Академический Документы
Профессиональный Документы
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Dx
Medical Value
Dx
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4.
to Cure
Personalized Medicine: Targeted biologics, chemotherapy, and radiation
Dx: Precision Diagnostics
Curable
Antiviral HIV/AIDS
erapies
Curable
Statins
Curable
Dx: Biomarkers
Curable
Infectious Disease
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Today
Diagnostics
In Vitro Diagnostic Tests InVivo Diagnostic Tests
Tests that assess health status inside of the body or measure body functions by testing samples taken from inside the body Examples: Pregnancy test Blood chemistry Cholesterol test Glucose monitoring PSA Pap smear
Tests that assess health status inside of the body or measure body functions by testing outside of the body Examples: X-ray Temperature Blood pressure screening Ultrasound MRI Heart rate monitor
Screening
Diagnosis
Therapy Selection Used to predict efficacy or safety response to specific treatments Do not waste unproductive therapy
Monitoring Recurrence monitoring Monitoring for treatment efficacy Control disease progression with changes in treatment
Diagnostic test Applied to to complement high-risk traditional risk patients factors to identify disease early Nip disease in the bud with early treatment
Used for Assess severity definitive and/or risk of diagnosis and recurrence general cancer Inform adjuvant typing chemo decision Refer to the appropriate specialist Determine whether treatment is necessary
HIV is an extraordinary example of in vitro diagnostic evolution over a 30-year period. Upon delivering a diagnosis, a patients doctor must choose from over 20 different antiretroviral agents, representing 6 unique drug classes. Advanced molecular techniques are now used to predict how individual patients will respond to specific therapies, thus increasing the odds of survival. After beginning antiretroviral therapy (ART), patients are routinely monitored with standard and ultrasensitive blood tests every 34 months to assess viral load and confirm ongoing viral suppression. This new standard of care has extended the overall quality of life and the average life expectancy of newly diagnosed HIV patients by 2025 years. As the diagnostics industry continues to advance, better detection and testing mechanisms empower the medical community to reduce HIVs impact on public health.
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1983-84 Isolation of virus
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2000
1996 FDA approves first viral load testing that measures HIV in the blood, specifically the number of copies of viral RNA per one mL of blood
2010
HIV diagnostics now span entire spectrum of disease management, from screening to diagnosis to treatment selection to monitoring
1992 FDA licenses first rapid HIV test for diagnosis of HIV
AMA recommends resistance testing to help determine a patients initial antiretroviral regimen only if there are factors that indicate an increased risk for resistance
In vivo diagnostics
In vivo diagnostics support a broad spectrum of healthcare activities, from taking a patients vital signs to imaging and monitoring solid tumors. In vivo diagnostics provide physicians with a relatively non-invasive way to obtain information about an individuals condition. While some in vivo diagnostics continue to support the fundamentals of patient care, others are accelerating to provide exciting insights to previously unexplained conditions, including a host of neurological disorders. The high societal and economic cost of such conditions create a heightened sense of urgency around the development and adoption of these diagnostics. Functional Magnetic Resonance Imaging (fMRI) is a notable example of in vivo diagnostic advancement. fMRI is a technique that leverages traditional MRI technology to visualize blood flow in the brain in order to detect and measure areas of activity. MRI itself was developed from the Nobel-prize winning work of two American researchers specializing in nuclear magnetic resonance (NMR). Over the last decade, fMRI has become the preferred diagnostic method to determine how normal, diseased, or injured brains are functioning.1 This technology has contributed to our preliminary understanding of critical brain functions including thought, speech, movement, and sensation by enabling us to determine which parts of the brain are responsible for them. fMRI is also used in clinical settings to assess the potential risks of surgery and other invasive brain treatments. Physicians perform fMRI to help assess the effects of stroke, trauma, or degenerative diseases (such as Alzheimers) on brain function. It is also employed to monitor the growth and function of brain tumors, and the impact of radiation therapy and other surgical brain treatments. Given the staggering global scale and toll that brain disorders represent, it is critical that we pursue further advancements and innovations in this field.
Today, researchers are harnessing the latest developments in genomics, proteomics, epigenetics, and metabolomics to develop advanced tests that utilize both in vitro and in vivo technologies. The combined power of these diagnostics will give providers unprecedented access to precise, personal information about a patients health, reducing healthcare costs and improving clinical outcomes.
