Disruptive technology!BD invested in the diagnosis of a new generation of broad-spectrum drug-resistant bacteria

2022-06-06 0 By

Source: Appliance Home, without authorization, shall not be reproduced in any form, and can be reproduced 24 hours later.On February 9, Day Zero Diagnostics announced the closing of a $25 million funding round,Backed by medical giants BD, Panacea Venture, Hongkou Capital, Triventures and Golden Seeds.BD was the first to join the ranks of Day Zero investors and sent Brooke Story, its president of Integrated diagnostic Solutions, to join Day Zero’s board of directors as an observer.Antibiotic resistance is one of the greatest current threats to global health, food security and development.Antibiotic resistance is also known as a “hidden epidemic” after a recent analysis showed that at least 1.2 million people died from ANTIBIOtic-resistant infections worldwide in 2019, but the true figure could be as high as 5 million, far surpassing infectious diseases such as AIDS and malaria.To combat this challenge, the company has developed a high-throughput rapid diagnostic method based on sequencing that quickly diagnoses infections directly from blood samples, without waiting for culture results, and can identify the species and antibiotic resistance characteristics of bacterial pathogens within hours.In contrast, existing methods require two to five days to provide the same information, given that the death rate from severe infection increases by 8% per hour, and the life expectancy of patients with septic shock is only 24 hours, rapid diagnosis will create great clinical value.In a telling description of Day Zero’s technology, The company’s Asian-american founder and CHIEF executive, Jong Lee, says that extracting information about infections from blood is like looking for a needle in a haystack because of the vast amount of human DNA in the background.Other companies trying to diagnose infections from blood are taking technical routes – such as using biomarker probes that act like magnets to find dropped needles.Lee says that while this is feasible, it only identifies target biomarkers and provides very limited information — not the entire genome of a bacterial pathogen.Day Zero takes the opposite approach. “We remove all the hay from the ground, and the needles that fall on the ground [the bacterial pathogens that drive the infection] are left.”Brooke Story of BD said that the diagnosis of infectious diseases is in transition, genome sequencing will play an important role in the future, and Day Zero’s technology will have a huge space to play.Jong Lee, CEO and co-founder of Day Zero Diagnostics, said at the launch:”The continued support of our existing investors and the participation of new investors, including BD as a leader in infectious disease diagnostics, is a strong vote of confidence in the technology we have built and our vision for the future of genome sequencing in infectious disease diagnostics.”Antibiotic resistance occurs naturally, but the abuse and misuse of antibiotics in humans and animals can accelerate the process.Resistance leads to a growing number of infections (such as pneumonia, tuberculosis, gonorrhea and salmonellosis) that are harder to treat, and a decline in the effectiveness of antibiotics used to treat infections, resulting in longer hospital stays, higher medical costs and higher mortality rates.The World Health Organization warns that without urgent action, we are heading for a post-antibiotic era, where common infections and minor injuries will once again kill.At the moment, clinicians are often “flying blind”, using a “carpet bombing” approach to try to control serious infections, according to The firm’s founder, Jong Lee.Day Zero Diagnostics has developed a series of tools to identify and characterize these bacterial diseases as early as possible to quickly determine which drugs are best suited to fight antibiotic-resistant infections.Day Zero’s BacDetect platform first determines if a blood sample contains any bacterial DNA, and if it does, processes it using Blood2Bac technology it developed.Blood2Bac is the company’s core technology, because there is a billion times more human DNA in a blood sample than bacterial DNA, so getting information about an infection from blood is like looking for a needle in a haystack.Blood2Bac is an ultra-enriched bacterial DNA process that converts samples into final diagnostic readings, where there will be much more sequencing data for bacterial DNA than for human DNA.Patented Blood2Bac has so far been validated in more than 50 bacterial pathogens with clinically relevant concentrations of 1 CFU/mL blood, enabling in-depth whole-genome sequence coverage of bacterial pathogens directly from clinical blood samples.The company has also built a large microbial database called MicrohmDB, which combines whole-genome sequencing data from clinically relevant pathogens with phenotypic derived drug resistance and sensitivity characteristics, making it one of the largest data sets of its kind in the world.MicrohmDB was used to train its Keynome algorithm, which was able to predict drug resistance curves in genome sequences and identify different bacterial species.In just a few hours, Day Zero’s diagnostic system relies on high-throughput sequencing and Keynome algorithms to determine the pathogen, which antibiotics won’t respond to it, and how other treatments will affect it.The Boston Medical Center Rapid Bacterial Identification Trial (BRABIT) is a pilot, single-center study presented on IDWeek by Nina H. Lin, PhD, assistant professor at Boston University School of Medicine and director of the Division of Clinical Research in Infectious Diseases at Boston