Atossa Personalized Medicine 際際滷s
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This document describes a breast cancer screening technology called the Mammary Aspirate Specimen Cytology Test (MASCT) developed by Atossa Genetics. The MASCT uses a reusable device to non-invasively collect nipple aspirate fluid, which contains cells that can be analyzed to detect pre-cancerous changes up to 8 years before mammography. The company plans to launch the MASCT product and an accompanying cytology analysis service in breast clinics across the US to tap into the $13 billion annual breast cancer screening market. Management aims to improve the technology and expand the types of molecular biomarkers analyzed over time to further advance breast cancer risk assessment.
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Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes.Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes. Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes. Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes.Prostate-Specific Antigen (PSA): Used in prostate cancer screening.
Cardiac Troponin: Indicates myocardial infarction.rofiling Biological Samples:
Compare samples from healthy individuals and those with diseases using advanced techniques like genomics, proteomics, and metabolomics.
2. Techniques Used:
Next-Generation Sequencing (NGS): Identifies genetic mutations (e.g., HER2/neu in breast cancer).
Mass Spectrometry (MS): Detects protein and metabolite biomarkers.
Microarray Analysis: Measures gene expression profiles.
3. Data Analysis and Validation:
Bioinformatics tools and machine learning algorithms analyze large datasets.
Validation ensures biomarker reliability (e.g., PD-L1 expression in non-small cell lung cancer).pha-Fetoprotein (AFP): Diagnose hepatocellular carcinoma.
2. Treatment Monitoring:
Bcr-Abl Transcript Levels: Monitor response to imatinib in chronic myeloid leukemia (CML).
Circulating Tumor DNA (ctDNA): Track cancer progression and treatment response.
3. Predictive Biomarkers:
EGFR Mutations: Predict response to tyrosine kinase inhibitors in lung cancer.
KRAS Mutation Status: Guide anti-EGFR therapy in colorectal cancer.
際際滷 5: Biomarkers in Personalized Medicine
1. Genomic Biomarkers:
BRCA1/BRCA2 Mutations: Assess risk of hereditary breast and ovarian cancers.
TP53 Mutations: Associated with Li-Fraumeni syndrome and various cancers.
2. Transcriptomic Biomarkers:
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Gene Expression Profiles: Classify leukemia subtypes.
3. Proteomic Biomarkers:
HER2/neu Overexpression: Indicates aggressive breast cancer.
PD-L1 Expression: Guides immunotherapy decisions in cancer.
際際滷 6: Types and Classifications of Biomarkers
1. Molecular Biomarkers:
Genetic/Genomic: BRCA1/BRCA2 mutations.
Transcriptomic: Gene expression profiles.
Proteomic: HER2/neu protein levels.
Metabolomic: Glucose levels in diabetes.
2. Functional Biomarkers:
Cardiac Troponin: Diagnoses myocardial infarction.
3. Clinical Biomarkers:
Circulating Tumor Cells (CTCs): Monitor metastatic breast cancer.
4. Biomarkers by Intended Use:
Diagnostic: PSA for prostate cancer.
Prognostic: ER status in breast cancer.
Predictive: EGFR mutations in lung cancer.
Monitoring: Bcr-Abl in CML.
際際滷 7: Biomarkers in Disease Diagnosis
1. Early Detection:
PSA Levels: Screen for prostate cancer.
Cardiac Troponin: Diagnose myocardial infarction.
2. Genomic Biomarkers:
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Prostate-Specific Antigen (PSA): Used in prostate cancer screening. Cardiac ...Hajir Fathi
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Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes.Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes. Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes. Biomarkers are measurable biological molecules (e.g., DNA, RNA, proteins, metabolites) that indicate normal or pathological processes.Prostate-Specific Antigen (PSA): Used in prostate cancer screening.
Cardiac Troponin: Indicates myocardial infarction.rofiling Biological Samples:
Compare samples from healthy individuals and those with diseases using advanced techniques like genomics, proteomics, and metabolomics.
2. Techniques Used:
Next-Generation Sequencing (NGS): Identifies genetic mutations (e.g., HER2/neu in breast cancer).
Mass Spectrometry (MS): Detects protein and metabolite biomarkers.
Microarray Analysis: Measures gene expression profiles.
3. Data Analysis and Validation:
Bioinformatics tools and machine learning algorithms analyze large datasets.
Validation ensures biomarker reliability (e.g., PD-L1 expression in non-small cell lung cancer).pha-Fetoprotein (AFP): Diagnose hepatocellular carcinoma.
2. Treatment Monitoring:
Bcr-Abl Transcript Levels: Monitor response to imatinib in chronic myeloid leukemia (CML).
