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FDA Authorizes Non-Prescription Covid-19 Test

Cue Covid-19 test

Cue Covid-19 test. Click on image for full-size view (Cue Health Inc.)

6 Mar. 2021. Food and Drug Administration granted an emergency authorization for a molecular test for SARS-CoV-2 viruses done at home without a prescription. The FDA’s action authorizing the Cue Covid-19 Test by Cue Health Inc. in San Diego is the first clearance for an over-the-counter molecular test of viruses responsible for Covid-19 infections.

The Cue Covid-19 Test uses mid-nose nasal swabs to collect a sample for analysis, rather than the deep nasopharyngeal swab used in professional RT-PCR tests that require a clinician. Adults can take swabs from their own nose or from children age two or more. The swab is inserted in a single-use test cartridge that amplifies RNA in the sample for analysis, with the cartridge then inserted into a cartridge reader. The reader returns results in about 20 minutes, displayed on a companion mobile app, available only for Apple iPhone 8 Plus or newer and iOS version 13 or higher. The company says an Android version of the app is in development.

Cue Health tested its Covid-19 test in August 2020 at a Mayo Clinic drive-through testing facility in Mankato, Minnesota, with results published in the journal Diagnostic Microbiology and Infectious Disease. Some 292 individuals were randomly assigned for conventional RT-PCR testing or the Cue Health test. The results show positive tests for SARS-CoV-2 viruses with the Cue Health test matched RT-PCR tests 92 percent of the time, with negative tests from the Cue Health device matching RT-PCR results 98 percent of the time.

The Cue Health test was first authorized by FDA for clinical use in June 2020, and the company says it’s now in use in doctors offices, hospitals, schools, businesses, dental clinics, and long-term care facilities. FDA says Cue Health plans to produce 100,000 tests by the summer of 2021. “For the first time,” says  Ayub Khattak, co-founder and CEO of Cue Health in a company statement, “consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of Covid-19 testing.”

As reported by Science & Enterprise on 1 Mar., FDA authorized another home test for antigens indicating the presence of SARS-CoV-2 viruses, but requires a prescription. Quidel Corp., the company developing the test, says it plans to submit findings to FDA for clearance also as a home over-the-counter test.

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Two Therapies Dropped from NIH Covid-19 Trial

SARS-CoV-2 and cell

Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH)

5 Mar. 2021. A clinical trial testing multiple treatments for people hospitalized with Covid-19 infections is dropping two therapies for not meeting efficacy standards. The Activ-3 trial sponsored by National Institute of Allergy and Infectious Diseases or NIAID, part of National Institutes of Health, removed from the trial synthetic antibody treatments made by Brii Biosciences in Durham, North Carolina and Beijing, and Vir Biotechnology in San Francisco.

The trial is part of NIH’s Accelerating Covid-19 Therapeutic Interventions and Vaccines, or Activ, program to streamline and coordinate actions to combat the Covid-19 pandemic among agencies in the U.S. government, private pharmaceutical and biotech companies, international agencies, and not-for-profit groups. Among Activ’s goals is to accelerate evaluation of vaccine and therapy candidates to speed regulatory approval, including clinical trials of experimental drugs.

Activ-3 is enrolling 10,000 participants at 78 sites worldwide hospitalized with Covid-19 disease, to test safety and efficacy of several therapies. The trial uses an adaptive design that allows for changing the course of the study while underway, without compromising gold-standard quality of the efficacy or safety data. Adaptive trials are usually governed by a single governing board and master protocol spelling out ground rules for the study, including standards and processes for assessing results, adding or closing sample groups, and adding new drugs or devices for testing.

As reported by Science & Enterprise in December 2020, Activ-3 under its master protocol, added a combination of two synthetic antibodies made by Brii Bio, code-named BRII-196 and BRII-198, designed to neutralize SARS-CoV-2 viruses, while reducing the risk of antibody-dependent enhancement, an unintended consequence that makes it easier for the original viruses to infect cells.

