Microdrop Blood Testing Device is Validated by Scientific Community

ALEX KEOWN | April 15, 2019 | 129 views

These days, when someone mentions blood-testing diagnostics systems that rely on a few drops of blood, first thoughts may head directly to the alleged fraud committed by the founder and chief executive officer of Theranos, Elizabeth Holmes. Homes faces up to 20 years in prison for allegedly defrauding investors at Theranos. For years Holmes promised a diagnostic technology that could function on a single drop of blood but never delivered on her promises. All the while, the company raised hundreds of millions of dollars from investors and the diagnostics that were performed, led to numerous lawsuits over the tens of thousands of results that had to be voided.

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Genetics Society of America

The mission of the Genetics Society of America (GSA) is to deepen our understanding of the living world by advancing the field of genetics. Fostering an international community of geneticists by promoting interaction among geneticists (including microbial, plant, animal, human, and population and theoretical geneticists) while cultivating a community of thought leaders in the field.

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MedTech

Top 10 biotech IPOs in 2019

Article | July 20, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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MedTech

Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | July 11, 2022

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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Medical

Closing bacterial genomes from the human gut microbiome using long-read sequencing

Article | July 14, 2022

In our lab, we focus on the impact of the gut microbiome on human health and disease. To evaluate this relationship, it’s important to understand the particular functions that different bacteria have. As bacteria are able to exchange, duplicate, and rearrange their genes in ways that directly affect their phenotypes, complete bacterial genomes assembled directly from human samples are essential to understand the strain variation and potential functions of the bacteria we host. Advances in the microbiome space have allowed for the de novo assembly of microbial genomes directly from metagenomes via short-read sequencing, assembly of reads into contigs, and binning of contigs into putative genome drafts. This is advantageous because it allows us to discover microbes without culturing them, directly from human samples and without reference databases. In the past year, there have been a number of tour de force efforts to broadly characterize the human gut microbiota through the creation of such metagenome-assembled genomes (MAGs)[1–4]. These works have produced hundreds of thousands of microbial genomes that vastly increase our understanding of the human gut. However, challenges in the assembly of short reads has limited our ability to correctly assemble repeated genomic elements and place them into genomic context. Thus, existing MAGs are often fragmented and do not include mobile genetic elements, 16S rRNA sequences, and other elements that are repeated or have high identity within and across bacterial genomes.

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Selexis Cell Line Development Strategies

Article | February 11, 2020

In today’s biotechnology landscape, to be competitive, meet regulations, and achieve market demands, “we must apply Bioprocessing 4.0,” said Igor Fisch, PhD, CEO, Selexis. In fact, in the last decade, “Selexis has evolved from cloning by limiting dilution to automated cell selection to nanofluidic chips and from monoclonality assessment by statistical calculation to proprietary bioinformatic analysis,” he added. Single-use processing systems are an expanding part of the biomanufacturing world; as such, they are a major component of Bioprocessing 4.0. “At Selexis, we use single use throughout our cell line development workflow. Currently, we have incorporated single-use automated bioprocessing systems such as ambr® and the Beacon® optofluidic platform for accelerated cell line development. By using these systems and optimizing our parameters, we were able to achieve high titers in shake flasks. Additionally, the Beacon systems integrate miniaturized cell culture with high-throughput liquid handling automation and cell imaging. This allows us to control, adjust, and monitor programs at the same time,” noted Fisch.

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Spotlight

Genetics Society of America

The mission of the Genetics Society of America (GSA) is to deepen our understanding of the living world by advancing the field of genetics. Fostering an international community of geneticists by promoting interaction among geneticists (including microbial, plant, animal, human, and population and theoretical geneticists) while cultivating a community of thought leaders in the field.

