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BioTechne Receives Favorable Local Coverage Decision for Its ExoDx Prostate (Intel Score) (EPI) Liquid Biopsy Test; Over 60 Million Medicare Beneficiaries Will Be Covered for the Non-Invasive Test Used for Early Detection

On October 10, 2019, Bio-Techne Corporation (NASDAQ:TECH) today announced that the Medicare Administrative Contractor (MAC) National Government Services, Inc. issued a final Local Coverage Decision (LCD) covering the ExoDx Prostate(IntelliScore) – EPI – test for men who are being considered for an initial prostate biopsy. The decision is effective for tests administered on or after December 1, 2019. Following the LCD finalization, more than 60 million Medicare beneficiaries will now be covered for the EPI test effective December 1, 2019. The EPI test is a non-invasive, non-DRE requiring, urine-based, liquid biopsy test intended for men 50 years of age and older who have an elevated Prostate Specific Antigen (PSA) level between 2 – 10 ng/mL and who are being considered for a prostate biopsy. This liquid biopsy test recently received FDA Breakthrough Designation and is included in the NCCN guidelines for early detection in men for both initial and repeat biopsy. It is performed by Exosome Diagnostics, a Bio-Techne brand, in the CLIA-, ISO-, and NY-certified laboratory located in Waltham, Massachusetts, which has processed over 30,000 patient tests to date. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result. "It's been an extraordinary year for our ExosomeDx platform," commented Chuck Kummeth, Chief Executive Officer of Bio-Techne. "To achieve the NCCN guideline status after two remarkable patient studies was a great success for the ExosomeDx team and the company but attaining FDA breakthrough status was a testament to the strong promise this technology platform can bring to diagnosing cancer.

Deep Brain Stimulation (DBS) of Specific Brain Area Offers Powerful Anti-Depressant Effect Sustained Over Long Time in Those with Treatment-Resistant Depression

A study published online on Friday, October 4, 2019 in the American Journal of Psychiatry found that deep brain stimulation (DBS) of an area in the brain called the subcallosal cingulate (SCC) provides a robust anti-depressant effect that is sustained over a long period of time in patients with treatment-resistant depression--the most severely depressed patients who have not responded to other treatments. The article is titled “Long-Term Outcomes of Subcallosal Cingulate Deep Brain Stimulation for Treatment-Resistant Depression.” The long-term data presented in this study, conducted at Emory University and led by Helen S. Mayberg (photo), MD, now Professor of Neurology, Neurosurgery, Psychiatry, and Neuroscience, and Founding Director of the Nash Family Center for Advanced Circuit Therapeutics at the Icahn School of Medicine at Mount Sinai in New York City, validates earlier work conducted by the research team and lays the foundation for additional studies to refine and optimize DBS for these patients. Deep brain stimulation, currently approved by the U.S. Food and Drug Administration to treat essential tremor, Parkinson's disease, epilepsy, and obsessive-compulsive disorder, is a neurosurgical procedure involving the placement of a neurostimulator (sometimes referred to as a "brain pacemaker"), which sends high-frequency electrical impulses through implanted electrodes deep in the brain to specific brain areas responsible for the symptoms of each disorder. Dr. Mayberg led the first trial of DBS of the subcallosal cingulate white matter, known as Brodmann Area 25, for treatment-resistant depression patients in 2005, demonstrating that it could have clinical benefit.

Solitary Chemosensory Cells (SCCs) in Gums Protect Against Periodontitis, According to New Results from Monell Chemical Sciences Center; SSCs in Mice Express Taste Receptors & Downstream Coupling Protein (Gustducin) Affecting Microbiome in Mouth

