have you actually studied-up or done your homework on all the literature available on AZ prescreening or testing standards - seems you need to do a little drill down 1st - great place to start:
Quick Background On LymPro
http://finance.yahoo.com/news/ambs-why-im-sti...00554.html
Amarantus is developing LymPro, a blood test for the diagnosis of Alzheimer's disease. We think there is a significant market need for a product like LymPro. The impetus of an AD diagnostic is to distinguish between patients with Alzheimer's and other degenerative dementias such as Parkinson's disease dementia (PDD) or psychosis, mild cognitive impairment, and/or age-related memory loss. A simple and economical test that can accurately and reliably do such would have a number of benefits in the clinical and commercial marketplace, including:
1) Significantly expedite diagnosis, allowing for earlier treatment in the primary practice setting. All current treatments, and most of the emerging ones, can only delay the onset or slow the progression of AD. An overwhelming number of researchers and publications point to early diagnosis as critical to extending a patient's quality of life. Diagnosis at or before the first symptoms could add years to a patient's well-being.
2) Significantly simplify the diagnosis process, allowing for meaningful economic savings to the healthcare system. The current diagnostic paradigm, known as a differential diagnosis algorithm, is a complex diagnosis of elimination. The physician starts with asking the patient or caregiver to provide a medical history and progression of symptoms, and may also make use of psychological studies and tests of the patient's sensation, cognition and motor functions. The physician may order a head CT or positron emission tomography (PET) scan, or magnetic resonance imaging (MRI) to determine if the patient shows signs of atrophy or other changes in the white matter of the brain. They may also order a magneto encephalograph (MEG) to document nonspecific changes in the brain.
These tests are expensive and not always available in rural or suburban areas of the country. PET systems are large and expensive to maintain, and almost never available at primary care practices. Reimbursement remains a challenge for unproven imagining agents and PET scans. Other diagnostic procedures, including protein assay of cerebrospinal fluid (CSF) are painful and highly invasive. A simply blood test analyzed by flow cytometry or through enzyme-linked immunosorbent assay (ELISA) would have enormous time and cost savings over the current diagnosis algorithm. It also allows the diagnosis to be performed by potentially thousands of more physicians at the primary level of care.
For example, Eli Lilly's (LLY) Amyvid costs roughly $1,600 per dose. Patients then undergo brain imaging through PET scan, which is an additional cost of another roughly $2,500 per incidence. Besides being rather expensive, Amyvid is ineffective if the patient is not experiencing memory impairment due to the buildup of amyloid plaque in the brain. This suggests that early diagnosis in high-risk patients is unlikely with Amyvid. As a result, CMS recently denied reimbursement for Amyvid. In April 2013, Lilly reinforced itscommitment to Alzheimer's diagnostics by acquiring a novel Tau tangle diagnostic program from Siemens Medical Solutions USA. The program includes two investigational PET tracers intended to image Tau (or neurofibrillary) tangles in the brain. However, similar to amyloid, there is no definitive proof that Tau tangles mean a patient has Alzheimer's, and by using PET, Lilly is further entrenching itself on an expensive and inefficient platform.
3) Improve outcomes by allowing for a more focused treatment based on the type of cognitive impairment. Accurately distinguishing between a patient with AD, PDD, and MCI should allow the physician or caregiver to tailor the treatment option specifically for the underlying disease. A patient with AD may be started on Aricept, Namenda, or Exelon, whereas a patient with PDD may be on Sinemet, Requip, Clozaril, or Seroquel. A patient with MCI or AAMI may simply be recommending taking aspirin, a multivitamin, calcium, or other over-the-county remedy to improve focus or memory.
4) Distinguish between patients for clinical trials and therapeutic development. The ability of a test to distinguish AD in a mixed MCI or AAMI population or earlier has significant implications in our view. The recent difficulties in proving that amyloid targeted treatments are effective may potentially be more a factor of the late stage of intervention rather than that the approach is flawed. Using a test to identify and then treat Alzheimer's at an early stage may be the key to making these drugs effective. It also assures the developers of new targeted therapeutics are focusing on the patients hypothesized to benefit from the proposed mechanism of action.
We point investors to the high profile failures of Pfizer / J&J's bapineuzumab in 2012 or Eli Lilly's solanezumab in 2012 or semagacestat in 2010. Elan's failures with bapineuzumab have beenwell chronicled following the phase 2 data in 2008. However, Pfizer and new partner, J&J, pushed forward in Phase 3, thinking they had identified a sub-group of patients without a gene called ApoE4 though post hoc data mining. Some 4,100 patients, 4 years and $500 million later, the phase 3 trial still failed. Despite not learning much from their failure with semagacestat in 2010, Eli Lilly's solanezumab faileda phase 3 study in Alzheimer's disease in 2012. According to the Cleveland Clinic, over 99% of Alzheimer s drugs fail clinical trials.
