Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer. This conclusion echoes what opponents of the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) have argued will happen should that proposed bill...

Prosecutors Allege Ex-Theranos President ‘Sunny’ Balwani and Elizabeth Holmes Were ‘Partners in Everything, including Their Crimes’

Like Holmes, Balwani faces 12 counts of fraud and conspiracy to commit wire fraud for allegedly misleading investors, patients, and others about blood-testing startup’s technology Clinical laboratory managers and pathologists are buckling up as the next installment of the Theranos story gets underway, this time for the criminal fraud trial of ex-Theranos President and COO Ramesh “Sunny” Balwani. This week, jurors saw text messages between Balwani and his former business partner girlfriend,...

LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Survey respondents can give their opinions about the proposed VALID and VITAL acts Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written. An LDT is a proprietary diagnostic test developed and performed by...

Post-Pandemic Strategies for Labs Include OIG Audit Prep and Repurposed Instruments

Some lab experts advise that clinical laboratories and pathology practices should also plan on delayed payments for COVID-19 testing for uninsured patients Regardless of whether infection rates for SARS-CoV-2 continue to wane or perhaps surge again, business changes are coming for staff at clinical laboratories and anatomic pathology groups. Forward-thinking lab administrators will want to evaluate post-pandemic strategies for labs to stay ahead of potential legal issues and keep their...

Former FDA Commissioner Scott Gottlieb to Headline Artificial Intelligence in Healthcare and Diagnostics Conference

Gottlieb will speak about the state of AI in healthcare at the event May 11-12 Medical technicians in clinical laboratories and pathology groups may worry that artificial intelligence (AI) will eventually put them out of their jobs. However, that’s not likely to be the case, according to former Food and Drug Administration (FDA) Commissioner Scott Gottlieb. He was just announced as a top speaker at the Artificial Intelligence in Healthcare and Diagnostics (AIHD) Conference, which takes place...

EKRA Now Used to Combat Fraudulent COVID-19 Testing, Too

The Department of Justice steps beyond the law’s original focus on opioid-related lab testing fraud An interesting aspect with enforcement of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is the government’s willingness to go after charges tied to fraudulent COVID-19 testing.  The case U.S. vs. Malena Badon Lepetich provides a good example of this approach. A grand jury indicted Lepetich on various healthcare fraud charges last year, including that she allegedly offered to pay...
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