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Audio Tone Therapy Shown to Relieve Insomnia

Asleep at the wheel

(Lechon Kirb, Unsplash.com)

27 Jan. 2023. Clinical trial findings show an electronic system that reads brain waves and feeds back personalized audio tones helps people with insomnia achieve better sleep. Results of the trial conducted by neuroscientists at Wake Forest University medical school in Winston-Salem, North Carolina appear in the 18 Jan. 2023 issue of the journal Global Advances in Integrative Medicine and Health.

Insomnia, as noted by the authors, is a continuing public health problem that shows up in absenteeism from work and school, reduced work productivity, greater risk of accidents, and higher health care costs. In addition, people with insomnia are also more likely to experience heart, metabolic, and neurological malfunctions contributing to higher risk of death. Treatments for insomnia such as cognitive behavioral therapy and some drugs are available, but the authors indicate these therapies can have limited efficacy and require extended periods of time, and in the case of drugs, undesirable adverse effects. In addition, insomnia may also be an indicator of reduced functioning of the autonomic nervous system that regulates involuntary physiological processes, such as heart rate, blood pressure, and respiration.

The team led by Charles Tegeler, chair of neurology at Wake Forest medical school, assessed an electronic therapy for insomnia called Cereset Research with Standard Operating Procedures. The Cereset techniques are an updated form of high-resolution, relational, resonance-based electroencephalic mirroring, or Hirrem, a non-invasive technique for addressing neurological disorders. With Hirrem, sensors are attached to the scalp, first to identify imbalances in brain waves contributing to the disorder, then later to respond to those imbalances with software-generated audio tones heard through headphones to recalibrate and rebalance those signals.

Tegeler and Wake Forest have studied Hirrem for a number of years. In Dec. 2017, Science & Enterprise reported on a study of Hirrem as a therapy for post-traumatic stress disorder or PTSD, finding the treatments reduced PTSD symptoms in current and former military personnel for six months. The company Cereset LLC — formerly Brain State Technologies — in Scottsdale, Arizona licenses the technology for research and evaluation.

Cerebral reset

Cereset Research with Standard Operating Procedures, or CR-SOP, is an updated form of Hirrem that the authors say is a simpler and more scalable process that allows for less operator-intensive monitoring and control. The Cereset technology — Cereset is  an acronym for cerebral reset — also uses smarter software protocols and faster computer systems to manage the treatments, enabling a more standard package with shorter therapy sessions. As with Hirrem, the system feeds back audio tones, delivered through earbuds to the patient.

In the clinical trial, Tegeler and colleagues pilot-tested CR-SOP as therapy for insomnia. “CR-SOP allows the brain to reset from stress patterns that contribute to insomnia,” says Tegeler in a Wake Forest statement. “During the intervention, the brain continuously updates with respect to its own activity patterns, resulting in auto-calibration or self-optimization.”

The trial enrolled 22 adults at the Wake Forest medical school diagnosed with clinical insomnia, defined as scoring 8 points or higher on a 28-point Insomnia Severity Index. Participants were randomly assigned to receive 10 sessions of CR-SOP or 10 sessions of random audio tones as a placebo, then assessed for sleep quality with Insomnia Severity Index over an average of 15 days. The study team also measured heart rate variability and baroflex sensitivity — an indicator of nervous system interaction with cardiac functions — during this period, as well as four to six weeks after the sessions.

Results show 20 of the 22 participants completed the trial, with no treatment-related adverse effects reported. CR-SOP recipients report lower insomnia severity index and higher sleep quality scores than random-tone recipients, soon after the sessions, and after the 4-6 week follow-ups, with differences large enough for statistical reliability. Likewise, the CR-SOP group reports improvements in heart rate variability and baroflex sensitivity than the random-tone recipients.

“This pilot study demonstrates these benefits with CR-SOP from sessions received over a short period,” notes Tegeler. “This is also an important step in showing the intervention’s potential scalability for treating more people.”

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New Venture Funds to Back Life Science, Tech Start-Ups

Investor screen

(Stephen Dawson, Unsplash)

26 Jan. 2023. Three new venture funds are seeking to invest up to $6.3 billion in start-up companies with advances in life sciences, health care, energy, and information technologies. New Enterprise Associates is offering two new funds supporting entrepreneurs developing life science/health care and technology solutions, while Pegasus Tech Ventures is partnering with Denka Company Ltd., a chemical manufacturer in Tokyo, to establish a corporate venture fund for investing in a range of new technologies.

