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Columbia University Medical Center Sponsors Clinical Study Using Biocept’s Liquid Biopsy Platform to Evaluate Cerebrospinal Fluid of Breast Cancer Patients for Metastatic Biomarkers

Biocept, Inc., a leading commercial provider of clinically actionable liquid biopsy tests designed to improve the outcomes of cancer patients, announces that Columbia University Medical Center will conduct a study to evaluate the clinical utility of the Company’s Target Selector™ platform to diagnose leptomeningeal metastases (LM) in patients with breast cancer.  LM occurs when tumor cells gain access to cerebrospinal fluid (CSF) pathways and regrow in distant sites within the spinal cord and brain leading to neurological complications. Biocept’s liquid biopsy platform will be used to test the CSF of breast cancer patients and will be compared to standard methods for confirming the diagnosis of LM.

Biocept to Collaborate on Biopharma Company Clinical Trial by Identifying Biomarkers Found in Cerebral Spinal Fluid for Patients with Lung Cancer that has Spread to the Brain

Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer, announces a collaboration on a biopharmaceutical company clinical trial analyzing biomarkers using both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) from cerebrospinal fluid (CSF). The trial is being conducted in patients with non-small cell lung cancer (NSCLC) whose disease has spread to the brain or membranes surrounding the brain and spinal cord, known as leptomeningeal disease.

Focus Diagnostics Receives FDA Clearance for Moderate Complexity Simplexa HSV 1 & 2 Direct Molecular Test for Aiding the Diagnosis of Encephalitis

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information and services, recently announced that its Focus Diagnostics products business has received expedited FDA 510(k) clearance and CLIA moderate complexity categorization for its new Simplexa HSV 1 & 2 Direct molecular test on the 3M Integrated Cycler. The test, which is now available for purchase in the United States, is the first molecular test to be cleared by the FDA for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal fluid (CSF) from patients suspected of HSV central nervous system (CNS) infection, including encephalitis. The test uses a proprietary process that eliminates nucleic acid extraction, so clinicians can expect results within about an hour after providing a specimen for testing.

Spinal Fluid Biomarkers of AD and Brain Functional Network Integrity on Imaging Studies

Both Aß and tau pathology appear to be associated with default mode network integrity before clinical onset of Alzheimer disease (AD), according to a study by Liang Wang, M.D., and colleagues at Washington University in St. Louis, Missouri.

Accumulation of Aß and tau proteins, the pathologic hallmarks of AD, starts years before clinical onset. Pathophysiological abnormalities in the preclinical phase of AD may be detected using cerebrospinal fluid (CSF) or neuroimaging biomarkers, according to the study background.

A total of 207 older adults with normal cognition participated in the cross-sectional group study. Researchers examined the relationship between default mode network integrity and cerebrospinal fluid biomarkers of Alzheimer disease pathology in cognitively normal older individuals using resting-state functional connectivity magnetic resonance imaging.

According to the study results, decreased cerebrospinal fluid Aß42 and increased cerebrospinal fluid phosphorylated tau181 were independently associated with reduced default mode network integrity, with the most prominent decreases in functional connectivity observed between the posterior cingulate and medial temporal regions (regions of the brain associated with memory). Observed reductions in functional connectivity were unattributable to age or structural atrophy in the posterior cingulate and medial temporal areas.

Study: Cerebrospinal Fluid Aβ42, Phosphorylated Tau181, and Resting-State Functional Connectivity [JAMA Neurology]

Source: EurekAlert!

New Biomarker Could Reveal Alzheimer’s Disease Years Before Onset

A study published recently reported the identification of what may be the earliest known biomarker associated with the risk of developing Alzheimer’s disease (AD). The results suggest that this novel potential biomarker is present in cerebral spinal fluid (CSF) at least a decade before signs of dementia manifest.

“If our initial findings can be replicated by other laboratories, the results will change the way we currently think about the causes of Alzheimer’s disease,” said Dr. Ramon Trullas, research professor at the CSIC Institute of Biomedical Research of Barcelona and lead author of the study that was published in Annals of Neurology. “This discovery may enable us to search for more effective treatments that can be administered during the preclinical stage.”

Difficult Diagnosis

Alzheimer’s disease affects more than five million Americans and is the sixth leading cause of death in the United States. At present, the only way to accurately diagnose the disease is by post-mortem neuropathological analysis. The relationship of currently known biomarkers with the cause of the disease is unclear, making it nearly impossible to diagnose preclinical stages of the disease with any real certainty.

The CSIC researchers demonstrated that a decrease in the content of mitochondrial DNA (mtDNA) in CSF may be a preclinical indicator for Alzheimer’s disease; furthermore, there may be a directly causative relationship. The hypothesis is that decreased mtDNA levels in CSF reflect the diminished ability of mitochondria to power the brain’s neurons, triggering their death. The decrease in the concentration of mtDNA precedes the appearance of well-known biochemical Alzheimer’s biomarkers (the Aβ1-42, t-tau, and p-tau proteins), suggesting that the pathophysiological process of Alzheimer’s disease starts earlier than previously thought and that mtDNA depletion may be one of the earliest predictors for the disease.

In addition to enabling an investigation of the potential causal relationship of mtDNA and Alzheimer’s progression, the use of mtDNA as an index of preclinical Alzheimer’s disease provides an important advantage over previous biochemical markers: the detection of this novel nucleic acid biomarker is unhampered by the technical difficulties associated with protein detection. mtDNA can be readily quantified by real-time quantitative PCR (qPCR) or droplet digital PCR (ddPCR).

Quantitation of mtDNA

Prior to this study, researchers had not reported that circulating cell-free mtDNA could be detected in human CSF. But with this study, Dr. Trullas’ team was able to both detect and reproducibly quantitate mtDNA using qPCR, carefully optimized by adhering to the MIQE guidelines.

To validate their qPCR findings, Dr. Trullas’ team used Bio-Rad Laboratories’ QX100™ Droplet Digital™ PCR system. Unlike qPCR assays, the QX100 system provides an absolute quantification of target DNA molecules without the need for a standard curve. In addition, an important factor for their CSF analysis was that the Droplet Digital PCR system did not require sample purification to remove PCR inhibitors, as is necessary for qPCR assays.

“Droplet Digital PCR allowed us to validate our initial qPCR measurements because it provides absolute quantitation at the single-molecule level without relying on a standard curve,” said Dr. Trullas. “As the technology becomes more widely adopted, we anticipate that Droplet Digital PCR will be the future of detecting mtDNA in cerebral spinal fluid.”

Dr. Trullas hopes that other laboratories and hospitals will successfully replicate his group’s research results, confirming that reduced mtDNA levels should be investigated as a possible cause of Alzheimer’s disease. By finding a way to block this degeneration, clinicians may be able to diagnose and treat Alzheimer’s disease before symptoms appear.

Study: Low CSF concentration of mitochondrial DNA in preclinical Alzheimer’s disease [Annals of Neurology]

Source: Bio-Rad