Nov 14, 2019
Burlingame, Calif., November 14, 2019 — HostDx Fever Test Reads the Immune System to Rapidly Diagnose Acute Infections at Point of Care. Inflammatix, a pioneering molecular diagnostics company, announced today an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its HostDx™ tests. Under the contract, Inflammatix will receive $6 million in the first phase of a cost-sharing contract worth up to $72 million based on achieving certain milestones.
The new contract will advance development and commercialization of Inflammatix’s simple sample-to-answer, point-of-care HostDx test system, which will produce results in under 30 minutes. The first phase of work will focus on the novel HostDx Fever test. The HostDx Fever test “reads” gene expression patterns in the immune system to quickly identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine whether to prescribe antibiotics. The HostDx Fever test will be run from a fingerstick blood sample and will be used primarily in primary care, urgent care and other outpatient clinical settings. Today, an estimated 30 percent of antibiotics are inappropriately prescribed to patients with infections because their infections are not obviously bacterial or viral in origin.
“We are thrilled to receive this funding from BARDA, which will enable us to advance our HostDx Fever test into the clinic where it will help physicians quickly diagnose infections so they can get the right treatments to the right patients. This ability is key to combatting antibiotic resistance, which is one of the most pressing public health challenges of our time,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “Through this public-private sector partnership, we will move precision medicine to the point of care, where it can have an immediate impact on patient outcomes.”
Current methods for diagnosing infections are too slow and often inaccurate, resulting in delayed or inappropriate treatment. Infections are often blindly – and incorrectly – treated with antibiotics, which contributes to antibiotic resistance. Each year at least 2 million Americans become infected with bacteria that are resistant to antibiotics and at least 23,000 die as a direct result.
The contract may optionally support two additional Inflammatix tests: HostDx Sepsis and HostDx FeverFlu. HostDx Sepsis is a blood-based test that will rapidly diagnose infections in patients in emergency department or other hospital settings and determine which patients are likely to have or develop sepsis. HostDx FeverFlu will be performed on nasal swab samples and will combine traditional influenza testing with host-response biomarkers.
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in 20-30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford-StartX Fund and Think.Health Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00034.
Media Contacts
For Inflammatix:
Tracy Morris
[email protected]
650-380-4413
Aug 6, 2019
Burlingame, Calif., August 6, 2019 — Inflammatix, a molecular diagnostics company that is reimagining diagnostics, announced today that it has received the American Association for Clinical Chemistry’s (AACC) Disruptive Technology Award for its rapid HostDx™ tests, which read the immune system to improve diagnosis of acute infections and sepsis. The award was based on the company’s presentation during the 71st AACC Annual Scientific Meeting, which is being held August 4-8 in Anaheim, Calif.
“We are extremely honored to receive this prestigious award, which recognizes the power of our proven technology to transform diagnosis of acute infections and sepsis,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “We believe our rapid HostDx tests will enable physicians to more quickly get the right treatments to the right patients, improving patient outcomes and ultimately reducing the global health burdens of antibiotic resistance and sepsis.”
Inflammatix’s first test, HostDx Sepsis, will use proprietary algorithms to read the immune system’s response to infection. The test measures the expression of multiple immune genes to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. In contrast, while traditional diagnostic approaches look for blood-based pathogens, most infections – and nearly half of sepsis cases – are negative for bloodstream pathogens. Inflammatix’s technology is proven in dozens of studies involving over 2,400 patients and published in leading peer-reviewed journals. The company is developing a proprietary cartridge-based system that will produce rapid results at or near the point of care in 30 minutes or less and plans to seek FDA clearance for the HostDx Sepsis test.
Each year in the United States alone, 20 million patients are assessed for acute infections and sepsis in emergency department and other hospital settings. Sepsis, a life-threatening condition in which the body’s immune system becomes dysregulated fighting an infection, kills more than 250,000 people in the United States each year and is estimated to cause or contribute to over five million deaths worldwide annually.
AACC’s Disruptive Technology Award recognizes innovative testing solutions that improve patient care through diagnostic performance or access to high quality testing. Inflammatix was one of three finalists selected to present to a panel of expert judges during a special session of the AACC meeting. The company was selected based on its technology’s clinical validity, patient impact, market opportunity, business model, competitive analysis, intellectual property strength, regulatory plan, team strength and stage of development.
Inflammatix also received the Audience Choice award based on the audience’s votes for their favorite technology.
About Inflammatix
Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in 20-30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford-StartX Fund and Think.Health Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
Media Contacts
For Inflammatix:
Tracy Morris
[email protected]
650-380-4413
May 16, 2019
Burlingame, Calif., May 16, 2019 — Inflammatix announced today that it has been named a finalist for the American Association for Clinical Chemistry’s (AACC) Disruptive Technology Award for its rapid HostDx™ tests, which read the immune system to improve diagnosis of acute infections and sepsis. Inflammatix is one of three finalists that will present its technology at the 71st AACC Annual Scientific Meeting in Anaheim, Calif., during a special session on August 5, 2019.