New Enterprise Associates in Menlo Park, California and New York unveiled two investment funds totaling $6.2 billion for financing start-ups creating advances in life sciences, health care, and information technology. NEA says its life science and health care investments aim to support drug discovery and therapies in all major disease areas, as well as digital health and devices addressing diagnostics and drug delivery. The company says it backs information technology start-ups developing processes disrupting current software, services, systems, semiconductor, consumer, and Internet markets.

NEA says both of its new funds plan to invest in health care, life science, and IT start-ups, with one fund financing early-stage companies and the other fund supporting growth-stage businesses. The company says it now manages some $25 billion in assets. NEA both leads and takes part in venture rounds. Science & Enterprise has reported on several NEA investments, including leadership of a $53 million first venture round for synthetic biology company Senti Biosciences in Feb. 2018, as well as seed-stage rounds in Feb. 2022 totaling nearly $43 million for two companies developing artificial intelligence technologies.

“Health care innovation has never been more important than at this moment in time,” says NEA general partner Mohamad Makhzoumi in a company statement. Makhzoumi adds that NEA plans to build on its “legacy of creating and investing in the next generation of tech-enabled health care disruptors and transformational life sciences companies.”

Venture Capital-as-a-Service

Pegasus Tech Ventures in San Jose, California provides direct venture funding, but also works with corporations providing what it calls Venture Capital-as-a-Service to help guide those companies’ venture investments. Denka Company is collaborating with Pegasus on its $100 million corporate venture fund to support investments in a broad range of new technologies. Pegasus says it manages more than 30 such funds for corporate partners.

Denka Company, founded in 1915, is a developer and manufacturer of chemicals and materials used in electronics, batteries, construction, agriculture, plastics, and pharmaceuticals. The company’s long-range plan, called Mission 2030, aims to position Denka to better reflect emerging global trends, including more sustainability, to build greater business value in the future.

To help achieve that goal, says Denka, it’s starting a corporate venture fund with Pegasus to support new advances in information technologies, energy, health care, and what it calls “sustainable living”. Denka says it aims to invest in start-ups worldwide, including the U.S., Europe, Israel, and Asia.

“We value the experience that Pegasus brings working across many cultures,” says Toshio Imai, President and CEO of Denka Company in a Pegasus Tech Ventures statement released through Cision, “including Japan, the U.S., and Europe, and the expertise that Pegasus brings facilitating corporate innovation by investing in strategic technologies that can be valuable to Denka.”

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Grocery Chain Offering Sites for Cancer Biomarker Trial

Kroger store in Kentucky

Kroger store in Shepherdsville, Kentucky (Ambrosia LaFluer, Flickr. https://flic.kr/p/2kEVHa3)

25 Jan. 2023. The Kroger grocery store chain in the U.S. is establishing a clinical trial network through its urgent care centers, starting with a study of microbiome cancer biomarkers. The trial is an observational study of microbial communities in the gut to identify precise biomarkers of immune health affecting four types of solid-tumor cancers.

The Kroger Company, based in Cincinnati, Ohio,  is a chain of some 2,800 stores in 35 states, with sales of more than $32.5 billion, according to the company. The chain provides urgent care services at 226 of its stores called Little Clinics offering walk-in, appointment, and telehealth services for diagnostics, screenings, physicals, minor injuries, and vaccinations. The clinics, says the company, are staffed with nurse practitioners and physician assistants, and open seven days a week, including evenings. Kroger also operates more than 2,200 in-store pharmacies.

Kroger says its Little Clinics and pharmacies are now available to serve as clinical trial sites. The chain’s first trial seeks to identify biomarkers, or molecular identifiers, of four solid-tumor cancers: non-small cell lung cancer, triple negative breast cancer, colorectal cancer, and pancreatic cancer. The clinical trial, conducted by Persephone Biosciences Inc. in San Diego, is an observational study that aims to enroll up to 4,000 patients with these four types of cancer in stage 3, where the cancer grows and spreads to lymph nodes or other tissues, or stage 4, where the cancer spreads to other organs, known as metastatic cancer.