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Emergent BioSolutions Announces Initiation of Phase 3 Cinical Trial of Hyperimmune Intravenous Immunoglobulin to Treat COVID-19 Patients

Emergent BioSolutions | October 09, 2020

NIAID has initiated a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including Emergent’s COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19. Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure. Emergent BioSolutions, Inc. Inc. (NYSE:EBS) today announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease (COVID-19). The INSIGHT-013 clinical study called “Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC),” is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study will evaluate the safety, tolerability, and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of four hyperimmune globulin products, which includes Emergent’s COVID-HIG, with a background therapy of remdesivir in all groups.

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Dynavax and Sinovac Partner to Develop COVID-19 Vaccine Candidate

BioSpace | April 16, 2020

California-based Dynavax Technologies has entered the race alongside Sinovac Biotech to develop a vaccine candidate against COVID-19. The two companies will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018. Dynavax’s CpG 1018 is the adjuvant used in its Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration in 2017. Earlier this month, Dynavax donated 10,000 doses of Heplisav-B to help protect healthcare professionals on the front lines of the COVID-19 response against hepatitis B, a deadly virus spread through contact with infected blood and bodily fluids, which can live on surfaces for at least seven days. The use of an adjuvant in a vaccine is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose. That will allow more vaccine doses to be produced, which therefore contributes to the protection of people. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which it has seen in Heplisav-B. CpG 1018 provides a well developed technology and a significant safety database, potentially accelerating the development of a coronavirus vaccine, the company said.

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Rgenta Therapeutics Launches with $20 Million Seed Investment

BioSpace | April 02, 2020

Rgenta Therapeutics, a new biotechnology company focusing on developing RNA-targeting medicines for historically undruggable disease-relevant targets, announced today that it closed a $20 Million seed investment, co-led by Boehringer Ingelheim Venture Fund and Matrix Partners China. Rounding out the series seed syndicate are two additional investors, Kaitai Capital and Legend Star Fund. The company has assembled a world-class team of small-molecule drug developers and an exceptional Scientific Advisory Board in the fields of genomics and RNA biology.

Read More

Emergent BioSolutions Announces Initiation of Phase 3 Cinical Trial of Hyperimmune Intravenous Immunoglobulin to Treat COVID-19 Patients

Emergent BioSolutions | October 09, 2020

NIAID has initiated a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including Emergent’s COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19. Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure. Emergent BioSolutions, Inc. Inc. (NYSE:EBS) today announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with coronavirus disease (COVID-19). The INSIGHT-013 clinical study called “Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC),” is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study will evaluate the safety, tolerability, and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2, the virus that causes COVID-19. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of four hyperimmune globulin products, which includes Emergent’s COVID-HIG, with a background therapy of remdesivir in all groups.

Read More

Dynavax and Sinovac Partner to Develop COVID-19 Vaccine Candidate

BioSpace | April 16, 2020

California-based Dynavax Technologies has entered the race alongside Sinovac Biotech to develop a vaccine candidate against COVID-19. The two companies will evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018. Dynavax’s CpG 1018 is the adjuvant used in its Heplisav-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration in 2017. Earlier this month, Dynavax donated 10,000 doses of Heplisav-B to help protect healthcare professionals on the front lines of the COVID-19 response against hepatitis B, a deadly virus spread through contact with infected blood and bodily fluids, which can live on surfaces for at least seven days. The use of an adjuvant in a vaccine is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose. That will allow more vaccine doses to be produced, which therefore contributes to the protection of people. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which it has seen in Heplisav-B. CpG 1018 provides a well developed technology and a significant safety database, potentially accelerating the development of a coronavirus vaccine, the company said.

Read More

Rgenta Therapeutics Launches with $20 Million Seed Investment

BioSpace | April 02, 2020

Rgenta Therapeutics, a new biotechnology company focusing on developing RNA-targeting medicines for historically undruggable disease-relevant targets, announced today that it closed a $20 Million seed investment, co-led by Boehringer Ingelheim Venture Fund and Matrix Partners China. Rounding out the series seed syndicate are two additional investors, Kaitai Capital and Legend Star Fund. The company has assembled a world-class team of small-molecule drug developers and an exceptional Scientific Advisory Board in the fields of genomics and RNA biology.

Read More

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