The study also added Vir Biotech’s synthetic antibody code-named VIR-7831, licensed to drug maker GlaxoSmithKline. Vir Biotech creates synthetic antibodies that work like natural, but often rare, antibodies produced by people who recover from infections, in this case from SARS-CoV-2 viruses responsible for Covid-19.

Not meeting pre-defined efficacy criteria

Brii Bio says in a statement that Activ-3’s independent data and safety monitoring board reviewed the first phase of data from 343 participants randomized to receive either the BRII-196/BRII-198 combination or a placebo. The board found findings from these participants on five ordinal rating scales indicate recipients of the synthetic antibodies did not meet the pre-specified effiacy criteria for continuing the trial.

A comparable review of 344 participants by the Activ-3 board found VIR-7831 also did not meet pre-specified effiacy criteria for continuing the trial. NIAID says in a statement that initial findings show VIR-7831 with clinical benefits, but placebo recipients in the trial were in a more advanced disease state than VIR-7831 recipients, and after adjustments in the data, those initial gains were erased.

The initial data did not indicate any safety issues with either therapy. The Activ-3 trial continues testing an experimental long-acting antibody combination code-named AZD7442, developed by drug maker AstraZeneca in Cambridge, U.K. The study’s data and safety monitoring board plans to review initial data for that therapy candidate once findings from 300 participants are collected.

Vir Biotech says two mid- and late-stage clinical trials continue to test VIR-7831 among non-hospitalized patients with mild to moderate forms of Covid-19. And the Activ-2 trial, sponsored by NIAID, is testing the BRII-196/BRII-198 combination therapy, also among non-hospitalized Covid-19 patients.

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Crispr Enables Inhaled Flu, Covid-19 Treatment

Nebulizer mask

Nebulizer mask (Marco Verch, Flickr, https://www.flickr.com/photos/30478819@N08/49918582532)

5 Mar. 2021. A biomedical engineering lab designed and tested in lab animals gene-edited therapies for influenza and Covid-19, inhaled by patients with a home device. The treatment and tests using the gene-editing technique Crispr are developed by researchers from Emory University and Georgia Tech in Atlanta, and described last month in the journal Nature Biotechnology.

A team from the biomedical engineering lab of Philip Santangelo, affiliated with both institutions, is seeking faster development of treatments for infectious disease outbreaks and pandemics, of which Covid-19 is only the latest. Santangelo’s lab studies the biology of RNA-driven viruses, which make up nearly all of the viruses known to infect humans. In this study, the Emory-Georgia Tech team targets regions of viruses that remain constant from one variation to another, with a form of synthetic messenger RNA or mRNA like that used in new vaccines to prevent Covid-19 disease.

To attack viruses with mRNA, the researchers employ Crispr, short for clustered regularly interspaced short palindromic repeats. Crispr is a genome-editing process based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA. Most Crispr applications edit DNA with an editing enzyme called Cas9. In this project, the team used an RNA-editing enzyme called Cas13a, which edits with multiple cuts in RNA strands. As reported by Science & Enterprise in December 2020, Cas13a is being studied for home-based Covid-19 diagnostics.

To treat respiratory diseases, the researchers attack with Crispr-Cas13a enzymes the RNA that codes for the constant parts of viruses. In this study, the team turned to colleagues at Centers for Disease Control and Prevention, also in Atlanta, for genetic sequences representing known strains of influenza and SARS-CoV-2 viruses responsible for Covid-19. Those sequences revealed the best targets in the genomes for their proposed treatments: the PB2 region in influenza that determines the virus’s virulence and the replicase gene that governs protein production in SARS-CoV-2 viruses, as well as the nucleocapsid gene that codes for the virus’s outer membrane protein.

Formulated as a breathable mist

The team designed their treatments with a similar structure, where only the Crispr RNA to guide the Cas13a enzymes is changed. “It’s really quite plug-and-play,” says Santangelo in university statement adding, “We let the biology dictate what our targets would be.”

In addition, the researchers formulate their synthetic mRNA treatments with a biocompatible polymer, poly-beta amino esters or PBAE that makes it possible to deliver the treatments as a breathable mist using a device called a nebulizer. This device has a small compressor that turns liquids into vapors and can be used at home with a mask or mouthpiece. The team built a nebulizer-like device to test its mRNA treatments with mice and hamsters.