Enrolling those at risk for colorectal cancer

The trial’s study team is collecting at least two blood and stool samples from the cancer patients, then tracked for up to eight years. Persephone Bio, a developer of engineered biologics addressing microbiome disorders, is collecting the samples in a biobank for detailed analysis, tied to the patients’ electronic health records. The company’s analysis aims to connect the condition of patients’ microbiome, communities of bacteria in the gut, with genomic and metabolic conditions. Science & Enterprise reported in Sept 2022 on the start of the trial.

Kroger’s Little Clinics and pharmacies are participating in the colorectal cancer part of Persephone Bio’s study. The chain is seeking participants age 45 or over normally candidates for a colonoscopy, those age 18 or over with first-degree relatives with a colon cancer history, and individuals with a personal history of colorectal cancer or found with three or more polyps in a colonoscopy. Kroger says its clinics and pharmacies in the Toledo, Ohio region are the first sites taking part in the trial, with a goal of enrolling 55 participants.

One of Persephone Bio’s objectives in the trial is to enroll a more racially diverse patient population than usually recruited in clinical studies. Kroger says about half (51%) of its stores are located in “socially vulnerable areas”. The company says with these locations, it can enroll more diverse clinical trial samples, and use personalized digital tools, such as virtual visits, to increase retention rates.

“This is the first of many clinical trial opportunities,” says James Kirby, chief commercial officer of Kroger Health in a company statement, “that will utilize us as an alternative to the traditional clinical trial and research organization model.” Kroger stores are not alone in offering their widespread retail locations as clinical trial sites. Walmart, Walgreens, and CVS also offer their stores and clinics for recruiting more diverse clinical trial participants.

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Trial Underway Testing Bioelectronic Incontinence Device

neurons

(NIH.gov)

24 Jan. 2023. The first participants are enrolled in a clinical trial of an implanted bio-feedback device to help women control urinary incontinence, sudden or stress-related urges to urinate. The study is conducted by the start-up company Amber Therapeutics Ltd. in London, spun-off from a biomedical engineering lab at University of Oxford.

Urinary incontinence is a condition experienced often by older people, mainly women, where urine leaks accidently from the bladder. The condition results from weakened or overactive muscles around the bladder as a result of age, but can also occur from vaginal or urinary tract infections, or as an effect of Parkinson’s disease, multiple sclerosis, arthritis, or diabetes. In men, the condition can result from an enlarged prostate, or disease or injury to the prostate. Incontinence can occur as a sudden urge to urinate or from stress on the bladder from strenuous exercise, coughing, or sneezing.

Amber Therapeutics, founded in 2021, develops bioelectronic medical devices to treat disorders of the peripheral nervous system, the network of neurons carrying signals outside of the brain and spinal cord or central nervous system. The peripheral nervous system contains the autonomic nervous system that processes unconscious functions in the body, such as heart and respiratory organs, as well as sensory and muscle-movement functions.

Closed-loop device

Amber says it develops electronic devices that interact with the peripheral nervous system by sensing and interpreting nerve signals, then responding with corrective electronic signals when needed, controlled by adaptive algorithms. The company’s technology is based on research in the lab of Oxford engineering professor Tim Denison, a co-founder of Amber Therapeutics, that studies nervous system processes for the design of bioelectronic devices monitoring brain signals and regulating physiological functions.

The company’s first product, called Amber-UI, is a device to help control urinary incontinence in women, implanted with a minimally-invasive procedure. The closed-loop device, says Amber, addresses overactive bladder from both sudden urges to urinate and stress incontinence. The system has two sensing electrodes monitoring the pudendal nerve connected to an implanted pulse generator. The pudendal nerve is a major nerve pathway connecting organs and sphincter muscles in the pelvic region to the brain, including those controlling urination. The device adapts another bioelectronic device, the Picostim DyNeuMo for deep brain stimulation, developed by Bioinduction Ltd., a company also based in part on research in Denison’s lab.

The clinical trial is enrolling 15 women age 18 to 75 with urinary incontinence at University Hospital Antwerp in Belgium. The study is assessing the safety of the Amber-UI device, with the study team looking mainly for adverse effects of the implant up to a year from implantation. The team is also periodically tracking urination behavior with questionnaires and a diary, quality of life and related lifestyle factors, and technical performance of the Amber-UI device for up to six months. The company says the first three participants received their implanted devices, with the remaining 12 individuals expected to be enrolled by the end of June.

