Research & Development
Policy & Regulation
Trends & Finance
Cleveland Diagnostics nabs Medicare coverage for test that interrogates PSA structural variants
In large, prospective multicenter studies of men scheduled for biopsy, IsoPSA demonstrated greater diagnostic accuracy than PSA alone in identifying patients with high-grade cancer
October 13, 2022
Menarini Silicon Biosystems liquid biopsy tests issued CPT-PLA codes
The new CPT PLA codes are Cellsearch Circulating Multiple Myeloma Cell (CMMC) assay - 0337U and Cellsearch HER2 Circulating Tumor Cell (CTC-HER2) assay - 0338U.
October 13, 2022
Helio Genomics obtains CPT code for liver cancer test
When it takes effect on October 1, the new CPT PLA code will provide a reimbursement pathway to enable increased access to HelioLiver, according to the vendors.
July 4, 2022
Immunovia applies to AMA for PLA code
The company has touted the results of a study showing that the test detected stage I/II pancreatic ductal adenocarcinoma with 99% specificity and 89% sensitivity.
April 17, 2022
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
AMA adds new CPT code for COVID-19 antigen tests
The new code -- 87426 -- is intended for use as the industry standard for reporting and tracking of antigen tests using immunofluorescent or immunochromatographic techniques for the detection of biomolecules produced by the SARS-CoV-2 virus, according to the AMA. The code was approved on June 24 during a special meeting of the CPT Editorial Panel.
June 29, 2020
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Quest Diagnostics completes acquisition of Summa Health outreach lab services business
Medicare reimbursement could rev up COVID-19 antibody testing
ACLA President Julie Khani applauded the reimbursement rate, noting that it will allow labs to expand testing capacity. Two Current Procedural Terminology (CPT) codes may be used to bill for tests conducted after April 10 -- 86769 and 86328, CMS explained in a May 19 statement.
May 19, 2020
MycoDart Aspergillus DNA test gets reimbursement code
The Carrollton, TX-based company develops tests for people who need rapid detection of infections, such as patients with cancer or AIDS or those who are undergoing transplants. The accuracy of MycoDart's DNA test is up to 95% and results are available within hours, compared with 50% accuracy and results in days for blood cultures, the company noted in a statement about the CPT code.
August 12, 2019
RenalytixAI kidney disease blood test gets CPT code
The company expects that the new CPT Proprietary Laboratory Analyses (PLA) code -- 0105U -- will help the U.S. rollout of its lead product enabled by artificial intelligence (AI). A Medicare payment rate for the new code will be developed through the 2019 Clinical Laboratory Fee Schedule process, and RenalytixAI expects that this will take effect at the beginning of 2020.
June 30, 2019
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