Results of the tests show the treatment for influenza degraded the RNA in lung tissues of infected mice. And with hamsters infected with SARS-CoV-2, the treatment reduced both viral replication and symptoms. The team notes that mRNA treatments have a limited durability in the body, which enhances their safety. “The mRNA is transient,” says Santangelo. “It doesn’t get into the nucleus, doesn’t affect your DNA.”

The research was funded by a grant from a Defense Advanced Research Projects Agency, or Darpa program to create safe, effective, and easily deployable medical countermeasures for pandemics. Those requirements led to a nebulizer formulation for the proposed therapies.

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Small Biz Grant Funds Hibernating Animal Drug Discovery

Brown bear

(Becca, Unsplash, https://unsplash.com/photos/_r6w0R6SueQ)

4 Mar. 2021. A company identifying drug targets from genetic processes in hibernating animals is receiving an NIH grant to advance its technology for heart disease. Fauna Bio, a three year-old enterprise in Berkeley, California, is receiving a one-year $373,434 award from National Human Genome Research Institute, or NHGRI, part of National Institutes of Health.

Fauna Bio identifies pharmaceutical targets in genes of hibernating mammals that allow their biological processes to be switched off and on. These genes, says the company, provide protection to hibernating animals from similar processes that would cause serious disease or injury to humans. Since humans share the vast majority of their genetics with other mammals, often 90 percent or more, a systematic investigation of genetic processes that protect hibernating animals can offer new targets for drugs to treat several types of diseases.

For example, prior to hibernation, animals become obese and insulin resistant, then cease all food intake during hibernation. Also, hibernating animals remain sedentary for several months, yet do not suffer bone loss or muscle atrophy. And, neurons or nerve cells in the brains of hibernating animals form tau protein plaques as in Alzheimer’s disease in humans and their synapses lose connectivity, yet these animals do not suffer comparable brain damage in humans.

Fauna Bio investigates genetic processes that protect hibernating animals and looks for comparable or translatable genes in the human genome that could be switched on or off to protect against their injurious effects. The company uses computational tools, including deep machine learning, to identify drug chemistries most likely to achieve the desired outcomes.

Identify protections against heart attack or stroke

The NHGRI grant supports further development of Fauna Bio’s technology overall, but focusing on genetic properties of hibernating animals that protect against injury from ischemia and reperfusion events, when blood flow to tissues is interrupted and then restored. In hibernating animals, ischemia and reperfusion can occur 20 times or more during the animal’s hibernation, yet in humans those events result in serious health issues, including heart attack or stroke.

In the NHGRI project, Fauna Bio plans to validate targets from hibernating species that protect against ischemia and reperfusion events. The company says it already identified two compounds that could help reduce damage to people suffering heart attacks.

Ashley Zehnder, co-founder and CEO of Fauna Bio, says in a company statement released through Cision that “given that we share 90 percent of our genes with other mammals, it is important to look outside our own species to find new answers for the betterment of human health.” Zehnder adds, “This grant from the NIH means that they see a direct link between the genes of humans and animals, and its value for developing meaningful therapeutics for a variety of complex diseases currently with no viable treatment options.”

In this project, the company is partnering with the Monarch Initiative, a data and analytic platform that identifies shared traits among animal species and connects those traits to genomic properties. That initiative aims to find better animal models for human disease, and offers algorithms and other computational tools to support its work.

The award is a Small Business Technology Transfer or STTR grant made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. STTR grants support collaborative industry-academic research projects.

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Mental Health Requests Rise During Pandemic

Sad, depressed

(Daniel Reche, Pixabay)

4 Mar. 2021. An analysis of health records shows requests for mental health services increased markedly during the early months of the Covid-19 pandemic. Researchers from Kaiser Permanente in Northern California, a health care plan and provider based in Oakland, present the findings in yesterday’s issue of the Journal of Clinical Psychiatry (registration required).