“With Amber-UI,” says Stefan De Wachter, Professor of Urology at Antwerp University, and lead investigator of the clinical trial in a company statement released through Cision, “we stimulate the pudendal nerve, the natural pathway of continence control, and can reinforce the existing physiologic reflexes when it is needed. With our Amber-UI adaptive therapy, we finally have the potential to control both forms of incontinence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence.”

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Damaged Human Lungs Restored for Transplantation

Yorkshire swine in a barn

Yorkshire swine (Edward Headington, Flickr. https://flic.kr/p/fvfie6)

23 Jan 2023. A research team demonstrated the feasibility of connecting anesthetized pigs to human lungs deemed unfit for transplants, for recovering the lungs to transplant quality. A team from Columbia, Vanderbilt, and other universities and the company Xylyx Bio Inc. in Brooklyn, New York demonstrated the technique, announced today by the company, and published earlier in The Journal of Heart and Lung Transplantation (paid subscription required).

The researchers are seeking to improve the supply of organs available for transplant, a particular problem for lungs, where according to data cited by Xylyx Bio, 80 percent of donated lungs are not considered of suitable quality for transplant. Moreover, says the company, damage to lungs in many cases is from reversible conditions, making repair of many damaged lungs technically possible.  Lung transplants are often the only way to treat patients with end-stage lung disease, the most severe form of lung diseases, such as chronic obstructive pulmonary disease or COPD, emphysema, and chronic bronchitis.

Biomedical engineering labs at Columbia University in New York and Vanderbilt University in Nashville designed the process for damaged lung recovery. As reported in Science & Enterprise in May 2019, a team from the labs of Gordana Vunjak-Novakovic at Columbia and Matthew Bacchetta at Vanderbilt built on current techniques for ex vivo, or outside-the-body, lung perfusion for improving the state of lower-quality lungs for transplant, to enable restoring damaged lungs that did not meet transplant standards. At the time, the team demonstrated on pigs techniques for restoring damage from gastric aspiration, where acids in the stomach burn lung and airway tissue.

Synthetic cobra venom proteins

The researchers in this case are seeking to establish a standard, feasible, and reproducible process for recovering damaged lungs. In their study, Vunjak-Novakovic, Bachetta, and colleagues applied their process called xenogeneic cross-circulation, where whole blood from anesthetized animals, in this case Yorkshire and Landrace breed swine, is sent from the pigs into nine human lungs rated as too damaged for transplant, then back to the pigs. The animals are treated with immunosuppressive drugs, as well as synthetic cobra venom proteins that deplete the complement system, part of the immune system protecting against invading pathogens. The team tested lung quality every six hours with bronchoscope observation and microscope inspection.

After 24 hours of xenogeneic cross-circulation, say the authors, capacity of air sacs in the nine damaged lungs increased by 158 percent and dynamic pulmonary compliance, a measure of lung elasticity, increased by 127 percent. Airway and blood pressures in the lungs, and lung weight remained stable. In addition, the structure of the lungs and their ability to exchange oxygen and carbon dioxide between the lungs and blood stream remained intact.

Vunjak-Novakovic founded Xylyx Bio in 2016 with John O’Neill, now the company’s chief scientist. Vunjak-Novakovic and Bacchetta serve on Xylyx Bio board. The company offers a service for repair and recovery of damaged donor organs, including lungs, for transplant, building on the xenogeneic cross-circulation technology.

“Xenogeneic cross-circulation is proving to be a robust method for ex vivo support, evaluation, and improvement of donor lungs,” says Bachetta in a Xylyx Bio statement released through Cision. “Our technique,” adds O’Neill, “provides donor organs a healthy blood supply with sustained multi-system physiological regulation, a powerful advantage that is unique in the field.”

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Infographic – Digital Health Venture Funds Crater in Q4 2022

 

Chart: Digital health venture funding by quarter

Click on image for full-size view (CB Insights)

21 Jan. 2023. Venture funds for new companies developing digital solutions for health care continued dropping throughout 2022, reaching their lowest levels in years in the fourth quarter. Technology industry research company CB Insights reported the findings last week as part of its 2022 State of Venture report (registration required).