Quick Background On LymPro
http://finance.yahoo.com/news/ambs-why-im-sti...00554.html
Amarantus is developing LymPro, a blood test for the diagnosis of Alzheimer's disease. We think there is a significant market need for a product like LymPro. The impetus of an AD diagnostic is to distinguish between patients with Alzheimer's and other degenerative dementias such as Parkinson's disease dementia (PDD) or psychosis, mild cognitive impairment, and/or age-related memory loss. A simple and economical test that can accurately and reliably do such would have a number of benefits in the clinical and commercial marketplace, including:
1) Significantly expedite diagnosis, allowing for earlier treatment in the primary practice setting. All current treatments, and most of the emerging ones, can only delay the onset or slow the progression of AD. An overwhelming number of researchers and publications point to early diagnosis as critical to extending a patient's quality of life. Diagnosis at or before the first symptoms could add years to a patient's well-being.
2) Significantly simplify the diagnosis process, allowing for meaningful economic savings to the healthcare system. The current diagnostic paradigm, known as a differential diagnosis algorithm, is a complex diagnosis of elimination. The physician starts with asking the patient or caregiver to provide a medical history and progression of symptoms, and may also make use of psychological studies and tests of the patient's sensation, cognition and motor functions. The physician may order a head CT or positron emission tomography (PET) scan, or magnetic resonance imaging (MRI) to determine if the patient shows signs of atrophy or other changes in the white matter of the brain. They may also order a magneto encephalograph (MEG) to document nonspecific changes in the brain.
These tests are expensive and not always available in rural or suburban areas of the country. PET systems are large and expensive to maintain, and almost never available at primary care practices. Reimbursement remains a challenge for unproven imagining agents and PET scans. Other diagnostic procedures, including protein assay of cerebrospinal fluid (CSF) are painful and highly invasive. A simply blood test analyzed by flow cytometry or through enzyme-linked immunosorbent assay (ELISA) would have enormous time and cost savings over the current diagnosis algorithm. It also allows the diagnosis to be performed by potentially thousands of more physicians at the primary level of care.
For example, Eli Lilly's (LLY) Amyvid costs roughly $1,600 per dose. Patients then undergo brain imaging through PET scan, which is an additional cost of another roughly $2,500 per incidence. Besides being rather expensive, Amyvid is ineffective if the patient is not experiencing memory impairment due to the buildup of amyloid plaque in the brain. This suggests that early diagnosis in high-risk patients is unlikely with Amyvid. As a result, CMS recently denied reimbursement for Amyvid. In April 2013, Lilly reinforced itscommitment to Alzheimer's diagnostics by acquiring a novel Tau tangle diagnostic program from Siemens Medical Solutions USA. The program includes two investigational PET tracers intended to image Tau (or neurofibrillary) tangles in the brain. However, similar to amyloid, there is no definitive proof that Tau tangles mean a patient has Alzheimer's, and by using PET, Lilly is further entrenching itself on an expensive and inefficient platform.
3) Improve outcomes by allowing for a more focused treatment based on the type of cognitive impairment. Accurately distinguishing between a patient with AD, PDD, and MCI should allow the physician or caregiver to tailor the treatment option specifically for the underlying disease. A patient with AD may be started on Aricept, Namenda, or Exelon, whereas a patient with PDD may be on Sinemet, Requip, Clozaril, or Seroquel. A patient with MCI or AAMI may simply be recommending taking aspirin, a multivitamin, calcium, or other over-the-county remedy to improve focus or memory.
4) Distinguish between patients for clinical trials and therapeutic development. The ability of a test to distinguish AD in a mixed MCI or AAMI population or earlier has significant implications in our view. The recent difficulties in proving that amyloid targeted treatments are effective may potentially be more a factor of the late stage of intervention rather than that the approach is flawed. Using a test to identify and then treat Alzheimer's at an early stage may be the key to making these drugs effective. It also assures the developers of new targeted therapeutics are focusing on the patients hypothesized to benefit from the proposed mechanism of action.
We point investors to the high profile failures of Pfizer / J&J's bapineuzumab in 2012 or Eli Lilly's solanezumab in 2012 or semagacestat in 2010. Elan's failures with bapineuzumab have beenwell chronicled following the phase 2 data in 2008. However, Pfizer and new partner, J&J, pushed forward in Phase 3, thinking they had identified a sub-group of patients without a gene called ApoE4 though post hoc data mining. Some 4,100 patients, 4 years and $500 million later, the phase 3 trial still failed. Despite not learning much from their failure with semagacestat in 2010, Eli Lilly's solanezumab faileda phase 3 study in Alzheimer's disease in 2012. According to the Cleveland Clinic, over 99% of Alzheimer s drugs fail clinical trials.