Newly discovered chemical-sensing cells in the gums protect the mouth by standing guard against infections that damage soft tissue and destroy the bone that supports the teeth, according to a report from researchers at the Monell Chemical Senses Center and colleagues from China. Their results are described in an open-access article published online on October 3, 2019 in Nature Communications ( The article is titled “Gingival Solitary Chemosensory Cells Are Immune Sentinels for Periodontitis.” With the help of bitter taste receptors that also detect byproducts from harmful bacteria, these special gum cells trigger the immune system to control the amount and type of bacteria in the mouth and could one day lead to personalized dental treatments against gum disease. Periodontitis is a serious gum disorder induced by an imbalance in the bacteria and other microorganisms of the mouth (the oral microbiome). It is the sixth-most-prevalent infectious disease and the most common cause of tooth loss worldwide. Monell Center Director and President Robert Margolskee, MD, PhD and Monell Center cell biologist Marco Tizzano, PhD, along with colleagues from Sichuan University in China, found that the newly identified cells, known as solitary chemosensory cells (SCCs), are present in the gums of mice. There, these cells express several types of taste receptors along with a downstream coupling protein called gustducin. SCCs are taste-like chemical detectors that sense irritants and bacteria, and biologists have found them throughout the gut, urinary tract, nasal cavities, and now in the gums. "These sensory cells may provide a new approach for personalized treatment of periodontitis by harnessing a person's own innate immune system to regulate their oral microbiome," said Dr. Margolskee.

New Treatment Significantly Improves Survival in Women Newly Diagnosed with Advanced Ovarian Cancer; International Study Shows Niraparib (PARP Inhibitor) Administration After Chemotherapy Reduces Risk of Relapse or Death by Nearly 40%

An international study demonstrates that, administering niraparib after conventional chemotherapy treatment in patients newly diagnosed with advanced ovarian cancer, improves their progression-free survival, and reduces their risk of relapse or death from this disease. The primary investigator of this study is Dr. Antonio González Martín, (Co-Director of Clinica Universidad de Navarra (Spain), and president of the Spanish Ovarian Cancer Research Group (GEICO). The New England Journal of Medicine published the research online on September 28, 2019. The NEJM article is titled “Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.” "We evaluated in this study the benefits of using niraparib after standard treatment of ovarian cancer based on chemotherapy after surgery. With this new therapeutic approach, we have observed a significant improvement in patient progression-free survival and a reduction of almost 40% of their risk of relapse,”says Dr. González Martín, first author of the article. Ovarian cancer is diagnosed every year in approximately 205,000 women worldwide, and is the fifth leading cause of cancer death in women in Europe. It is usually diagnosed between 45 and 75 years, although there is a significant number of patients from 30 years. It is the gynecological tumor that causes more deaths because most patients are diagnosed in an advanced stage of the disease, given the absence of early diagnostic techniques. In turn, up to 80% of those affected by advanced ovarian cancer relapse after treatment with surgery and chemotherapy. "This research arises from the need to look for new strategies and alternative therapies that increase the survival of patients with this disease," says an expert.

Interim Results of Phase 3 Trial Show Immune Therapy Eliminates Tumor Cells in Early Triple-Negative Breast Cancer; Combination of Anti-PD-1 Monoclonal Antibody Pembrolizumab Plus Chemotherapy Could Become A Standard of Care If Approved, Expert Says

Immune therapy added to chemotherapy improves pathological complete response in patients with early triple-negative breast cancer, according to late-breaking interim results from the KEYNOTE-522 trial presented at the European Society for Medical Oncology (EMSO) Congress 2019 in Barcelona, Spain ( (September 27-October 1). Interim results from the KEYNOTE-522 trial interim were presented by study first author Professor Peter Schmid, Barts Cancer Institute, Queen Mary University of London, UK, during the Presidential Symposium II on September 29, 2019, and published in Annals of Oncology, Volume 30, Supplement 5, October 2019. The title of the results presentation was “LBA8_PR 'KEYNOTE-522: Phase 3 Study of Pembrolizumab (Pembro) + Chemotherapy (Chemo) vs Placebo (Pbo) + Chemo As Neoadjuvant Treatment, Followed by Pembro vs Pbo As Adjuvant Treatment for Early Triple-Negative Breast Cancer (TNBC).” The interim results from the study, which is the first phase III trial of immunotherapy in early breast cancer, also indicated an improvement in event-free survival. "The data suggest that the improved pathological complete response with pembrolizumab translates into fewer recurrences," said Professor Schmid. Triple-negative breast cancer is the most aggressive sub-type of breast cancer and more often affects young women. Patients typically receive chemotherapy, followed by surgery to remove the tumor. This provides the best chance of pathological complete response, meaning no cancerous cells remaining on the resected tumor. Women with a pathological complete response have an 85-90% likelihood of being cured, while those with residual viable tumor tissue have a 40-50% probability of recurrence, which often occurs within three years.