Circulating Tumor DNA (ctDNA): Track cancer progression and treatment response.
3. Predictive Biomarkers:
EGFR Mutations: Predict response to tyrosine kinase inhibitors in lung cancer.
KRAS Mutation Status: Guide anti-EGFR therapy in colorectal cancer.
際際滷 5: Biomarkers in Personalized Medicine
1. Genomic Biomarkers:
BRCA1/BRCA2 Mutations: Assess risk of hereditary breast and ovarian cancers.
TP53 Mutations: Associated with Li-Fraumeni syndrome and various cancers.
2. Transcriptomic Biomarkers:
Oncotype DX: Predicts recurrence risk in breast cancer.
Gene Expression Profiles: Classify leukemia subtypes.
3. Proteomic Biomarkers:
HER2/neu Overexpression: Indicates aggressive breast cancer.
PD-L1 Expression: Guides immunotherapy decisions in cancer.
際際滷 6: Types and Classifications of Biomarkers
1. Molecular Biomarkers:
Genetic/Genomic: BRCA1/BRCA2 mutations.
Transcriptomic: Gene expression profiles.
Proteomic: HER2/neu protein levels.
Metabolomic: Glucose levels in diabetes.
2. Functional Biomarkers:
Cardiac Troponin: Diagnoses myocardial infarction.
3. Clinical Biomarkers:
Circulating Tumor Cells (CTCs): Monitor metastatic breast cancer.
4. Biomarkers by Intended Use:
Diagnostic: PSA for prostate cancer.
Prognostic: ER status in breast cancer.
Predictive: EGFR mutations in lung cancer.
Monitoring: Bcr-Abl in CML.
際際滷 7: Biomarkers in Disease Diagnosis
1. Early Detection:
PSA Levels: Screen for prostate cancer.
Cardiac Troponin: Diagnose myocardial infarction.
2. Genomic Biomarkers:
BRCA1Recover from cancer diagnosis
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This document summarizes lessons from analyzing 1,600 health news stories over 6 years. It finds that most stories fail to adequately discuss costs, quantify benefits and harms, evaluate evidence quality, and compare new options to existing ones. There is also a tendency to emphasize benefits and minimize harms. Screening stories in particular are often one-sided and promote false certainty. Overall, health journalism could be improved by providing more balanced and evidence-based reporting.SHARE: Report Back from Annual Meeting of American Association of Cancer Rese...
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This document provides an overview of cancer including its causes, diagnosis, treatment and prevention. It discusses that cancer is caused by genetic mutations that disrupt normal cell growth and can be due to factors such as viruses, radiation, chemicals and heredity. The diagnosis of cancer involves tissue biopsies, imaging tests and tumor marker tests to determine the cancer type and stage. Treatment may include surgery, radiation therapy, chemotherapy and targeted therapies to cure early stage cancer or control later stage cancer. Screening tests can help detect some cancer types early when they are more likely to be cured. Prevention strategies include avoiding risk factors, vaccinations, chemoprevention and healthy behaviors.Morphologomics - Challenges for Surgical Pathology in the Genomic Age by Dr. ...
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The document discusses the emergence of '-omics' technologies, particularly 'morphologomics', and their impact on surgical pathology and cancer diagnosis. It highlights the growing interest and clinical applicability of genomic sequencing for personalized medicine, despite challenges in cost-effectiveness and implementation. Furthermore, it addresses the recreational genomic testing industry and the implications for pathologists as genomic technologies evolve.Oncotype dx
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The document provides an overview of genomics in breast cancer and summarizes the Oncotype DX genomic assay. It discusses how the assay analyzes the expression levels of 21 genes in breast tumor tissue to provide a Recurrence Score that quantifies a patient's risk of recurrence and predicts who will benefit from chemotherapy. Clinical studies have shown the assay stratifies patients into low, intermediate, and high risk groups and identifies those unlikely to benefit from chemotherapy while high risk patients see significant reduction in recurrence with chemotherapy. The assay is recommended in clinical guidelines and widely covered by insurance.Bladder Cancer Diagnostic-Initial Team Project
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ACDS Laboratories has developed a new 3-protein biomarker for bladder cancer diagnosis using VEGF, ApoE, and IL-8. The biomarker provides high sensitivity of 90% and specificity of 97% in a study of 127 patients, outperforming current methods. It can be detected through a non-invasive urine test using ELISA, addressing the need for a simple, accurate, and cost-effective diagnostic. Economic analysis shows the biomarker could save over $200 million annually in the US through reducing invasive procedures and long-term monitoring costs compared to current protocols. Based on the strong clinical and economic value, ACDS recommends investing in developing this biomarker.READERS DIGEST 10 5 16 OBGYN Signs
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- A summary of studies showing reductions in disease incidence as vitamin D levels increase from 25 to over 60 ng/ml. Many diseases such as cancer, diabetes and heart disease showed reductions of over 30% at levels of 40 ng/ml or higher.
