The Food and Drug Administration (FDA) introduced a voluntary, 1-year pilot program targeting laboratory developed tests (LDTs) used in cancer treatment selection. FDA says the program will give clinicians guidance and “transparent performance recommendations” for diagnostic tests, helping them identify appropriate cancer treatments.
“The agency has become increasingly concerned that some tests made by laboratories and not authorized by the FDA may not provide accurate and reliable test results or perform as well as FDA authorized tests,” the agency wrote in a news release. Adding that the agency “will continue to work on a broader approach for LDTs, including moving forward with rulemaking.”
During the pilot program, FDA will gather performance information on tests used in clinical trials supporting drug approval from drug manufacturers. Based on this assessment, FDA will release minimum recommended performance characteristics for similar tests used to select patients for treatment with approved drugs.
FDA believes this will help labs develop LDTs that accurately identify biomarkers for treatment selection.
After AACC and other organizations advocated against FDA regulating LDTs as proposed in the VALID Act in 2021, the bill failed to advance in Congress.
AACC remains focused on modernization of CLIA regulations as the best and most effective way to ensure patient access to high-quality laboratory testing, including LDTs.
HEALTH SPENDING TO SWALLOW 20% OF GDP BY 2031
The Centers for Medicare & Medicaid Services (CMS) Office of the Actuary released its projections for National Health Expenditures (NHE) and health insurance enrollment for 2022-2031.
According to the report, the average annual growth in NHE over the next decade will be 5.4%, surpassing the average annual expected growth of 4.6% in gross domestic product (GDP). As a result, the share of health spending as a proportion of GDP would rise from 18.3% in 2021 to 19.6% in 2031.
For Medicare specifically, CMS projects average growth of 7.5% over 2022-2031. In 2022, the combination of fee-for-service beneficiaries using emergent hospital care at lower rates and the reinstatement of payment rate cuts associated with the Medicare Sequester Relief Act of 2022 resulted in slower Medicare spending growth of 4.8%—down from 8.4% in 2021, the report notes.
In 2025, Medicare spending is projected to grow 8.9%, then slow to 6.8% in 2030 and 2031. The anticipated slowdown is due to the Inflation Reduction Act’s provisions on drug price negotiation and inflation rebates, as well as slower enrollment growth as the last of the baby boomer generation, those born between 1946-1964, enroll in 2029.
WINNERS OF $9.2 MILLION ARTIFICIAL KIDNEY PRIZE UNVEILED AT KIDNEYX SUMMIT
The Department of Health and Human Services (HHS) and the American Society of Nephrology announced the eight winners of the Artificial Kidney Prize Phase 2, a competition toward creating a bioartificial kidney. The Kidney Innovation Accelerator (KidneyX) is a collaboration between HHS and the American Society of Nephrology.
The competition divided teams into two tracks, with Track 1 participants each receiving $1,600,000 and Track 2 participants each receiving $1,000,000. The winners were selected for their approaches in developing a fully functional bioartificial kidney, using new methods in xenotransplantation and regenerative medicine.
Designing a bioartificial kidney is very difficult due to the organ's complexity and different cell types, according to HHS. The agency is focused on fostering collaboration among scientists in regenerative medicine, cellular engineering, tissue engineering, systems biology, and synthetic biology.
The technologies awarded include an immunoprotective bioreactor for kidney cell encapsulation, combining kidney organoids and peritoneal dialysis, and a 3D vascularized biomimetic renal construct platform.