A team led by Kathryn Erickson-Ridout, a psychiatrist and researcher at Santa Rose Medical Center in California, sought to assess the emotional impact of shelter-in-place orders in the state issued from March until May 2020. During that time Kaiser Permanente and other providers switched to telemedicine to serve much of its patient population, including for psychiatric services.

“Covid-19 has created huge psychosocial disruption,” says Erickson-Ridout in a Kaiser Permanente statement. “It’s impacting people’s ability to work, socialize, and have relationships, and that is having mental health consequences.”

The researchers started with 181,000 electronic health records in the Kaiser Permanente system from 9 Mar. to 31 May 2020, and almost 165,700 records during the same period in 2019, sampling 94,600 records in 2020 and 94,700 in 2019. In those records, the team looked for requests for psychiatric services, as well as demographic characteristics of Kaiser Permanente members requesting these services, as well as from existing or new system members.

The results show requests for mental health services among Kaiser Permanente members rose seven percent during March to May 2020 compared to 2019. The findings show a majority of those 2020 requests were made through telemedicine, either by telephone or video, with the volume of those requests increasing by 264 percent. The largest increases were for addiction services, which rose 42 percent compared to 2019.

The findings show large increases in specific requests for help with substance abuse (51%), adjustment problems (15%), anxiety (12%), bipolar (9%), and psychosis (6%) disorders. Adjustment problems are responses to stressful live events, experienced by sadness or hopelessness.

More younger adults seeking care

“The increases we found in patients seeking care for substance use and anxiety,” adds Erickson-Ridout, “are consistent with other data showing the pandemic and shelter-in-place orders were difficult for many people. These findings reflect what I experienced with my patients who sought out care.”

Kaiser Permanente members requesting more psychiatric services in 2020 tend to be younger adults, age 18 to 39, which increased four percent compared to 2019, while service requests for children and older members decreased by 23 and six percent respectively. Mental health requests from White and male Kaiser Permanente members also declined in 2020 by four and five percent respectively. Service requests from existing psychiatric patients declined slightly (2%), while requests from new patients declined sharply, dropping by 42 percent compared to 2019.

The authors say the results indicate acceptance of telemedicine by many plan members as a feasible option for psychiatric service delivery. A desire to avoid health care facilities contributes to the large jump in telemedicine use, say the authors, as well as help from caregivers to navigate online services.

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Sensor in Works Detecting Covid-19 Airborne Virus

Graphene illustration

(Maxpixel.net)

3 Mar. 2021. A company developing graphene bio-computer chips is applying its technology to sensors that quickly detect SARS-CoV-2 viruses in indoor air. Cardea Bio Inc. in San Diego is developing the sensor for Defense Advanced Research Projects Agency, or Darpa, as a sub-contractor to Georgia Tech Research Institute.

Cardea Bio designs transistor devices that detect live biological signals and convert the signals to electronic data streams. The company says its technology is built as graphene semiconductors that can be tuned to detect biological signals and support semiconductor circuits programmed to interpret the signals and transmit data. Starting with these basic devices, Cardea Bio says it designs applications that combine molecular biology with advanced electronics, software, and artificial intelligence.

Graphene is a material with many desirable qualities for a range of industries. The material is very light, strong, chemically stable, and only one atom in thickness, arrayed in a hexagonal pattern. Graphene can conduct both heat and electricity, with many applications in electronics, energy, and health care. For its bioactive sensors, Cardea Bio says graphene offers a signal resolution high enough to listen into live molecular signals, and can replace optical and static measurements with interactive live-streams from multiple genomic and protein chemical sources.

Sensitivity, specificity, and speed

The company is designing sensors for Darpa’s SenSARS program to detect the SARS-CoV-2 viruses responsible for Covid-19 infections in the environment to alert public health authorities to the virus’s presence. That program aims to develop systems with sufficient sensitivity, specificity, and speed to detect SARS-CoV-2 in an indoor environment, such as class or conference room, within 15 minutes. In addition, the sensor needs to distinguish SARS-CoV-2 from other common indoor contaminants such as dust and other viruses like influenza.

