The FDA proposed reclassifying some companion diagnostic nucleic‑acid tests from Class III to Class II, which would allow select tests to follow the 510(k) pathway instead of the more burdensome premarket approval process. Stakeholders say the change could lower development costs for companion diagnostics and broaden participation by smaller diagnostics firms. On Capitol Hill, the House passed the INVEST Act to expand access to capital for small innovative firms by easing certain regulatory barriers. BIO and industry groups praised the bipartisan vote as a boost to early‑stage biotech financing. Together these moves signal policy momentum to reduce friction for both diagnostics and early‑stage biotech funding.