Low-Cost Electronic Device May Reverse Early Stages of Pattern Baldness; Small, Wearable Device “Wakes Up” Dormant Hair Follicles, Restores Hair Growth; Device Developed by Engineers at UW-Madison

Reversing baldness could someday be as easy as wearing a hat, thanks to a noninvasive, low-cost hair-growth-stimulating technology developed by engineers at the University of Wisconsin (UW)–Madison. “I think this will be a very practical solution to hair regeneration,” says Xudong Wang, PhD, a Professor of Materials Science and Engineering at the University of Wisconsin (UW)–Madison. Dr. Wang and colleagues published a description of the technology in the journal ACS Nano on September 10, 2019. The article is titled “Self-Activated Electrical Stimulation for Effective Hair Regeneration via a Wearable Omnidirectional Pulse Generator. Based on devices that gather energy from a body’s day-to-day motion, the hair-growth technology stimulates the skin with gentle, low-frequency electric pulses, which coax dormant follicles to reactivate hair production. The devices don’t cause hair follicles to sprout anew in smooth skin. Instead, they reactivate hair-producing structures that have gone dormant. That means they could be used as an intervention for people in the early stages of pattern baldness, but they wouldn’t bestow cascading tresses to someone who has been completely bald for several years. Because the devices are powered by the movement of the wearer, they don’t require a bulky battery pack or complicated electronics. In fact, they’re so low-profile that they could be discreetly worn underneath the crown of an everyday baseball cap. Dr. Wang is a world expert in the design and creation of energy-harvesting devices. He has pioneered electric bandages that stimulate wound-healing and a weight-loss implant that uses gentle electricity to trick the stomach into feeling full.

NCI Awards $1.86 Million Two-Year Contract to Aethlon Medical for Developing Device for Isolating Exosomes; Aethlon to Collaborate with U of Pittsburgh and Mass General on Project

On September 16, 2019, Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health, announced that the National Cancer Institute (NCI) has awarded the Company an SBIR Phase 2 contract for Topic 359, a solicitation entitled "Technologies for Differential Isolation of Exosomes and Oncosomes." This solicitation prioritized the advancement of technologies for isolating exosomes from biofluids for applications in oncology research and clinical care. This contract will be funded with Federal funds from the NCI, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N91019C00042. Exosomes are nanoparticles that are abundantly released from cancer cells and carry the complement of a tumor's genetic and protein cargo, making them important targets for non-invasive liquid biopsies in cancer. Aethlon is actively developing assays in this area through its majority-owned subsidiary, Exosome Sciences, Inc. However, there remains a need for high-throughput and selective technologies which isolate exosomes from various bodily fluids that could be adopted in clinical workflows. A technology that resolves the bottleneck in methods for obtaining pure populations of exosomes is anticipated to have wide applicability to be paired with downstream genomic sequencing, proteomic profiling tests, and, potentially, for the development of therapeutic products.

Southern California’s Hoag Hospital to Study Unique Early Disease Markers (Exosomes) for Cancer Detection and Management in Those at High Genetic Risk of Cancer; Hospital Will Collaborate with Exosome Sciences and Aethlon Medical

