Cytovale™ Receives Distinguished Abstract Award from AACC for Evaluation of Sepsis Assay

Poster and Abstract Addresses How Its IntelliSep™ Test Meets Unmet Need of Rapid Sepsis Diagnosis

SAN FRANCISCO–(BUSINESS WIRE)–#AACC2020–Cytovale, Inc., a medical technology company dedicated to revolutionizing diagnostics using cell mechanics and machine learning, has received an AACC Academy’s Distinguished Abstract Award for its abstract titled “Rapidly Assessing the Host Immune Response for the Diagnosis of Sepsis, a Prospective Multi-Site Clinical Study in the Emergency Department (ED) Employing the Leukocyte Structural Index (LSI).” The LSI – Cytovale’s IntelliSep test – is an investigational, pathogen-agnostic direct assessment of white blood cell activation, which allows for rapid quantification of host immune response in an acute care setting. It utilizes routine blood draw samples, requiring minimal operator handling, and achieves a blood-to-answer turnaround time of less than 10 minutes.

Addressing an Unmet Need in the Emergency Department

Sepsis is a dysregulated immune response to infection that occurs when an infection overstimulates white blood cells, which can lead to morbidity and mortality. In fact, sepsis is the number one cause of death in hospitals1, the leading cause for hospital readmissions and among the most costly2. Time is also critical, since for every hour that treatment is delayed, the risk of mortality increases by as much as eight percent3. Currently, no rapid diagnostics exist with clinically actionable performance for early sepsis diagnosis in acute care environments, leaving ED clinicians to balance the benefits of early intervention against the risks of unnecessary and resource-intensive interventions.

The abstract from Cytovale presents the diagnostic value of the Cytovale IntelliSep test in a multi-site, prospective cohort of adults presenting to the ED with signs or suspicion of infection. The abstract builds off previous research that demonstrated the performance of Cytovale’s IntelliSep test4. The new research finds the assay achieves clinically actionable diagnostic performance, allowing clinicians to risk-stratify patients with the highest and lowest likelihood of developing sepsis in an ED population. The authors anticipate that the Cytovale IntelliSep test will improve the identification, management and treatment of sepsis, and have indicated that additional multi-site studies are planned.

Distinguished Abstract Criteria

Cytovale’s abstract was one of only 31 selected for scientific excellence by a panel of Academy Fellows out of 733 accepted for the 2020 AACC Annual Scientific Meeting, which is being held virtually December 13-16. Winning abstracts are being recognized with a ribbon during virtual poster sessions and on the meeting website (visible to attendees). They also are honored in the Academy’s Virtual Membership Meeting and Awards Presentations. All abstracts submitted to AACC’s Annual Scientific Meeting are reviewed and graded on a scale of 1-5 by AACC’s Annual Meeting Organizing Committee. Abstracts receiving a grade of 3.5 or above are submitted to the Academy for Distinguished Abstract consideration, whereby each is reviewed and voted on by a group of six AACC fellows. AACC Academy is composed of more than 600 doctoral level clinical biochemists and is dedicated to advancing scholarship in the field of laboratory medicine.

About Cytovale

Cytovale, Inc. is a San Francisco-based medical technology company that develops host response diagnostics to inform appropriate treatment paths, saving valuable time for patients in life-threatening situations, preventing unnecessary treatment and preserving valuable resources for healthcare systems faced with ballooning costs. Founded upon UCLA research and exclusively licensed intellectual property related to mechanical biomarkers of disease at the cellular level, Cytovale’s solutions are driven by advanced microfluidics, machine learning and ultra-high speed imaging to provide actionable results in minutes. The company is developing the IntelliSep test, a 10-minute test to aid in risk stratification for likelihood of sepsis in ED patients. Cytovale is preparing regulatory submissions for the Cytovale system and IntelliSep test; they are not yet commercially available.

1. Liu V et al. Hospital Deaths in Patients With Sepsis From 2 Independent Cohorts. JAMA. 2014;312(1):90-92.

2. Kumar A et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589-1596.

3. Torio C, Moore B. National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2013. HCUP Statistical Brief #204. May 2016. Agency for Healthcare Research and Quality, Rockville, MD

4. Guillou L, in submission.


Diana Soltesz

Pazanga Health Communications