Look beyond the core. The Mitomic Prostate Core Test from MDNA Life Sciences

Transcription

1 Look beyond the core The Mitomic Prostate Core Test from MDNA Life Sciences

2 Enhance your prostate biopsy resuts for better patient management Fase negative resuts are common during initia and foow-up biopsy procedures. You re forced to manage fase-negative patients in the same manner as those who are negative. But what if you coud determine the difference between these patients? Now you can. With the Mitomic Prostate Core Test (MPCT), a moecuar test ordered with prostate biopsy pathoogy, you can confidenty stratify and better manage patients. What is MPCT? MPCT identifies a arge-scae deetion in mitochondria DNA (mtdna) that indicates ceuar change associated with undiagnosed prostate cancer. By using biopsy tissue sampes that have aready been coected and stored at the ab, MPCT precudes the need for additiona office visits or surgeries. You can order MPCT as a refex test when you submit a biopsy for evauation or after the biopsy resuts are avaiabe. How do you use MPCT? Addressabe market Cinica response Positive biopsy outcome (30%) Patient seection PSA > 4.0 ng/m PSADT < 3 months MPCT negative outcome Patient is currenty at a ow risk of undiagnosed prostate cancer. Defer repeat biopsy and routine screening by 12 to 14 months. Negative biopsy outcome (70%) PSAV > 0.4 ng/m/year Life expectancy > 10 years ASAP HGPIN Famiy history >. MPCT positive outcome Patient is at a high risk of undiagnosed prostate cancer. A repeat saturation biopsy is recommended with presence of additiona risk factors. African American Note: Patient seection and cinica response to a positive or negative MPCT outcome is based on the feedback of an independent pane of eading U.S. uroogists and active users of MPCT.

3 How does MPCT work? With 85-percent sensitivity, MPCT detects the presence of maignant ces in normaappearing tissue via a tumor fied effect. Studies have indicated the fied effect for MPCT is gand-wide. Detect undiagnosed prostate cancer eary. The cancerization fied associated with mitochondria deetions provides a distinct moecuar signature that mtgenomic assessment can detect. Though conventiona histoogy of a biopsy sampe might not dispay evidence of maignancy, if the tissue comes from an area that is within the cancerization fied, disease onset wi be detectabe via this signature. Couping conventiona biopsy methodoogy with mtgenomic assessment to detect this cancerization fied provides vita cinica information. - Parr and Martin: Mitochondria and nucear genomics and the emergence of personaized medicine. MPCT outperforms competitors Because mtdna has an extended fied effect compared to nucear DNA, MPCT can be used for a negative biopsy patients and deivers the highest sensitivity and negative predictive vaue of a simiar tests. MPCT Sensitivity 85% Negative predictive vaue 92% Fied effect extent Cinica utiity Entire prostate A negative biopsies; requires ony 20 microns of tissue Gain an advantage in the fight against prostate cancer Be more confident in negative resuts and provide peace of mind to patients Stratify patients who are free of the disease from those with undiagnosed prostate cancer Detect undiagnosed prostate cancer eary Taior patient management for improved care Avoid causing patients added pain, anxiety, and risk from extra and potentiay unnecessary biopsies Heath economic benefits of MPCT Savings category Range of cost savings (in $US) Reduce or eiminate unnecessary screening $3,800 - $15,000 Reduce the number of unnecessary repeatbiopsy procedures $9,600 Eiminate the compications associated with unnecessary repeat biopsy procedures $2,000 Tota $15,400 - $26,600