“We are honored to be selected as a finalist for this prestigious award,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “This recognition underscores the power of our approach of evaluating the body’s immune system to diagnose infections and sepsis faster and more accurately than current methods.”
Inflammatix’s first test, HostDx Sepsis, uses proprietary algorithms to diagnose the host response to infection. Specifically, it measures the expression of multiple immune genes to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. In contrast, traditional diagnostic approaches look for blood-based pathogens, but most infections – and nearly half of sepsis cases – are negative for bloodstream pathogens. Inflammatix is developing a proprietary cartridgebased point-of-need system that will produce rapid sample-to-answer results in 30 minutes or less and plans to seek FDA clearance for the HostDx Sepsis test.
Sepsis, a life-threatening condition in which the body’s immune system becomes dysregulated fighting an infection, kills more than 250,000 people in the United States each year and is estimated to cause or contribute to over five million deaths worldwide annually.
AACC’s Disruptive Technology Award recognizes innovative testing solutions that improve patient care through diagnostic performance or access to high quality testing.
About Inflammatix
Inflammatix is a molecular diagnostics company that is developing rapid tests that read the immune system, enabling improved patient care and reducing major public health burdens. The company’s initial focus is on acute bacterial and viral infections and sepsis, where its HostDx™ tests will allow physicians to quickly get the right treatments to the right patients, reducing morbidity and mortality, health system costs, and antibiotic resistance. While current tests diagnose infections by “finding the bug” – an approach that misses the 70% of infections that never enter the bloodstream – Inflammatix evaluates the body’s immune system response to provide more accurate and faster diagnosis. Its scientific approach has been validated in over 20 independent cohorts involving over 1,000 patients and published in leading medical journals. The privately held, Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford-StartX Fund and Think.Health Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
Media Contacts
For Inflammatix:
Tracy Morris
[email protected]
650-380-4413
Feb 13, 2019
Diagnostics for acute infections and sepsis typically focus on “finding the bug,” but most patients with infections do not have pathogens in their bloodstream.
Companies like Inflammatix are committed to this issue, using host-response diagnostics to read a patient’s immune system. Inflammatix’s CEO, Tim Sweeney, believes novel technologies coupled with machine learning are the answer for physicians when seeing a patient they suspect of having an acute infection.
On behalf of Diagnostics World News, Kaitlin Kelleher spoke with Sweeney about the challenges in developing these types of diagnostics, and what downstream effects they have on the healthcare and patient care systems.
Diagnostics World News: Novel technologies for host response are popping up left and right. Is this a technology that will finally be able to quickly and accurately diagnose sepsis and other acute infections at the point of care?
Tim Sweeney: The short answer is, yes, I think that measuring the host response is the technology that can answer the clinical questions a physician has when they see a patient suspected of having an acute infection or sepsis. The longer answer is that people have been trying to do this for literally decades and have not yet been successful. I think we have to have a dose of humility when discussing where the field is now and where it’s likely to go.
When we at Inflammatix have surveyed physicians, there are really three key questions that come up for patients suspected of an acute infection: Should the patient be treated with antibiotics? What downstream diagnostics are necessary? What level of care (e.g. can the patient be sent home or requires admission)? With those three questions, you can basically get through the next several hours of the patient’s clinical care and move on to the next patient in the queue. The host response is uniquely suited to answer those questions where pathogen-based tests don’t always get the whole picture.
We know that the majority of patients seen in an emergency department who are ultimately judged to have bacterial infections do not have a bloodstream infection. So patients come in and they’re suspected of maybe having an infection, but by the time all of the microbiology and the imaging, etc., is back, only about 10% of the patients who are eventually judged to have a bacterial infection anywhere in the body actually had positive blood cultures. This means that technologies that detect infections by looking for bacteria in the blood are reasonably accurate as a rule-in test but are terrible as a rule-out test.
The host response has the promise of being able to say, “Let’s understand why this patient is having symptoms.” In other words, the patient’s symptoms are due to the immune response, and that immune response is caused by something. Measuring host response can tell us what that something is, whether it’s bacterial or viral or maybe noninfectious. Maybe it’s a complication of surgery or a blood clot or any of the other noninfectious causes of acute inflammation. Then, in addition to getting the diagnosis right, of being able to say, yes, the patient has a bacterial infection, we can also gauge how severe that host response is in terms of whether the patient has sepsis because sepsis, ultimately, is an immune phenomenon. So the host response is the right place to look for both diagnostic and risk-stratification information.