Cardea Bio’s technology is based on research by Kiana Aran, professor of biomedical engineering at Keck Graduate Institute in Claremont, California. Aran’s lab studies bio-microelectromechanical systems for research and clinical use, including graphene-based devices. Among the lab’s work is a transistor built on graphene that applies the gene-editing technique Crispr to detect genomic sequences of target materials.

Aran is also Cardea Bio’s chief scientist. In a company statement released through BusinessWire, Aran says the project offers an opportunity “to develop a real-time pathogen identification technology that can be applied across many sectors. Having already demonstrated scalability and the capability of our platform for direct pathogen detection, we are ready to begin work on the SenSARS program.”

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Micro Robotic Neuro Therapy Company Underway

Brain cell networks

(Gerd Altmann, Pixabay)

3 Mar. 2021. A company designing microscale robotic devices to deliver therapies to the central nervous system began work in public on treatments for brain disorders. Bionaut Labs, founded in 2016 in Los Angeles, is also raising $20 million in its first venture funding round.

Bionaut Labs calls its therapy delivery a form of precision medicine, in that the robotic bionauts can deliver biologics, gene therapies, or small molecule drugs directly to precise targets in the brain. The company’s first applications are treatments for gliomas, a form of tumor affecting glial cells that support neurons or nerve cells in the brain. Bionaut Labs is also designing bionaut deliveries for Huntington’s disease, a rare inherited disorder causing degeneration of nerve cells in the brain.

Bionaut deliveries are made with tiny robotic devices, custom designed and less than a millimeter in size. The devices move by remote control from external magnetic directors, and are shaped and configured with moving parts to interact with different types of tissue where the payloads are delivered. Those interactions can involve incisions in tissue, making bionauts surgical devices as well as drug delivery vehicles. Bionauts are designed to travel through cerebrospinal fluid, brain ventricles, and brain tissue itself thus bypassing the blood-brain barrier that impedes delivery of many drugs to the brain.

Deliver therapies direct to tumors

“The bionaut approach allows us to be free of the constraints of conventional neurosurgery,” says co-founder and CEO of Bionaut Labs Michael Shpigelmacher in a company statement. “They make it possible to get to the precise brain area we want to target, providing the freedom to explore new pathways and remove the device without leaving a footprint.”

Bionaut Labs says its technology has advanced to preclinical studies with lab animals. Those studies include demonstrations of the technology with large animals and delivery of treatments in mice induced with human gliomas. The company says its research with mice shows the technology can guide and deliver therapies directly to tumors without producing adverse reactions elsewhere in the body, a drawback of most other current cancer treatments.

“This approach enhances efficacy and eliminates off-target toxicity, while also allowing the targeting of a wide range of localized diseases with almost any type of therapy,” says Errol DeSouza, who heads Bionaut Labs’ advisory board. “What’s even more exciting is that the anatomical targeting capabilities of the Bionaut platform make new therapeutic technologies such as antisense, siRNA, gene therapy, Crispr-Cas9, and oncolytic viruses viable in challenging clinical settings.”

Technology investor Khosla Ventures in Menlo Park, California is leading Bionaut Labs’ first venture funding round raising $20 million. Taking part in the round are Upfront Ventures, Revolution, BOLD Capital, and Compound. Bionaut Labs says it plans to use the proceeds to advance its work on gliomas and Huntington’s disease.

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NSF Funds AI Covid-19 Drug Combo Simulation

Synthetic biology

(Gerd Altmann, Pixabay)

2 Mar. 2021. National Science Foundation is funding a new system that uses artificial intelligence to find optimal combinations of current drugs to treat Covid-19 disease. The agency awarded the one-year $256,000 project to VeriSIM Life Inc. in San Francisco to adapt the company’s current bio-simulation technology to quickly identify combinations of therapies to treat this increasingly complex disease.

VeriSIM Life is a three year-old company that applies machine learning and other computational tools for predicting a drug candidate’s efficacy before subjecting the drug to live animals and humans for testing. The company says the pharma industry has about an eight percent success rate taking new drugs to market. With advance simulations of a proposed drug’s efficacy, says VeriSIM Life, a company could save considerable time and expense of animal testing and human clinical trials, instead of the current trial-and-error approach.