- Charts showing the wide range of serum vitamin D levels achieved at different daily supplemental intake amounts, based on data from over 7,000 participants. Intakes of 4000 IU/day resulted in levels from 20-120 ng/ml, demonstrating individual variability.
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- However, many women lack knowledge about breast density and its health implications, and options for screening technologies. Nearly half did not know if they had dense breasts.
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Ad
Atossa Personalized Medicine 際際滷s
- 2. The Next Generation in Womens Health SolutionsAdvancing Womens Breast Health
- 3. Patented, FDA-Cleared Breast Cancer Risk Assessment TestInexpensive, Cost Effective, Painless, Safe Adjunct to MammographyPotential to Significantly Reduce Breast Cancer The Pap Test for Breast Cancer3
- 4. Atossa Genetics Two-Pronged Medical SolutionCollect NAFDiagnoseNAFCytology & Biomarker ServicesMASCT System Product4
- 5. Atossa Genetics Two-Pronged Business ModelProduct and Service Revenue $13 Billion Annual US MarketNear-Term Launch in 2011Experienced Management5
- 6. The Breast Cancer Problem1 In 8 Lifetime Cancer Risk519,000 New Cases per YearLiterally One Death/Minute$3.8 Billion Financial Burden6
- 7. Breast Cancer Doesnt Happen OvernightTakes > 8 Years to Develop Identifying Pre-Cancerous Changes Empowers Patients & PhysiciansObtaining Samples Has Not Been Practical- Until NowDespite Shortcomings, 38.9 MM Women in U.S. Have Annual Mammograms7
- 8. Pap Test for Breast CancerBoth Cervical and Breast Cancer Develop Over About a DecadeThe Cervix Undergoes Similar Pre-Cancerous ChangesPAP Test has lowered Cervical Cancer by 74%PAP Test is Most Successful Screening Test in Medical History8
- 9. Atossa Products & ServicesSERVICES: 際際滷s Prepared and Interpreted in Atossa Laboratory; Report Prepared: Medicare: $322 per PatientPRODUCTS: Mammary Aspirate Specimen Cytology Test or (MASCT)Reusable device for collecting Nipple Aspirate Fluid (NAF), which contains cellsPump: $200Patient kit: $509
- 10. Patient Flow and ProceduresPainless,10 minute Test - No radiationMAMMOGRAPHY ORCLINICPATIENT WAITINGFOR TESTCytology report STARTMASCT SYSTEMCOLLECTS SAMPLEATOSSA LABORATORYPREPARES SLIDESSAMPLES ARE SHIPPEDFOR ANALYSIS10
- 11. Atossa Services:Patented Cytology and IHCPatient List Prices are Two-to Over Three-Times Medicare Reimbursement Rates80% NormalINITIAL ROUTINE STAINING20% HyperplasiaReflex IHC11
- 12. Clinical Utility:Over 200 papers and 20,000 WomenNIPPLE ASPIRATE FLUID CYTOLOGY AND THE GAIL MODEL FOR BREAST CANCER RISK ASSESSMENT IN A SCREENING POPULATION Jeffrey A. Tice,1 Rei Miike,2 Kelly Adduci,3 Nicholas L. Petrakis,2 Eileen King,2 and Margaret R. Wrensch2 1 Division of General Internal Medicine, Department of Medicine, 2Department of Epidemiology and Biostatistics, and 3 Cancer Center, University of California, San Francisco, San Francisco, California BREAST CANCER RISK IN WOMEN WITH ABNORMAL CYTOLOGY IN NIPPLE ASPIRATES OF BREAST FLUID M. R. Wrensch, N. L. Petrakis,R. Miike, E. B. King, J. Neuhaus, M. M. Lee (Department of Epidemiology and Biostatistics, School of Medicine), K. Chew (Cancer Center), University of California, San Francisco; M. Rhys, School of Nursing, University of California, Los Angeles THE ROLE OF NIPPLE-ASPIRATE FLUID CYTOLOGY IN BREAST-CANCER RISK SCREENING Joel Bentz, M.D., Clinical Professor of Pathology, University of Utah, Salt Lake City, UT12
- 13. Why Should a Women Have a MASCT Test?Predicts breast cancer up to 8 years in advanceMammography cannot detect pre-cancersActionable informationIncreased screening frequencyPreventive measuresMASCT is simple, quick, convenient, painless, safe (no radiation), and cost effective13
