Sam Brusco, Associate Editor11.29.23
Inflammatix, a molecular diagnostics company, has won Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) for its lead product, the TriVerity acute infection and sepsis test system.
The FDA’s BDD program seeks to offer timely access to medical devices through speeding up development, assessment, and review for premarket approval and marketing authorization.
"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," Inflammatix co-founder and CEO Dr. Timothy Sweeney told the press. "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 TriVerity test system, currently under development, includes the company’s Myrna instrument and was designed for use in emergency departments in adults with suspected acute infection or suspected sepsis. The test generates three, independent readouts that point to the likelihood of bacterial infection, likelihood of viral infection, and risk of severe illness—based on need for critical organ support (mechanical ventilation, vasopressors, or renal replacement therapy) within seven days of presentation to the emergency department.
Because of the FDA breakthrough designation TriVerity is expected to be eligible for the Centers for Medicare & Mediacaid Services (CMS) New Technology Add-On Payment (NTAP) program for partial subsidy to hospital customers for up to three years. Further—should CMS finalize its Temporary Coverage for Emerging Technologies (TCET) rule, TriVerity could 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," commented Dr. Sweeney. "We continue to engage with payers, hospitals, and other stakeholders on our path to commercial launch."
The FDA’s BDD program seeks to offer timely access to medical devices through speeding up development, assessment, and review for premarket approval and marketing authorization.
"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," Inflammatix co-founder and CEO Dr. Timothy Sweeney told the press. "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 TriVerity test system, currently under development, includes the company’s Myrna instrument and was designed for use in emergency departments in adults with suspected acute infection or suspected sepsis. The test generates three, independent readouts that point to the likelihood of bacterial infection, likelihood of viral infection, and risk of severe illness—based on need for critical organ support (mechanical ventilation, vasopressors, or renal replacement therapy) within seven days of presentation to the emergency department.
Because of the FDA breakthrough designation TriVerity is expected to be eligible for the Centers for Medicare & Mediacaid Services (CMS) New Technology Add-On Payment (NTAP) program for partial subsidy to hospital customers for up to three years. Further—should CMS finalize its Temporary Coverage for Emerging Technologies (TCET) rule, TriVerity could 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," commented Dr. Sweeney. "We continue to engage with payers, hospitals, and other stakeholders on our path to commercial launch."