Hologic Gastrointestinal (GI) Testing

    Flexible testing with sensitive GI pathogen detection — diagnostic insights faster.

    collage of lab technicians in a lab collage of lab technicians in a lab

    More Than Gut Instinct

    Reducing the incidence of enteric diseases is a public health priority yet acute gastroenteritis (AGE) remains one of the most common infectious diseases that clinicians face in daily practice.1,2 Up to 3 million people seek medical care for acute gastroenteritis (AGE) each year.3 AGE infections share common symptoms, making it difficult to determine what pathogen is causing the disease. Rapid and accurate diagnostic testing is essential to identify the infectious agent to guide the right treatment for patients and support antimicrobial stewardship.4,6 Trust more than just gut instinct with Panther Fusion® GI Assays and deliver accurate diagnostic insights that can help enhance patient care, support stewardship programs and streamline laboratory workflow.

    Panther Fusion Cartridge Close Up

    Not All Infectious GI Tests Are Created Equal

    Laboratories are increasingly pressed from both sides: deliver more results, faster, while contending with shrinking resources, labor shortages and complex reimbursement landscapes.⁵ 

    When testing infectious Gastroenteritis, labs face a difficult decision: Choosing conventional testing algorithms that are slow, time-consuming, and costly per positive culture, or select Multiplex PCR testing that are rapid and accurate but come with more complexity.11 

    It’s time to reimagine gastrointestinal syndromic testing and trust more than gut instinct.

    179 Million estimated cases of acute gastroenteritis in the U.S. annually.7 

    Up to 83% of deaths associated with AGE occur in people over the age of 65.8 

    Up to 37 million episodes of diarrhea occur annually in children younger than 5 years of age.9 

    Other than Norovirus, Campylobacter, Salmonella and STEC are some of the leading causes of foodborne illness in the United States.10 

    Traditional testing methods are labor-intensive, requiring skilled staff and possibly taking days to return results.11 

    Average TAT of a stool culture 
    54.75 hr12 

    Stool cultures are only positive in 1.5% to 5.6% of cases.13

    A Different Syndromic Approach - The Hologic Solution

    Panther Fusion® GI Assays deliver results that help enhance patient care. With streamlined laboratory workflow, needless complexity can be reduced.

    Energize

    Rapid, flexible testing can help support antimicrobial stewardship programs.4

    Optimize

    Full automation delivers walk-away time, decreasing the strain on laboratory resources.

    Maximize

    Aligning GI panel testing with clinical indications can help reduce the waste of over-testing while navigating a complex reimbursement landscape.

    Panther Fusion GI Assays

    Panther Fusion® GI Bacterial Assay

    The Panther Fusion GI Bacterial Assay multiplex real-time PCR delivers rapid detection and can aid in the differential diagnosis of the most common bacterial causes of acute diarrhea.

    The Panther Fusion® GI Bacterial Assay

    Panther Fusion® GI Expanded Bacterial Assay

    Add more firepower to your GI diagnostic pathway by expanding your diagnostic insight beyond the most common bacterial causes of acute diarrhea. The Panther Fusion GI Expanded Bacterial Assay increases your menu of detectable pathogens, making the implementation of a GI diagnostic stewardship approach simpler.

    Panther Fusion GI Expanded Bacterial Assay

    Need Support?

    All Other Requests

    Innovation never rests, and neither do we.

    Our GI portfolio is under development to bring the diagnostic power of Hologic to a wide range of gastrointestinal illnesses.

    Panther Fusion® GI Viral Assay*

    • Norovirus
    • Adenovirus
    • Rotavirus
    • Sapovirus/Astrovirus

    Panther Fusion® GI Parasite Assay*

    • Giardia lamblia
    • Cryptosporidium spp.
    • Entamoeba histolytica
    • Cyclospora cayetanensis

    Panther Fusion® GI C. difficile Assay*

    • Toxigenic C. difficile
    • Toxigenic hypervirulent C. difficile PCR ribotype 027 (NAP1/B1/027)

