Inflammatix, a molecular diagnostics company, says that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s TriVerity Acute Infection and Sepsis Test System. 

The TriVerity Test System, which is currently under development, includes the Myrna Instrument and the TriVerity Test and is intended to be used in emergency departments in adult patients with suspected acute infection or suspected sepsis, according to Inflammatix. The TriVerity Test is designed to provide three independent readouts that reflect the likelihood of a bacterial infection, the likelihood of a viral infection, and the risk of severe illness (based on the need for critical organ support* within seven days of presentation to the emergency department).

“We are pleased that the FDA has granted its Breakthrough Device Designation to TriVerity, as it reflects that this novel test system has the potential to help physicians improve on the current standard of care,” says Timothy Sweeney, MD, PhD, CEO and co-founder of Inflammatix. “By reaching this important regulatory milestone, we hope to place TriVerity on an accelerated pathway to FDA clearance, which would allow us to fill an unmet need for rapid, accurate tests for the diagnosis and prognosis of patients with suspected sepsis.”

The FDA established the Breakthrough Devices Program as a voluntary mechanism for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval and marketing authorization.

As a Breakthrough Device, TriVerity is expected to be eligible for the Centers for Medicare & Medicaid Services (CMS) New Technology Add-On Payment (NTAP) program, which will enable future Inflammatix hospital customers to receive a partial subsidy for purchases of TriVerity Acute Infection and Sepsis Tests performed on admitted patients for up to three years. In addition, assuming CMS finalizes its proposed Temporary Coverage for Emerging Technologies (TCET) rule, the TriVerity Test may be eligible for temporary coverage for tests run on discharged Medicare patients for up to four years. CMS is expected to issue its final ruling on TCET in December 2023.

“The potential Medicare reimbursement benefits associated with Breakthrough Designation may expedite implementation of TriVerity in our partner hospitals,” says Sweeney. “We continue to engage with payers, hospitals, and other stakeholders on our path to commercial launch.” 

Further reading: Inflammatix Completes Technical Development of Acute Infection and Sepsis Test System

The TriVerity Acute Infection and Sepsis Test System

The TriVerity Test incorporates a panel of 29 messenger RNAs (mRNAs) to “read” the body’s immune response, providing three readouts to facilitate diagnosis and prognosis of adult patients with suspected acute infection or sepsis that present in U.S. emergency departments. Based on internal analysis of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, Inflammatix estimates roughly 20 million patients per year visit emergency departments with symptoms consistent with suspected acute infection.

The Myrna Instrument is capable of sample-to-answer quantitation of up to 64 mRNAs from whole blood or other sample types in about 30 minutes. While the first version of the Myrna Instrument will require standard laboratory operation, the company’s roadmap includes the development of a Clinical Laboratory Improvement Amendments (CLIA)-waivable version to enable point-of-care deployments.

The company recently announced the completion of technical development for the TriVerity Test System and has resumed its clinical studies, including its SEPSIS-SHIELD study (NCT04094818) required for 510(k) clearance of the TriVerity Test System by the FDA. The multi-center study has already enrolled 955 of the estimated 1,500 patients targeted. The company estimates study completion and FDA submission to occur in 2024.

The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.

Featured image: TriVerity Acute Infection and Sepsis Test System. Photo: Inflammatix

*Defined as the need for mechanical ventilation, vasopressors, or renal replacement therapy.