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The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.
Within the emerging innovation stage, DNA chips, tissue culturing automation, and mass spectrometry analysis are disruptive technologies that are in the early stages of application and should be tracked closely. However, not all innovations are equal nor do they follow a constant upward trend.
Using a common cloning technique, researchers removed the genetic material from one female’s eggs and replaced them with nuclear DNA from the skin cells of another. Then with a novel chemical cocktail, they nudged the eggs to lose half their new sets of chromosomes and fertilized them with mouse sperm. Read the rest…
The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Microenvironment Management : Optimizing the tumor microenvironment to enhance TIL efficacy remains a critical focus of research efforts.
While it remains unclear why some people become more gravely ill than others when infected with the SARS-CoV-2 virus that causes COVID-19, researchers have found that an immune deficiency may be part of it. Two recent studies have shown that individuals who lack an important immune factor may have reduced ability to fight the virus.
Lung cancer is the most common cancer in men and the third most common cancer in women, according to global lung cancer statistics by the World Cancer Research Fund. Cancerous cells and tumors release small fragments of DNA into the bloodstream called circulating tumour DNA (ctDNA). Photo source: Inivata.
DNA cloning refers to the process of generating multiple copies of a particular DNA segment. DNA and Gene Cloning involves the isolation of a DNA sequence of any species ( often a gene ) and its insertion into a vector to enable growth without any alteration in the original DNA sequence.
Once someone is infected with HIV it stays with them for life thanks to the retrovirus’s ability to inject its DNA code into the host. Khalili said: “This transformative financing will accelerate and support the research we have developed over the past decade. The post Could CRISPR cure HIV?
From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. In this blog, we discuss some of these new medical devices of 2024 that have improved patient outcomes and enhanced quality of life worldwide.
Devex’s global COVID-19 funding dashboard recorded $172 million invested in vaccine research between 1 January 2020 and 27 June 2020. Research into the therapeutic use of mRNA had been ongoing for decades prior to the COVID-19 pandemic. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.
BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.
This is the first time that research scientists can conduct oncology research with Foundation Medicine’s comprehensive genomic profiling in their own laboratories to gain meaningful genomic insights and deepen their understanding of cancer biology. Roche today announced that it has launched the AVENIO Tumor Tissue CGP Kit.
Last year, the company signed its first major multi-million dollar research collaboration with Gilead Sciences to target liver disease, nonalcoholic steatohepatitis (NASH). The platform applies machine learning, human genetics, and functional genomics to generate predictive in vitro models that provide insights into disease progression.
Messenger ribonucleic acid (mRNA) is a single-stranded molecule that is complementary to a gene’s DNA. It is important in the process of protein synthesis because mRNA is responsible for transferring genetic information from DNA to ribosomes, which then decodes the genetic information into a protein.
Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.
Molecular diagnostic tests refer to tests intended to detect specific sequences in human genomic samples, such as DNA or RNA, in order to diagnose a particular disease. It is worth mentioning that molecular diagnostics is a subset of the broader in vitro diagnostics market.
The current standard of care for GBM consists of de-bulking surgery followed by combined treatments with fractionated ionizing radiation (IR) and the DNA alkylating agent temozolomide (TMZ). .
Many drugs fail in clinical trials because of their low blood brain barrier permeability. Lantern’s A.I.
Overview of Cell Free Systems Cell-free systems are in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.
Despite the effectiveness of anti-retroviral therapy (ART) in significantly improving health, quality of life and reducing mortality among HIV-positive individuals, new research shows that persistent infections may be due to the ability of the virus to take refuge in distinct subsets of immune T cells.
In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 FDA Emergency Use Authorization Statement.
In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. .
Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).
This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care. Liquid biopsies, for example, allow non-invasive monitoring of cancer progression and response to treatment by analyzing circulating tumor DNA (ctDNA) in blood samples.
In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. It is important to highlight that IVT mRNAs are structurally similar to natural mRNAs and can be used to express proteins through genetic engineering.
WeiQi Lin, MD, PhD, executive vice president of research & development and principal scientist, DURECT Corporation. Lin has made several transitions throughout her career, from being a clinician at an academic center, to academic research, to heading business development in industry. Motivations for Transition. Key Moments.
In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.
In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. Pfizer oral treatment remains available to eligible U.S. NEW YORK, December 20, 2022 -- Pfizer Inc. NYSE: PFE) announced today that the U.S.
In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions. This agreement, negotiated with the Health Emergency Preparedness and Response Authority (HERA) of the EC, is in addition to the bilateral agreements Pfizer has previously signed with 17 EU Member States. .
This diagnostic assay works on the principle of in vitro nucleic acid amplification using real-time transcription-mediated amplification (TMA) technology. The Aptima CMV Quant Assay helps to detect changes in the viral load of the transplant patient to understand the response of the individual to anti-CMV treatment.
Enzymatic DNA production company Touchlight have augmented its DNA production capabilities with a newly announced expansion to its London facilities. Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines.
Hans Bunschoten, chief strategy officer, Cerba Research: “Cerba Research and Viroclinics-DDL have a lot of synergies” The discrepancy is magnified in pivotal studies with a 76.1% This may sound obvious, but it is still a major hurdle in drug development. of the clinical trial population globally.
Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The price of that prize is incalculable.
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