    * In development and not for sale

    Unleash the power of the Panther Fusion® System

    • Unleash the Power of the Panther® System. High-throughput, random-access workflows give your lab both the capability and flexibility to deliver.
    • Random & Continuous Access. No more batching; load samples with different test orders as they arrive. Run multiple assays simultaneously.
    • Rapid Turnaround Time and Flexible Testing. Automation speeds up processing and allows you to prioritize tasks without delay.
    • Simple pre-analytical processing. A single sample can be tested with any combination of Panther Fusion GI Assays — no additional hands-on steps required.
      1. Reported incidence of infections caused by pathogens transmitted commonly through food: impact of increased use of culture-independent diagnostic tests — foodborne diseases active surveillance network, 1996–2023. Centers for Disease Control and Prevention. July 4, 2024. Accessed October 30, 2025. https://www.cdc.gov/mmwr/volumes/73/wr/mm7326a1.htm 
      2. Fleckenstein JM, Matthew Kuhlmann F, Sheikh A. Acute Bacterial Gastroenteritis. Gastroenterol Clin North Am. 2021 Jun;50(2):283-304. doi: 10.1016/j.gtc.2021.02.002. Reported incidence of infections caused by pathogens transmitted commonly through food: impact of increased use of culture-independent diagnostic tests — foodborne diseases active surveillance network, 1996–2023. Centers for Disease Control and Prevention. July 4, 2024. Accessed October 30, 2025. https://www.cdc.gov/mmwr/volumes/73/wr/mm7326a1.htm 
      3. Schmidt MA, Groom HC, Rawlings AM, et al. Incidence, Etiology, and Healthcare Utilization for Acute Gastroenteritis in the Community, United States. Emerging Infectious Diseases. 2022;28(11):2234-2242. doi:10.3201/eid2811.220247 
      4. Dumkow LE, Worden LJ, Rao SN. Syndromic diagnostic testing: a new way to approach patient care in the treatment of infectious diseases. J Antimicrob Chemother. 2021 Sep 23;76(Suppl 3):iii4-iii11. doi: 10.1093/jac/dkab245 
      5. Addressing the clinical laboratory workforce shortage. American Society for Clinical Laboratory Science. August 2, 2018. Accessed July 24, 2025. https://ascls.org/addressing-the-clinical-laboratory-workforce-shortage
      6. Shane AL, Mody RK, Crump JA, et al. IDSA 2017 clinical practice guidelines for the diagnosis and management of infectious diarrhea. Clin Infect Dis. 2017;65(12):e45-e80. doi: 10.1093/cid/cix669 
      7. Wikswo ME, Hall AJ. Outbreaks of acute gastroenteritis transmitted by person-to-person contact — United States, 2009–2010. MMWR Surveill Summ. 2012;61(SS09);1-12 
      8. Graves NS. Acute gastroenteritis. Prim Care. 2013 Sep;40(3):727-41. doi: 10.1016/j.pop.2013.05.006. Epub 2013 Jul 19. PMID: 23958366; PMCID: PMC7119329 
      9. Garza JM, Cohen MB. Infectious diarrhea. In: Wyllie R, Hyams JS, Kay M, eds. Pediatric Gastrointestinal and Liver Disease. 6th ed. Elsevier; 2021:291-308 
      10. Centers for Disease Control and Prevention (CDC). Estimates: Burden of Foodborne Illness in the United States. Retrieved from https://www.cdc.gov/food-safety/php/data-research/foodborne-illness-burden/index.html, accessed October 30, 2025 
      11. Zhang H, Morrison S, Tang YW. Multiplex polymerase chain reaction tests for detection of pathogens associated with gastroenteritis. Clin Lab Med. 2015 Jun;35(2):461-86. doi: 10.1016/j.cll.2015.02.006. Epub 2015 Apr 4. PMID: 26004652; PMCID: PMC5002946. 
      12. Beal SG, Tremblay EE, Toffel S, Velez L, Rand KH. A Gastrointestinal PCR Panel Improves Clinical Management and Lowers Health Care Costs. J Clin Microbiol. 2017 Dec 26;56(1):e01457-17. doi: 10.1128/JCM.01457-17
      13. Hatchette TF, Farina D. Infectious diarrhea: when to test and when to treat. CMAJ. 2011 Feb 22;183(3):339-44. doi: 10.1503/cmaj.091495