VeriSIM Life proposes adapting its technology to find optimal combinations of current drugs to treat Covid-19 infections. That technology, called BIOiSIM, uses machine learning, an A.I. technique where large volumes of data train problem-solving statistical models or algorithms. In this case, the models are based on data documenting biochemical interactions with human and animal physiology, with those models simulating toxicity and effectiveness of proposed therapies before they’re used with animals or humans. In a paper published in June 2020, a VeriSIM Life team demonstrated the BIOiSIM technology with efficacy simulations of narcotic pain drugs delivered through skin patches rather than oral drugs or injections.

For Covid-19, the company is building whole-body simulation models to test combinations of existing drugs, either fully approved or authorized by FDA, as well as experimental drugs to minimize infections, viral loads, and replication of the SARS-CoV-2 virus. The models will simulate drug activities with target cells and tissue, expression levels, and interactions with signaling pathways to prevent infection and inflammation. The end result is a technology to match an individual’s condition with drug combinations and dosage levels for best treating Covid-19 infections.

Drug combinations needed for a complex disease

VeriSIM Life says the need is growing for more combinations of therapies to treat an increasingly complex disease. Not only does Covid-19 affect many different organs and functions, but new variants of the SARS-CoV-2 virus are also emerging, which will make treating infections more difficult than before. As a result, the need will likely grow for combinations of drugs to treat Covid-19 infections.

“Leveraging the BIOiSIM to identify and deliver multi-targeted therapies for the treatment of Covid-19,” says VeriSIM Life founder and CEO Jo Varshney in a company statement released through Business Wire, “is one of the many ways we are looking to advance drug development in partnership with pharma and biotech companies.” Varshney adds that “a lesson from this pandemic is that it won’t be the last and we have the opportunity to leverage BIOiSIM to create a scalable pandemic readiness platform that researchers can use for faster, accurate, and efficacious predictions.”

The NSF award is part of NSF’s Small Business Innovation Research or SBIR program in what the agency calls America’s Seed Fund. SBIR grants are set aside for small companies in the U.S. from NSF’s other research funds. SBIR awards are usually divided into two phases, with phase 1 for proving technical and economic feasibility, while phase 2 advances the technology closer to the marketplace. The VeriSIM Life award is a phase 1 grant.

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Getting Started as a Freelance Electrician

– Contributed content –

Telephone box repair

(Pixabay, Pexels)

2 Mar. 2021. Getting started as a freelance electrician could be a great way to become self sufficient, be your own boss, and have more control over your schedule and the jobs you do. However, knowing how to get started is crucial if you’re going to avoid the same pitfalls and mishaps as other people. Here are some pointers on getting started that any startup freelance electrician should find useful:

Work with an experienced electrician first

You might want to get out there on your own right away once qualified, but the best thing you can do is bide your time and work with an experienced electrician first. This will help you to see how the job is done up close without actually taking on much responsibility of your own yet. They can show you the ropes, give you some great pointers, and give you the confidence to avoid many of the pitfalls and mistakes that other people make.

Ask yourself the right questions

Asking yourself the right questions is essential. This way, you can ensure you have a proper plan in place and that you’re not going to fall at the first hurdle. For example:

  • How will you get new customers?
  • How will you cope during quiet periods?
  • Do you have enough money to set up?
  • How will you get by without paid holiday, sick pay, and other benefits?
  • Can you work well on your own?
  • What insurance do you need?
  • Will you be able to manage cash flow?
  • How will you handle your tax responsibilities?

Consider the disadvantages

Of course, you should also consider the disadvantages of becoming a freelance electrician vs getting a job with an established company. First, you’ll need to make sure you can afford the startup costs, or you at least know where you’re going to get your hands on the funds you need. Then, you need to make sure you have some customers, and that you have ways to acquire more as you go along. You may need to deal with inconsistent income, so being able to handle your cash flow is important. Not only that, ensuring you can handle the admin side of things is key. If you can’t work for whatever reason, you won’t be getting paid, either. Make sure you’re ok with all of this before you proceed.