All of that being said, a single host biomarker is not up to the task of answering these key questions simultaneously. If there was some single protein that had these qualities, we would have found it by now. In addition, frankly, we’re really answering two separate questions. One is, is there an infection present? The other is, how severely sick is this patient? One biomarker just cannot produce two separate axes of information. So the field is moving more broadly to multi-marker diagnostic panels for diagnosing and prognosing acute infections and sepsis. The caveats then are, first, those multi-marker panels have to be comprised of robust individual markers. Then, second, (and this historically has been the biggest challenge) they also have to have algorithms that integrate multiple independent biomarkers into a single clinically useful score. Overcoming both of these challenges is difficult, but that’s where Inflammatix has made a lot of progress.
So I think the answer to your original question of whether this is the right technology, is yes. Resoundingly. I don’t know that we’re there yet across the industry, but I think that there are teams (like ours) who have demonstrated an ability to select biomarkers focused on answering relevant clinical questions, and then confirmed their external validity. This shows substantial proof of concept that host response really can be a killer app for point of care diagnostics.
You’ve mentioned that we’re not there yet. What are the biggest challenges to developing these types of diagnostics?
Obviously, some are those that I just mentioned, which are choosing the right biomarkers and getting the algorithms right. Another is putting the results into a format that makes sense for the clinical question that a clinician is trying to answer. Getting the clinical outputs right is something that takes a lot of clinical understanding, clinical domain expertise, combined with world-class machine learning. We do this through understanding the clinical settings of our training data, combined with cutting edge techniques in building stable, generalizable classifiers. Those two together make the biggest difference in our ability to generate a stable classifier.
Another challenge is in making sure that the test fits into workflow, which of course depends on the clinical question. If we really want a test to fit in an emergency department at the point of care, the turnaround time for that technology should be probably less than 30 minutes. A physician needs to make a decision within an hour, and we still have to get the sample drawn and get the test report to the physician with them to have time to spare to make that decision about whether to treat. That being said, not every patient needs to be treated within an hour. In fact, the US healthcare system probably sees 20 million patients a year in a hospital setting where the patient is primarily suspected of having an acute infection. For the vast majority of those patients, it may be perfectly acceptable to send a sample down to a clinical lab and have an answer in more like 60 minutes. So translating host response technologies into the clinic depends on what market is being approached. Many scenarios are valid, but of course the faster turnaround times require more advanced technologies.
In any case, for host response diagnostics, the challenges of getting multiple measurements from multiple analytes correct in a cartridge-based format takes some development time. We, among others, are developing technologies that will meet that market need. But it’s historically proved challenging to get multiplex measurements in cartridge-based formats. That being said, I think one of the advantages that we have now is that others have come before us. Several cartridge-based multiplex solutions have been brought to market, and the lessons learned from those development processes are now known in the industry. In setting out to design a next-generation point of care diagnostic test system, we have been able to leverage those lessons. We expect to be able to build faster and more cost-effectively than historical averages, while increasing the chance that our test system will be robustly adopted either at the point of care or in the clinical lab setting.
When you do have these technologies in the clinic, what downstream effect will we see on patient care and our healthcare system?
I will just give some conjecture here because of course we don’t really know. I think that the advent of procalcitonin brought with it the promise of a massive reduction in unnecessary antibiotic use and better adjudication of level of care. Unfortunately, its accuracy level didn’t really support that promise. We’ve seen multiple studies in the US, at least, of procalcitonin not really impacting care. So I think we have to be guarded in understanding how best the host response may ultimately change the healthcare system. On the other hand, procalcitonin does do a reasonable job at reducing antibiotics if measured in a guideline-based system where physicians are adhering to that guideline. It’s undoubtedly true that early adopters of host-response diagnostics will be successful if they implement these technologies as part of an overall diagnostic or antibiotic stewardship framework. In general, the promise of the host response is a decrease in the rate of inappropriate antibiotic prescriptions, a decrease in the rate of patients who progress to sepsis, and reduced unnecessary care. Improvements in screening should reduce both false positive and false negative results.
I think, if you look five or 10 years out, the whole field of infectious disease diagnostics will really have changed to encompass three separate, game-changing technologies. I think the patient pathway will have, up front, a host-response screening test that’s broadly used for anybody who has symptoms of acute inflammation. This will inform a physician what downstream diagnostics are needed, and whether to prescribe antibiotics. If the host-response screen is positive for bacterial infection, those patients may then deserve one of the ultra-rapid direct-from-blood pathogen identification and antibiotic susceptibility tests (ASTs). So if the host response screening upfront is positive for bacterial infection you can start empiric antibiotics, and then the downstream phenotypic AST test says whether you can narrow your antibiotic choices. I think that will cover the vast majority of patients.