CB Insights defines digital health companies as those providing IT services to health care enterprises, as well as digital therapeutics, telehealth, and technology applied to mental health and clinical trials. For all of 2022, digital health start-ups worldwide raised $25.9 billion in 2,122 deals, the lowest investment dollar total since 2019 and the fewest number of annual deals since 2018. In 2021 venture investors placed $59.7 billion in the sector, in 3,160 transactions. CB Insights says for all of the technologies it follows, digital health was the only sector to record fewer investment dollars and deals in 2022 than 2020.

Quarterly investment dollars and deals in digital health start-ups during 2022 began falling in the first half of the year, with the declines continuing in the last two quarters. In the fourth quarter, according to CB Insights, new digital health companies raised $3.4 billion in 366 deals, the lowest quarterly totals since 2018. The vast majority of Q4 venture investment dollars and deals in digital health were in U.S. companies — $2.5 billion in 201 deals.

Some 60 percent of digital health venture deals in 2022 went to early-stage companies, about the same percentage since 2020. And for perhaps the only bright spot in the report, the median-size deal has grown steadily since 2018, rising to $4.5 million in 2022 from $4.4 million the previous year. The average deal size, however, declined in 2022 to $15.2 million from $24.4 million in 2021.

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Types of Tax Forms for Businesses

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21 Jan. 2023. Small business owners, entrepreneurs, freelancers, and corporate finance executives have to deal with business taxes regularly.

Tax season comes every year, and even though it’s always the same, it’s still hard to deal with. If you own a small business, filing business taxes might be scary.

This post lists the major tax forms a business owner should consider while preparing tax information. Remember that keeping track of each item on the list all year long is better than hurriedly putting together forms at tax time.

Tax Forms for Businesses Relating to Employees

When hiring people, business owners need to know which tax and IRS forms they need to fill out. Some of these files include:

IRS Form 1099

What is form 1099? Form 1099 is a tax form that taxpayers use to tell the Internal Revenue Service (IRS) about the miscellaneous income they receive throughout the year. It comes in different forms, such as 1099-MISC, 1099-NEC, and 1099-INT. Freelancers who receive final versions from individual clients are most likely to use this form.

Withholding Certificate for Employees: Form W-4

Employees fill out Form W-4 to show the amount that IRS should withhold from their payrolls. Employees use this form to report personal information, employment status, dependents, and tax modifications.

Wage and Tax Statement: W-2 Form

Form W-2 is given to employees by their employers. This form contains essential information on the salary of full-time and part-time employees, annual wages, and tax withholdings. Businesses issue W-2 forms to their employees by January 31.

Tax Forms for Businesses to File

Business owners also need to send or issue specific paperwork. Some of these papers are given to employees, while others must be submitted directly to the IRS.

Form 1040

What is Form 1040? Form 1040 is the Individual Income Tax Return. This form helps to:

  • Determine your filing status
  • Declare your earnings.
  • Make a standard deduction claim.
  • Report dependents.

Business Profit and Loss: Schedule C

Schedule C is for sole proprietorships and is called “Profit or Loss from Business.” This form needs to be filled out along with a standard 1040 form. The information on Schedule C helps the IRS determine how much you owe in taxes. It also allows you to find write-offs that lower the amount you have to pay.

Return of Partnership Income: Form 1065

If your business is a partnership, you will have to pay taxes for both the partnership as a whole and the people who make up the partnership. As a partnership, you must fill out Form 1065, an annual information return, to report your business’s gains, deductions, income, credits, and losses.

Corporation Income Tax Return: Form 1120

This form reports income or losses for the corporation. A corporation must submit Form 1120 annually. The stages on the form should establish and declare a company’s income tax liability.

Conclusion

Although most business owners find preparing tax documents and reporting company income complex, in-depth knowledge of the required documents can be helpful.

This guide is a good starting point for business owners who want to stay organized all year, but it doesn’t cover everything. If you have questions about your business’s finances that are unusual or specific, talk to a certified tax expert.

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Psychedelic Drug Shown to Relieve PTSD Brain Signals

Brain circuits

(NIH.gov)

20 Jan. 2023. A small clinical trial shows psychotherapy with the psychedelic drug MDMA generates brain signals that help relieve symptoms in people with post-traumatic stress disorder. Findings from the trial conducted by the MAPS Public Benefit Corporation appear in the 12 Jan. issue of the journal Frontiers in Psychiatry.