It’s also completely up to you to protect yourself as a freelance electrician. This means finding the right electricians insurance cover and knowing how to keep yourself and others safe as you work.

Marketing yourself

Marketing yourself isn’t easy, but you need to take it seriously if you’re going to become a freelance electrician. You’ll need to research the average pricing for similar services in your area, and price yourself according to that. Knowing your worth is key, but you don’t want to put people off either.

A website with real customer reviews and testimonies can go such a long way to helping you gain clients – as can social media pages. Social proof is a great way to keep people coming to you. Both online and offline advertisements can be a good way to get the word out there that you’re starting up and taking on clients.

Getting started might be the hardest thing you decide to do, but it’ll be so worth it.

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Gene-Edited Transplant Organ Company Raises $125M

Happy pig

(Marion Streiff, Pixabay: https://pixabay.com/photos/pig-alp-rona-furna-sow-happy-pig-214349/)

2 Mar. 2021. A spin-off enterprise from academic labs is raising $125 million for genetically edited pigs to produce organs for human transplantation. eGenesis, in Cambridge, Massachusetts gained the funds in its third venture round since the company’s founding in 2015, based on research by its scientific co-founder geneticist George Church at Harvard University.

The company aims to help solve the continuing shortage of organs needed for transplants. According to the web site organdonor.gov, more than 107,000 people in the U.S. are on waiting lists for organ donations, with 17 people expected to dies each day waiting for a transplant. And while some 39,000 transplants were performed in 2020, only 3 in every 1,000 deaths in the U.S. allow for organ harvesting, due to circumstances of the death or no advance permission from the patient.

eGenesis’s technology uses the gene-editing technology Crispr to enable transplanting organs from pigs, which have organs much the same size and functioning as humans, a process called xenotransplantion. Crispr, short for clustered regularly interspaced short palindromic repeats, is derived from bacterial defense systems that use RNA to guide genome-cutting enzymes to precise locations to make the desired edits.

In this case, eGenesis uses Crispr to remove serious obstacles preventing xenotransplantion. One obstacle is the presence of the porcine endogenous retrovirus in pigs, a virus that infects and spreads through human cells. As reported in the journal Science in August 2017, researchers from eGenesis and Harvard edited the genomes in pigs to deactivate the gene responsible for the virus, and enable the deactivated virus to be passed on to future generations. The company also employs Crispr to remove other genetic-based incompatibilities from pig organs that provoke a damaging immune-system response.

Lead programs: replacement kidneys and islet cells

eGenesis is a six year-old company co-founded by Luhan Yang, then a postdoctoral researcher in Church’s lab. Yang has since moved on to start another business, using Crispr for regenerative medicine, while Church continues as a scientific adviser to eGenesis. Science & Enterprise has followed the company since its founding, reported on its first and second venture funding rounds of $38 million and $100 million respectively.

The company’s two lead programs, both in preclinical stages, are developing genetically edited kidneys and islet cells in the pancreas needed by people with type 1 diabetes, an autoimmune condition that attacks islet cells. Also in preclinical development are genetically edited hearts and livers, as well as livers for perfusion, a procedure to separate the liver’s blood supply to allow for high doses of anti-cancer drugs.

eGenesis’s third venture round is raising $125 million from new and previous life science and health care investors. The company says it plans to use the proceeds for advancing its kidney and islet cell programs to human proof-of-concept studies, as well as furthering and scaling-up its gene-editing technology to meet good manufacturing practice standards.

New investors in eGenesis are Farallon Capital ManagementPolaris Partners, HBM Healthcare InvestmentsInvus, Samsara BioCapital, LifeSci Venture Partners, Irving InvestorsCatalio Capital Management, SymBiosisAltium Capital, Monashee Investment Management, and Osage University Partners. Current investors taking part in the round are Leaps by Bayer, Fresenius Medical Care Ventures, ARCH Venture Partners, Wellington Partners, Khosla Ventures, and Alta Partners.

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