4 MPCT mtdna deetion: Stages of discovery and vaidation The entire process of discovery and vaidation invoved 396 patients and cose to 1,700 prostate core sampes. Incuded were 143 patients with benign histoogy and 253 patients with maignant histoogy. Stage 2 invoved an externa vaidation study performed by the Nationa Institute of Standards and Technoogy under the Eary Detection Research Network of the Nationa Cancer Institute (NCI). Stage 3 was conducted within the framework of a cinica tria. The diagram beow outines the fow of work and the study popuation used in each stage of assay deveopment: MPCT predicted the outcome of the repeat biopsy with a SEN of 85% and a NPV of 92%. Genomic deetions within mitochondria begin to happen ong before traditiona histoogy can identify disease. Biochemica signatures can identify genomic deetions associated with a disease and predict its onset much earier than a pathoogist can observe a probem, thus creating a greater window of time for treatment possibiities. - Parr and Martin: Mitochondria and nucear genomics and the emergence of personaized medicine. Now you can know more from every biopsy Receive the eary insight you need to taior patient management. Request the Prostate Core Mitomic Test with your next prostate biopsy pathoogy. Learn more about this simpe and informative test at mdnaifesciences.com

5 Scientific pubications on MPCT Parr and Martin: Mitochondria and nucear genomics and the emergence of personaized medicine. Kent Froberg*, Laurence Kotz, Kerry Robinson, Jennifer Creed, Brian Reguy, Cortney Powe, Danie Kein, Andrea Maggrah, Roy Wittock, Ryan Parr. Large-scae mitochondria genome deetion as an aid for negative prostate biopsy uncertainty. Poster presented as a part of the American Uroogica Association Annua Meeting, Washington, D.C., May 14-19, *Abstract pubished in The Journa of Uroogy, Vo. 185 No. 4S, e 764, Suppement, May Ryan Parr, Jennifer Creed, Brian Reguy, Cortney Powe, Roy Wittock, Danie Kein, Andrea Maggrah, Kerry Robinson.* Large-scae mitochondria genome deetion as an aid for negative prostate biopsy uncertainty. Poster presented as part of the Society of Uroogic Oncoogy Annua Meeting, Bethesda, MD, Dec. 8-10, Parr RL, Jakupciak JP, Reguy B, and Dakubo GD. 3.4kb Mitochondria Genome Deetion Serves as a Surrogate Predictive Biomarker for Prostate Cancer in Histopathoogicay Benign Biopsy Cores. Canadian Uroogica Association Journa Robinson K, Creed J, Reguy B, Powe C, Wittock R, Kein D, et a. Accurate prediction of repeat prostate biopsy outcomes by a mitochondria DNA deetion assay. Prostate cancer and prostatic diseases. 2010;13(2): Epub 2010/01/20. Parr RL, Jakupciak JP, Birch-Machin MA, Dakubo GD.The Mitochondria Genome: A Biosensor for Eary Cancer Detection? Expert Opin Med Diagn. 2007;1(2): Maki J, Robinson K, Reguy B, Aexander J, Wittock R, Aguirre A, et a. Mitochondria genome deetion aids in the identification of fase- and true-negative prostate neede core biopsy specimens. American Journa of Cinica Pathoogy. 2008;129(1): Epub 2007/12/20. Dakubo GD, Jakupciak JP, Birch-Machin MA, Parr RL. Cinica Impications and Utiity of Fied Cancerization. Cancer Ce Internationa. 2007;7(2). Parr RL, Dakubo GD, Cranda KA, Maki J, Reguy B, Aguirre A, et a. Somatic mitochondria DNA mutations in prostate cancer and norma appearing adjacent gands in comparison to agematched prostate sampes without maignant histoogy. The Journa of Moecuar Diagnostics : JMD. 2006;8(3): Epub 2006/07/11. Parr RLM, J.; Reguy, B.; Dakubo, G.D.; Aguirre, A.; Wittock, R.; Robinson, K.; Jakupciak, J.P.;Thayer, R.E.The pseudo-mitochondria genome infuences mistakes in heteropasmy interpretation. BMC Genomics. 2006;21(7). John Mis*, Luis Martin, François Guimont, Brian Reguy, Andrew Harbotte, John Pedersen, Jennifer Creed, Ryan Parr. Large-Scae 3.4kb Mitochondria Genome Deetion is Significanty Associated with a Prostate Cancer Fied Effect. *Abstract accepted as part of the American Uroogica Association Annua Meeting, San Diego, CA, May 4-8, Learn more about the Mitomic Prostate Core Test Visit mdnaifesciences.com