast surgeon is using know error in her office. they are at a tumor board. An office may have adopted Know Error, but all the physicians may not be using it.

3.3. Know Error for Breast Cancer

3.4. Know Error for Prostate Cancer: http://knowerror.com/biopsy-types/breast/

4. Case studies and stories "Evidence of Errors"

4.1. Prostate Cancer Misdiagnosis Identified by DNA Specimen Provenance Assignment Testing In this case, prospective use of the know error® system identified a prostate cancer misdiagnosis caused by a biopsy sample misidentification. Proper identity was assigned to the transposed specimens before any inappropriate treatment took place for either patient. Read the full case. | PDF (352KB) - See more at: http://knowerror.com/resources/case-studies/#sthash.4avT2OQz.dpuf

4.2. DNA Testing Confirms Identity of Transposed Breast Specimens After a female patient underwent a partial mastectomy as treatment for invasive ductal carcinoma, the pathologist discovered there were no cancer cells present in her extracted breast tissue. Know Error was consulted to investigate the situation and help determine whether the patient actually had cancer. Read the full case. | PDF (311KB) - See more at: http://knowerror.com/resources/case-studies/#sthash.4avT2OQz.dpuf

4.3. Biopsy Switch Results in Removal of Patient’s Healthy Breast - See more at: http://knowerror.com/biopsy-switch-results-in-removal-of-patients-healthy-breast/#sthash.DgpVWPaV.dpuf

4.4. Switched Prostate Tissue Samples Resulted in Unnecessary Surgery and Medical Malpractice Award - See more at: http://knowerror.com/switched-prostate-tissues-samples-resulted-in-unneccesary-surgery-and-medical-malpractice-claim/#sthash.2djrrc9f.dpuf

4.5. Pathology Error Leads to Unnecessary Lumpectomy and Removal of Lymph Nodes in Healthy Patient - See more at: http://knowerror.com/pathology-error-leads-to-unnecessary-lumpectomy-and-removal-of-lymph-nodes-in-healthy-patient/#sthash.xK7Icc2L.dpuf

4.6. Biopsy Misidentification #8 on CNN’s list of 25 Shocking Medical Mistakes - See more at: http://knowerror.com/biopsy-misidentification-8-on-cnns-list-of-25-shocking-medical-mistakes/#sthash.B4ILNwDX.dpuf

5. Product reviews

6. A question and answer section that addresses common questions

7. ⁃ Who we are ⁃ Our Story, maybe this is the CSI Story (they may want to write this) ⁃ Your Representatives (find the rep in your area; show map) ⁃ CSI Story (A story instead of a corner.) - not a priority. It's a nice to have, but not a priority. ⁃ Share knowledge, and then drive them to a page where they can express their interest in partnering with Know Error. We are happy to partner with your lab. We can make sure that your tests are accurate. ⁃ Have contracts with LA PD and are one of the best accredited CSI labs in the country ⁃ Credibility and differentiator Kits: new and existing

7.1. http://www.forbes.com/sites/georgebradt/2013/06/12/your-next-business-challenge-solve-a-problem-shared-by-many/

8. Statistics and/or infographics

8.1. Total # of patients we have protected (everyone that has been swabbed). To provide context of the #….how far have we come.

8.2. 3.5%* of biopsy samples may be transposed or contaminated with specimens from another patient - See more at: http://knowerror.com/patients-2/breast-biopsy-patients/#sthash.DIql9rLG.dpuf

8.3. This is a result of the complex diagnostic testing cycle, which consists of nearly 20 steps and several medical professionals working in different locations. - See more at: http://knowerror.com/patients-2/breast-biopsy-patients/#sthash.DIql9rLG.dpuf

8.4. three to five percent of specimens taken each year are defective in some way - See more at: http://knowerror.com/clinical-evidence/error-rate-data/#sthash.W43kPl3I.dpuf (WSJ)

8.5. Published in the American Journal of Clinical Pathology, the study documented the rate of occult SPC occurrence through prospective analysis of approximately 13,000 prostate biopsies performed as part of routine clinical practice. Results indicated that up to 3.5% of specimens being evaluated may not belong exclusively to the patient being diagnosed. - See more at: http://knowerror.com/clinical-evidence/error-rate-data/#sthash.E58jFtl7.dpuf

8.6. A 3.5% error rate indicates that approximately 56,000 biopsies may be subject to a Specimen Provenance Complication which could lead to a cancer diagnosis being assigned to the wrong patient. - See more at: http://knowerror.com/clinical-evidence/error-rate-data/#sthash.E58jFtl7.dpuf

9. Interviews

10. Dr. Bush Tips or "Cutting Down On Errors"