In those patients who remain very ill despite that early one-two step of the host response screening followed by phenotypic AST, I think that’s where clinical metagenomics and deep sequencing will have value. Diagnosing those rare patients that are very sick but are not adequately diagnosed by either of the first two technologies. I think those three technologies together can answer all of the key diagnostic questions in patients in a sepsis care pathway. These are, initially, does the patient need antibiotics, then what downstream diagnostics, and what level of care? If it’s bacterial, it goes to rapid ID and AST. If they’re still sick despite treatment, that’s when clinical metagenomics will really make sense. So a care pathway progresses from a broad, fast, general solution through to more niche high-value but expensive solutions. I think that’s the spectrum that we’ll end up seeing in place over the next five to 10 years.
Editor’s note: Kaitlin Kelleher, Conference Producer at Cambridge Healthtech Institute, is planning a conference dedicated to Molecular Diagnostics for Infectious Disease next month at the Molecular Medicine TriConference, March 10-15 in San Francisco. Sweeney will be speaking on the program; their conversation has been edited for length and clarity.
Originally published in Diagnostics World, 2019.
Oct 4, 2018
Burlingame, Calif., October 4, 2018 — Inflammatix today announced that it will present findings from two studies demonstrating the ability of its HostDx™ Fever test to distinguish bacterial from viral infections on multiple rapid laboratory platforms that can deliver results in under 30 minutes. The new data will be presented at the Infectious Diseases Society of America (IDSA) IDWeek™ 2018 taking place October 3-7, 2018, in San Francisco.
The HostDx Fever test is designed to help physicians differentiate acute bacterial and viral infections quickly and accurately in outpatient and urgent care settings. It uses gene expression data and bioinformatics to read the immune system response, rather than look for specific pathogens. The new data at IDWeek 2018 will demonstrate the company’s successful translation of its core technology onto rapid isothermal and PCR laboratory platforms, which can enable rapid results at or near the point of care.
“Acute infections are among the most frequent diagnoses in outpatient care settings, but they are challenging to diagnose, and current testing methods are inaccurate or too slow. As a result, infections are often blindly – and incorrectly – treated with antibiotics,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “The HostDx Fever test is designed to help physicians quickly diagnose acute bacterial and viral infections in order to improve patient care, reduce healthcare costs and tackle the growing public health problem of antimicrobial resistance. The data we are presenting at IDWeek 2018 show that the genes comprising the HostDx Fever test can be accurately and rapidly measured across multiple rapid laboratory methods, potentially enabling broader access to the test.”
The following abstracts will be presented as posters at the IDWeek 2018 conference:
Title: Taqman multiplex PCR of a seven-gene host biomarker to discriminate bacterial from viral infections (Abstract #72231)
Presenter: Wensheng Nie, Ph.D., Inflammatix
Date/Time: Saturday, October 6, 12:30-1:45 p.m. Pacific Time
Session: Diagnostics: Biomarkers and Novel Approaches
Location: Moscone Convention Center, Hall C, Poster #2016
Title: An ultra-rapid host response assay to discriminate between bacterial and viral infections using quantitative isothermal gene expression analysis (Abstract #72198)
Presenter: David C. Rawling, Ph.D., Inflammatix
Date/Time: Saturday, October 6, 12:30-1:45 p.m. Pacific Time
Session: Diagnostics: Biomarkers and Novel Approaches
Location: Moscone Convention Center, Hall C, Poster #2021
About the HostDx Fever Test
The HostDx Fever test helps determine whether a suspected infection is likely bacterial or viral. The test uses novel, validated technology to measure the expression levels of select host immune genes in blood samples and then applies proprietary algorithms to produce clinically actionable and timely results. The HostDx Fever test’s technology has been validated in 24 cohorts of over 1,000 patients with suspected infection. The test has demonstrated a high sensitivity for bacterial infection (94 percent) and high negative predictive value (97 percent) and its performance was consistent regardless of the infection subtype, clinical setting and time of the year.
About Inflammatix
Inflammatix is a molecular diagnostics company that is developing rapid tests that read the immune system, enabling improved patient care and reducing major public health burdens. The company’s initial focus is on acute bacterial and viral infections, and sepsis, where its HostDx Sepsis and HostDx Fever tests will allow physicians to quickly get the right treatments to the right patients, reducing morbidity and mortality, health system costs, and antibiotic resistance. While current tests diagnose infections by “finding the bug” – an approach that misses the 70 percent of infections that never enter the bloodstream – Inflammatix evaluates the body’s immune system response to provide more accurate and faster diagnosis. Its scientific approach has been validated in over 20 independent cohorts involving over 1,000 patients and published in leading medical journals. The privately held, Burlingame, Calif.-based company is funded by Khosla Ventures, Think.Health, Stanford-StartX Fund and grants from the federal government. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).
Media Contacts
For Inflammatix:
Tracy Morris
[email protected]
650-380-4413
