Research & Development
Policy & Regulation
Trends & Finance
Moderate Complexity Test: Page 2
AMP calls for thorough evaluation of VALID Act
The VALID Act would modify current oversight mechanisms for laboratory-developed testing (LDTs), and groups like AMP are expressing concerns with the current draft. The legislation removes the requirement for approval of LDTs by the U.S. Food and Drug Administration (FDA) in national emergencies. It also gives the FDA the ability to regulate in vitro clinical tests.
April 7, 2022
Article supports FDA review of lab-developed tests
The U.S. Department of Health and Human Services (HHS) in August 2020 ruled that LDTs to diagnose whether patients are infected with SARS-CoV-2 did not have to undergo review by the FDA.
March 7, 2022
FDA grants expanded use of ChromaCode's COVID-19 test
The expanded authorization has the potential to more than quadruple throughput for laboratories, according to the company.
February 24, 2022
CMS will cover free over-the-counter COVID-19 tests
No date has been established, yet CMS said by early spring Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free at local pharmacies and other participating facilities. The policy applies to tests cleared by the U.S. Food and Drug Administration (FDA).
February 2, 2022
PGDx receives updated Medicare rate for Elio test
The Centers for Medicare & Medicaid Services finalized a national reimbursement rate of $2,919.60 for the proprietary laboratory analyses code (0250U) that PGDx obtained for the test, the company reported in a release.
January 27, 2022
FDA warns of shortage of blood sample collection tubes
The FDA said that the U.S. has been "experiencing significant interruptions" in the supply of blood-draw tubes during the COVID-19 public health emergency. The agency in June 2021 issued a letter to labs and healthcare facilities warning of a shortage of sodium citrate blood specimen collection (light blue top) tubes.
January 18, 2022
Nova named president of Veracyte's CLIA U.S. business
Nova will lead all aspects of Veracyte's CLIA business for all diagnostic tests that are performed in the company's laboratories and serve physicians and their patients in the U.S. These aspects include market development, product marketing, payer reimbursement, sales, and operations.
January 6, 2022
Applied BioCode receives EUA for SARS-CoV-2 combo assay
The assay can simultaneously detect and differentiate between SARS-CoV-2, influenza A with subtypes, and respiratory syncytial virus in nasopharyngeal swab specimens, the company said. The test is designed to assist physicians in evaluating patients with clinical signs and symptoms of respiratory infection.
December 16, 2021
FDA tightens policy on reviews of lab-developed tests
In a November 15 press release, the FDA said it was withdrawing its policy that directed the agency to not enforce premarket review requirements for LDTs. The agency said it was taking the action to "help ensure that COVID-19 tests are accurate and reliable."
November 14, 2021
Synaps Dx's Alzheimer's disease test gets payment code
The Discern test is the first autopsy-validated, minimally invasive test for the definitive diagnosis of Alzheimer's disease versus other forms of non-Alzheimer's disease dementias to earn PLA codes 206U and 207U, Synaps Dx said.
November 8, 2021
Reforms needed to clear roadblocks to clinical lab testing
Testing needs during the pandemic are wide ranging and in constant flux, especially with the emergence of multiple strains of SARS-CoV-2. In response, laboratory professionals across the U.S. have been "tirelessly working to provide critical testing during the pandemic but have faced regulatory missteps, staffing strains, and supply-chain shortages," wrote the authors, led by Dr. Eric Konnick.
November 2, 2021
FDA clears Visby Medical's sexual health test
The agency has also granted Visby Medical a waiver under CLIA for the test, the company said. The CLIA waiver allows facilities with CLIA certification to administer the test during a patient's appointment. The test is performed using a self-collected vaginal swab, and results are ready within 30 minutes.
August 29, 2021
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