NEW YORK (360Dx) – A bipartisan bill has been introduced in the House of Representatives that would create tax credits covering half of the clinical testing costs incurred in the development of rapid diagnostics for certain infectious diseases.
The bill, introduced recently by Reps. Erik Paulsen of Minnesota and Mike Thompson of California, would amend the Internal Revenue Tax Code, and would also provide tax credits to cover half of the clinical testing expenses incurred in the development of drugs and therapeutics to treat certain serious or life-threatening infectious diseases.
More specifically, the bill HR 1840, or the Reinvigorating Antibiotic and Diagnostic Innovation Act, takes aim at antibiotic resistance. The legislation "will remove economic barriers to research and development of new antibiotics and rapid diagnostic tests," Paulsen's office said in a statement.
For rapid diagnostics development, the bill defines clinical testing any human clinical testing occurring before it receives premarket approval or 510(k) clearance from the US Food and Drug Administration, if such regulatory action is required.
Diagnostic tests covered by the bill include an in vitro diagnostic "that provides results in less than four hours and that is used to identify or detect the presence, concentration, or characteristics of a serious or life-threatening infection," including those stemming from antibacterial or antifungal-resistant pathogen.