- 14. How Do You Use the Information?Step 1: Test NAF For Hyperplasia Step 2: If Present, Treat For 6 Months Step 3: Retest NAF For Treatment SuccessNo Mammography Changes33 patients 6 mo therapyBASELINE:CYTOLOGY, ADHPSA BIOMARKER = 37.5FOLLOW-UP:CYTOLOGY, IMPROVEDPSA BIOMARKER = 112Sauter et al. Breast.油16(5):489-94, 200714
- 15. MASCT Procedures & RevenueAt $372 Per Patient, Total Available Market Inthe U.S. Exceeds $13 Billion Per YearMAMMOGRAPHYCLINICMammography Clinic Demographics8600 Centers in the U.S.Each Center Provides 4500 Mammograms per Year38.9 Million Mammograms per Year in the U.S.15
- 16. All MASCT Steps Are PatentedUS Patent 6,887,210US Patent 6,889,073Mammography Clinic or officePatient waiting for testCytology report US Patent 6,887,210US Patent 6,889,073US Patent 6,889,073MASCT SystemCollects NAFATOSSA LABORATORY PREPARES SLIDESSAMPLES SHIPPED FOR ANALYSIS16
- 17. Worldwide Patent Protection:14 Issued Patents with Additional PendingCanadaEuropeJapanUnited StatesHONG KONGAustralia17
- 18. Competition:Breast Cancer ScreeningNeomatrix is a privately held company with a device that collects fluid From the breast for screening 250 machines placed Performed over 50,000 tests18
- 19. MASCT Launch CalendarQ1 2011MANUFACTURING FOR FIELD TESTING DONELABORATORY IDENTIFIED AND LEASED DONEQ2 2011FIELD TESTING BEGINSLABORATORY CLIA-REGISTRATIONQ3 2011REGIONAL ROLL-OUT IN PACIFIC NORTHWESTQ3 2012 NATIONAL ROLL-OUT19
- 20. 2nd Generation Product:Oxy-MASCT SystemAdditional NAF would be aid biomarker detectionAtossa discovered oxytocin increases NAF 10XUS Patent 5,798,226 covers oxytocin use for NAF collectionAdditional clinical trials & FDA approval needed20
- 21. 2nd Generation Services:Molecular BiomarkersMicroRNA PatternsNext Gen SequencingDNA MethylationTranscriptomeProteomicsGlycosylation
- 22. Management & Board of DirectorsSteven C. Quay, M.D., Ph.D., Chairman, CEOChristopher Benjamin, CFO Shu-Chih Chen, Ph.D., Chief Scientific OfficerMr. John Barnhart, Former Senior Walt Disney ExecutiveStephen Galli, M.D., Chairman, Pathology Dept., Stanford Medical SchoolAlexander Cross, Ph.D., Former CEO, Syntex Corporation22
- 23. 5 FDA Approved Drugs and 1 Device Invented and DevelopedSteven C. Quay, M.D., Ph.D.23
- 24. Pharmaceutical Business Experience:Patent, Development, MarketingOver $1.3 Billion In Negotiated Milestone Payments, Up-front Payments, And Other Consideration24
- 25. Princess AtossaIN 518 B.C., PRINCESS ATOSSA, WIFE OF DARIUS THE GREAT, BECAME THE FIRST WOMAN IN RECORDED HISTORY TO BE DIAGNOSED WITH BREAST CANCER. SHE WAS TREATED BY THE COURT PHYSICIAN, DEMOCEDES, BUT DIED SHORTLY THEREAFTER. ATOSSA GENETICS IS DEDICATED TO HER AND THE MILLIONS OF WOMEN WHO HAVE SUFFERED FROM THIS DREADED DISEASE.Steven C. Quay, M.D., Ph.D.Founder, Chairman, President and CEOPrincess Atossa25
- 26. The Next Generation in Womens Health SolutionsAdvancing Womens Breast HealthSteven C. Quay, MD, PhDChairman, CEO, And President4105 E Madison St, Suite 320 Seattle, WA 98112T: 206.325.6086 STEVEN.QUAY@ATOSSAGENETICS.COM26
Editor's Notes
- #12: $322 per Patient Weighted AverageCosts are under $20 per slide
- #15: Breast cancer prevention
- #21: As MASCT System biomarker tests expand the availability of additional NAF would be usefulAdministration of oxytocin 5 to 10 minutes before MASCT collection provides up to a 10-fold increase in NAFUS Patent 5,798,226, exclusively licensed to Atossa, covers the use of oxytocin for NAF collectionAdditional clinical trials and FDA approval will be required for Oxy-MASCT commercialization