University.The analysis showed that the culture-free assays used by Day Zero to determine the presence of bacterial infections and their species were consistent with clinical blood cultures in 96% of the samples.Interim analysis also showed that the Day Zero assay may be more sensitive than culture-based diagnosis, confirming infection even when blood cultures fail to grow on the same Day.In addition, Day Zero has had no false positive results so far.The company is currently in the process of integrating its testing capabilities into the equipment of the microbiology laboratory.Once the design is finalized, they will seek FDA approval.Day Zero was founded in 2016 by a group of clinicians and scientists from Harvard University and Massachusetts General Hospital, based in Boston, US.The company has now raised over $33 million in venture capital equity financing and an additional $10 million in non-dilutive capital.Day Zero’s name also encapsulates its vision of being able to use its whole genome sequencing and algorithms to give patients with severe infections the most effective antibiotic treatment on the first Day of admission (Day Zero).On September 27, 2021, the company received the Disruptive Technology Award at the American Society for Clinical Chemistry (AACC) annual Meeting.According to 2013 data, the number of drug-resistant infections in U.S. hospitals has increased two to four times since 2008.And China consumes 10 times more antibiotics per person than the United States per year.According to data, 80% of hospitalized patients in China receive antibiotics.Antibiotic resistance has become an escalating global crisis, with the spread of resistant bacteria outpacing the development of new antibiotics.Infections caused by antibiotic-resistant bacteria are more dangerous for patients and more difficult and expensive to treat.They often require extended hospital stays and more expensive and toxic alternative treatments.As drug-resistant bacteria become more common, so will deaths from life-threatening infections such as sepsis, with antibiotic resistance already responsible for at least 700,000 deaths a year and projected to cause more than 10 million deaths annually by 2050.As things get worse, more and more companies are jumping into this field.Israel’s MeMed, considered a Day Zero competitor, also raised $93 million in January for its bedside BV test and Key platform, which can distinguish between bacterial and viral infections to help avoid overuse of antibiotics.Late last year, the company announced the results of a study that included more than 1,000 children who were admitted to hospital emergency rooms with unexplained fevers and respiratory infections.Prospective studies have found that the company’s 15-minute blood test can accurately determine whether bacteria are the primary cause of fever, while showing that it can reduce the overuse of antibiotics in virus-infected children.The findings are in the journal Clinical Microbiology and Infection.In 2018, scientists at the Center for Infection and Immunity (CII) at Columbia University’s Mailman School of Public Health developed a medical diagnostic platform called BacCapSeq.It is the world’s first diagnostic platform that can simultaneously screen all known human pathogens, as well as markers of virulence and antibiotic resistance.BacCapSeq contains 4.2 million genetic probes, each of which combines specific sequences to detect the characteristic DNA of all 307 pathogenic bacteria, as well as biomarkers of antibiotic resistance and toxicity.When certain bacteria and biomarkers are present in samples, a magnetic reaction “pulls” them out and identifies their unique sequences.Researchers at ETH Zurich, University Hospital Basel and the University of Basel have also developed a method that uses mass spectrometry data to identify signs of antibiotic resistance in bacteria up to 24 hours in advance.The mass spectrometer analyzes thousands of protein fragments in each sample, then creates individual fingerprints of bacterial proteins.The team extracted the mass spectra of more than 300,000 individual bacteria from four laboratories in northwestern Switzerland and linked these to the results of corresponding clinical resistance tests, building the largest data set to date combining mass spectrometry data with antibiotic resistance information.With the use of antibiotics since World War II, especially the abuse of low doses of antibiotics, pathogen resistance has greatly increased, and many previously used drugs have weakened or even become ineffective, greatly increasing the pressure of new drug development.In China, due to the extremely easy purchase of antibiotics, combined with many negative factors such as environmental hygiene and food safety, some people with weak immune systems choose to buy some broad-spectrum antibiotics for long-term use in order to avoid serious respiratory tract infection, intestinal infection and other diseases.However, long-term administration of small doses provides an excellent screening and mutagenesis environment for pathogens, in which low concentrations of antibiotics can weed out pathogens with very weak drug resistance.At the same time, due to long-term drug use, the patient’s own immune system degrades, the consequence is that long-term drug users after a period of time, the effect of the drug is weakened, but more prone to illness.As in this outbreak, vaccines have been developed, but the virus is evolving faster.The tug of war between humans and bacteria will continue much longer than the COVID-19 pandemic.How to fight antibiotic resistance is a difficult problem that enterprises, medical institutions and even the whole society need to face together.