Post-traumatic stress disorder or PTSD is a chronic debilitating psychiatric disease marked by recurring flashbacks, dreams, and fearful episodes, often resulting from first-hand experiences with traumatic or dangerous experiences, such as military combat. When people with PTSD experience these symptoms, they often engage in behaviors to avoid triggering their fears and emotions, as well as loss of sleep, broken relationships with friends and family, and negative thoughts about themselves. PTSD is treated mainly with psychotherapy, although new drugs for the condition are also being developed.

Researchers from MAPS Public Benefit Corporation, a subsidiary of Multidisciplinary Association for Psychedelic Studies, a not-for-profit organization in San Jose, California, study the therapeutic effects of so-called mind-altering drugs for treating psychiatric disorders. One of those compounds is 3,4-methylenedioxy-methamphetamine or MDMA, more commonly known as ecstacy. MDMA is a synthetic chemical similar to stimulants, known to increase production in the brain of dopamine that increases energy and activity, and serotonin affecting mood, appetite, sleep, and hormones affecting trust and sexual arousal. MDMA also boosts norepinephrine in the brain, a chemical increasing heart rate and blood pressure, making MDMA potentially dangerous for people with heart conditions.

A team from MAPS Public Benefit Corporation, Medical University of South Carolina, and other institutions sought to learn more about the workings of MDMA in the brains of people with PTSD. The researchers cite several clinical studies showing benefits from MDMA for people with PTSD as part of their therapy. But in this study the team aims to discover more precise ways MDMA works in the brains of people with PTSD to gain those benefits. The researchers hypothesized MDMA would modify recruitment of signals in parts of the brain generating hyperactive fear responses, particularly the amygdala that regulates emotions such as fear and aggression, the hippocampus controlling memory, learning, emotion, and motivation, and insula affecting a wide range of sensory, affective, and cognitive functions.

Audio scripts with neutral and fear-arousing stories

To track these brain activities, the researchers used a technique called functional MRI, a type of magnetic resonance imaging that graphically displays blood oxygen levels in the brain in real time as an indicator of brain activity. For this clinical trial, the team recruited 10 participants in a larger clinical study testing MDMA dosage levels among participants with PTSD in psychotherapy sessions. Of the original 10 individuals, nine completed the trial, of which eight were military veterans and one civilian first-responder.

Participants were assessed for PTSD symptoms at the beginning of the study, then followed their prescribed treatments that included psychotherapy both with and without MDMA. During the sessions they heard six-minute audio scripts with neutral and fear-arousing stories during which they submitted to functional MRI brain scans, including a follow-up session after two months.

Results of the functional MRI scans show increased brain activity connecting the amygdala, hippocampus, and insula indicating better ability to process fears and emotions during the fear-arousing scripts heard by participants in MDMA-assisted psychotherapy. However, the scans show this brain activity occurring more on the left side of participants’ brains, not the entire brain. The researchers also found fewer differences between fear-arousing and neutral scripts among MDMA-assisted patients in signals to the cuneus in the brain that processes visual information. And, changes in brain signal connections among the amygdala, hippocampus, and insula in MDMA-assisted patients correlated with fewer reports of PTSD symptoms.

“These data add to our understanding of the biological rationale for using MDMA combined with therapy in the treatment of PTSD,” says MAPS Public Benefit Corporation CEO Amy Emerson in a company statement. “The results suggest that treatment with MDMA-assisted therapy may help reset the dysregulation in the brain caused by PTSD and that the effects are durable even two months after treatment.”

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Real-World Data Shown to Match Eye Disease Trial Results

Fundus photograph

Fundus photograph of a healthy right eye (OptometrusPrime, Wikimedia Commons)

19 Jan. 2023. Research findings show data in patients’ electronic health records can be collected and analyzed to replicate results from late-stage clinical trials of an eye disease biologic drug. Results of the study conducted by a team from Stanford University and life science and health analytics company Verana Health in San Francisco, appear in the 1 Jan. issue of the journal Ophthalmic Surgery, Lasers and Imaging or OSLI Retina.

Verana Health collects and analyzes real-world health data from databases the company says represent some 90 million patients generated by de-identified records from 20,000 health care providers and medical associations in ophthalmology, neurology, and urology. The company says its analytical engine uses artificial intelligence to transform structured and unstructured data in electronic records to produce curated disease-specific data modules. Verana also provides its analytical software as a service to generate real-world medical evidence, assist in clinical trials, and manage data in medical registries.