On Septembr 24, 2019, Hoag Memorial Hospital Presbyterian, in Orange County, California, announced the start of a research study to identify and characterize potential early disease markers for cancer diagnostics, cancer progression, and treatment resistance. In partnership with Exosome Sciences (, a subsidiary of Aethlon Medical, Inc. (Nasdaq: AEMD) (, scientists will study exosomes in cancer patients and individuals at high genetic risk for cancer ( Exosomes are nanoparticles that are abundantly released from cancer cells and can provide a snapshot of a tumor’s genetic and protein cargo, making them important targets for non-invasive liquid biopsies in cancer. “Liquid biopsies have the potential to facilitate the early detection of cancer and the assessment of the efficacy of potential treatments in real time. This may prove to be a critical tool in our ongoing efforts to help patients with cancer,” said Michael Demeure, MD, Program Director of Precision Medicine at Hoag ( and the principal investigator on the study at Hoag. “Hoag has an active Hereditary Cancer Program ( that supports a number of individuals and families at high risk of developing cancer and is committed to achieving breakthroughs in the detection of cancer at its earliest possible and most treatable stage.” “Liquid biopsies are a rapidly developing field of non-invasive tests for patients with and at risk for cancer,” said Timothy Rodell, MD, CEO of Exosome Sciences and Aethlon Medical, Inc.

UK Launches Project to Conduct Whole-Genome Sequencing of 500,000 Genomes Accumulated in UK BioBank; Work May Provide Increased Understanding of Diseases That May Fuel Development of New Treatments and Enable Possible Cures

A new ground-breaking project in the fight against life-threatening illnesses was launched on September 11, 2019 by the UK. The £200 million (~250 million) whole-genome sequencing project is being created, forming a partnership of pharmaceutical firms and health experts that will examine and sequence the genetic code of approximately 500,000 volunteers at the UK Biobank, based in Stockport, UK. UK Prime Minister Boris Johnson said: “Britain has a proud history of putting itself at the heart of international collaboration and discovery. Over 60 years ago, we saw the discovery of DNA in Cambridge by a team of international researchers and today we are going even further. Now, we are bringing together experts from around the globe to work in the UK on the world’s largest genetics research project, set to help us better treat life-threatening illnesses and ultimately save lives. Breakthroughs of this kind wouldn’t be possible without being open to the brightest and the best from across the globe to study and work in the UK. That’s why we’re unveiling a new route for international students to unlock their potential and start their careers in the UK.” Genomics research has the potential to create a genuinely predictive, more personalized healthcare system and the UK has a clear desire to seize the opportunities that research in this area offers, which is why the government has committed to carrying out five million analyses of DNA by 2024. The new project aims to improve health through genetic research, improve the prevention, diagnosis, and treatment of a wide range of serious and life-threatening illnesses including cancer, heart diseases, diabetes, arthritis, and dementia.

Cause of Rare, Fatal Disorder (Krabbe Disease) in Young Children Pinpointed; Proof-of-Concept Drug Therapy Benefits Mouse Model of Disease

Scientists at Washington University School of Medicine in St. Louis appear to have solved a decades-long mystery regarding the precise biochemical pathway leading to a fatal genetic disorder in children that results in seizures, developmental regression and death, usually around age 3. Studying a mouse model with the same human illness -- called Krabbe disease -- the researchers also identified a possible therapeutic strategy. The research was published online on September 16, 2019 in PNAS. The article is titled “Genetic Ablation of Acid Ceramidase In Krabbe Disease Confirms the Psychosine Hypothesis and Identifies a New Therapeutic Target.” Patients with infantile globoid cell leukodystrophy, also known as Krabbe disease, gradually lose the protective covering that insulates axons, the wiring of the nervous system. The rare condition -- affecting approximately 1 in 100,000 births -- is typically diagnosed before age 1 and progresses rapidly. Scientists have long suspected that nerve insulation is destroyed in this disorder because of a buildup of a toxic compound called psychosine. Patients with the inherited disorder are missing an important protein involved in breaking down psychosine. But the source of psychosine in Krabbe disease has been elusive, making the problem impossible to correct. "Krabbe disease in infancy is invariably fatal," said senior author Mark S. Sands, PhD, a Professor of Medicine. "It's a heartbreaking neurodegenerative disease first described more than a century ago, but we still have no effective treatments. For almost 50 years, we have assumed the psychosine hypothesis was correct -- that a toxic buildup of psychosine is the cause of all the problems. But we've never been able to prove it." Surprisingly, Dr.

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