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Clinical laboratories Clinical laboratories include independent clinical labs, hospital labs, and physician-office labs that provide a suite of diagnostic services to support clinical decisionmaking. Over 5,000 independent clinical laboratories exist in the US, with Quest Diagnostics and LabCorp accounting for nearly half of independent clinical lab revenues.5 Diagnostic innovators Diagnostic innovators are largely early-stage companies using cutting-edge technologies and research to solve new problems in diagnostics. Innovators of molecular diagnostics, protein diagnostics, sequencing techniques, nanotechnology, and algorithm development comprise this segment (e.g. Aureon Biosciences, Genomic Health, Sequenom, T2 Biosystems). IVD companies IVD companies are generally more established than diagnostic innovators and engage more actively with providers, labs, or consumers. IVD companies include those involved in point-of-care diagnostics, clinical chemistry, immunodiagnostics, molecular diagnostics, hematology, and urinalysis (e.g. Abbott, Danaher/ Beckman, GenProbe, Roche Diagnostics). Imaging companies Imaging companies include those specializing in CT, MRI, Molecular Imaging, Ultrasound, and X-Ray (e.g. Hologic, GE Healthcare, Philips, Siemens). Life science tools developers Life science tools companies provide the platforms, content, or services to accelerate scientific advancement, and support the research, development, and production of diagnostics (e.g. Illumina, Life Technologies, PerkinElmer, Qiagen).
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Between 1988 and 2010 the human genome sequencing projects and associated research and industry activity directly and indirectly generated U.S. economic output Personal income for Americans $796B in U.S. economic output $244B in personal income for Americans
In 2010 alone, the human genome sequencing projects and associated research and industry activity directly and indirectly generated: $67B in U.S. economic output $20B in personal income for Americans 310,000 jobs
Employment opportunities
Personalized medicine
The promise of personalized medicine is the right treatment, for the right patient, at the right time. In order to deliver on this promise, a robust diagnostics industry must provide the information necessary for physicians and patients to determine, in concert, which treatment will be most beneficial to the patient. Personalized diagnostics can accurately diagnose a disease at its outset, identify the treatment that is likely to be most effective, with the fewest unwanted side effects, and monitor and adjust that treatment to optimize health outcomes. For patients and their physicians, personalized medicine offers more efficient and effective care.
About DxInsights
DxInsights was founded by industry executives Mara Aspinall from Ventana/Roche and Kristin Pothier from Health Advances, and co-founded by Hathaway Russell from Foley Hoag, and Terri Clevenger from Continuum Health. Why what we do is important We founded DxInsights because we identified the critical need for a non-lobbying organization devoted to educating stakeholders on the positive impact precision diagnostics can have on patient outcomes in our nations healthcare communities. For more information, please visit our website at www.dxinsights.net
References:
1. Pothier, K; Gustavsen, G, Philips, K. Reimbursement Landscape for Novel Diagnostics: Current Limitations, Real-world Impact, Proposed solutions. Biotechnology Industry Organization, January 2011. Radiological Society of North America and American College of Radiology. Functional MR Imaging - Brain Retrieved October 4, 2011, from radiologyinfo.org/en/ info.cfm?pg=fmribrain Sources: Boston Biomedical Consultants; IMS Health (3/20/07 press release); William Blair and Company; Easton Associates LLC Based on a 12-year forecast of average 9.6% annual growth. A total of five separate annual growth claims were averaged across industry segments and ranged from 6% to 17.1%. census.gov/econ/industry/def/d325413.htm First Research Medical & Imaging Laboratories (March 2010), IBISWorld Diagnostic & Medical Laboratories (March 2010). A keyword search for the term diagnostic was performed using the medical device search engine at: accessdata.fda. gov/scripts/cdrh/cfdocs/cfivd/index.cfm Battelle Memorial Institute. Economic Impact of the Human Genome Project 2011 White Paper. battelle.org/ publications/humangenomeproject.pdf PwC, HealthCast: The Customization of diagnosis, care and cure. March 2010.
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10. Pothier, K; Gustavsen, G, Philips, K. Reimbursement Landscape for Novel Diagnostics: Current Limitations, Real-world Impact, Proposed solutions. Biotechnology Industry Organization, January 2011. 11. Centers for Disease and Control Prevention. Chronic Disease Prevention and Health Promotion cdc.gov/ chronicdisease/index.htm 12. Reuters. Chronic Disease to cost $47 Trillion by 2030: WEF. reuters.com/article/2011/09/18/us-diseasechronic-costs-idUSTRE78H2IY20110918