In the study, a team from Stanford and Verana Health tested a data set from de-identified health records of patients with neovascular or so-called wet age-related macular degeneration or AMD, a common eye disease among older individuals where the retina deteriorates, leading to loss of visual acuity. The retina is a layer of light-sensitive tissue in the back of the eye, where images are focused and converted to electrical impulses sent through the optic nerve to the brain. With wet AMD, abnormal growth of blood vessels occur under the retina that bleed or leak, causing distortion in the retina’s structure.

In the previous decade, a number of new treatments for wet AMD emerged that control the abnormal development of blood vessels in the eye. These new drugs block a protein called vascular endothelial growth factor or VEGF that encourages blood vessel growth. Among the new drugs authorized by FDA to control VEGF for eye diseases are aflibercept, a biologic drug marketed as Eylea by Regeneron and ranibizumab, marketed as Lucentis by Genentech. Both drugs are injected periodically into the eyes.

Health data records from eye patient registry

Regeneron tested aflibercept in two late-stage clinical trials, first among wet AMD patients in the U.S. and Canada from 2007 to 2011, and in Europe, Asia, South America, and Australia from 2008 to 2011. In both trials, participants were randomly assigned to receive aflibercept , an experimental drug at the time, or a then-current treatment ranibizumab for comparison.

The Stanford/Verana Health team drew on health data of patients in the Intelligent Research in Sight or IRIS Registry maintained by American Academy of Ophthalmology. The researchers sought records of patients receiving injections of aflibercept or ranibizumab from Jan. 2013 through Dec. 2018. From that population, the team sought to match patients in the IRIS registry to eligibility and treatment conditions in the clinical trials.

Results show of the 90,900 patients with IRIS registry records meeting the clinical trial eligibility criteria, 4,457 or about five percent also matched the treatment group requirements. Of those patients meeting both eligibility and treatment group criteria, 90 percent maintained vision after one year. And, differences among the treatment groups — those taking aflibercept monthly or bi-monthly, or ranibizumab monthly — were not large enough for statistical reliability.

Even though the percentage of registry patients meeting both eligibility and treatment criteria was only five percent of the original cohort, the authors conclude this test of real-world data generates results replicating the endpoints in the original clinical trials. Plus, Verana Health believes these real-world data can support submissions to regulatory agencies, reducing time and cost of bringing new drugs and medical devices to market.

“This was a great pilot experiment to show that this type of analysis was possible,” says Stanford University ophthalmology professor and the paper’s senior author Theodore Leng in a Verana Health statement. “The next step is to determine whether we can replicate results in other trials and develop confidence in real-world data as a foundation from which we can scale.”

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QuickDNA Tests Meet International Lab Industry Standards

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DNA illustration

(Nogas1974, Wikimedia Commons)

19 Jan. 2023. For laboratory tests with enormous consequences to their subjects, it’s vital that the labs conducting the tests meet exacting standards for quality and reliability. For that purpose, the International Organization for Standardization or ISO in 2005 devised its standard 17025 for testing and calibration laboratories, published with the International Electrotechnical Commission or IEC.

ISO/IEC 17025, revised and updated since 2005, is designed to assure users of reliability of lab test results, along with sampling and calibration services. The standards apply to labs in government agencies, universities, and not-for-profit organizations, as well as private companies. The Covid-19 pandemic revealed the high public health need for reliability in lab tests, to detect and control the SARS-CoV-2 virus.

But lab test results can have enormous personal as well as public health consequences. An example of this type of test is one for DNA parentage, to determine family connections. Results of these tests can reveal familial links from DNA, often to answer sensitive paternity questions, where results can determine financial obligations or even criminal penalties.

DNA, short for deoxyribonucleic acid, is made of two linked strands of amino acids, with the sequence of those amino acids making up an individual’s genetic code. Much of a person’s genetic code is passed down from parents, where high degrees of similarity in DNA sequences indicate family connections. Most tests use minimal or non-invasive biological speciments such as blood sample or saliva swab, although in some cases hair, gum, or used toothbrushes can be used.

The company QuickDNA offers its DNA Parentage Test to answer questions of family connections, and says its labs are certified compliant with ISO/IEC 17025 standards. The company says it returns results in 72 hours and keeps the findings confidential. QuickDNA also offers DNA tests for prenatal parentage, as well as ancestry and animal breed determination.

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