Medicare contractor Novitas has been considering a limited local coverage determination for the test, which calculates PSA values and determines whether a patient may need a prostate biopsy.
The study reflects the importance of including multiple biomarkers for diagnostic and treatment decisions associated with pneumonia, IVD industry experts said.
While the laboratory industry hopes expanded price reporting will mitigate PAMA's impact, many labs, especially on the hospital side, may not be ready.
The company said it plans to move all its immunoassays to a single vendor, representing an opportunity worth between $250 million and $400 million annually.
A federal court last week gave preliminary approval to a class action lawsuit settlement that would have Quest give affected patients up to $325 each.
CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.
Clinical services revenues rose 56 percent to $92.6 million while pharma services grew 26 percent to $12.1 million.
Total revenues for the quarter were $2.93 billion, up from $2.83 billion in Q3 2018, and above the consensus Wall Street estimate of $2.91 billion.
Several years into implementation of the ICD-10 system, payors appear to be tightening coding standards, which some labs say has increased denials.
The company will use net proceeds from the offering for R&D, commercialization of its products, working capital, and other business expenses.
Revenues of $1.96 billion for the third quarter were up from $1.89 billion in Q3 last year and beat the consensus Wall Street estimate of $1.94 billion.
LabCorp will operate SBMF's former clinical lab in South Bend, Indiana, and the two parties will collaborate to provide integrated pathology services.
The effort aims to help NJPCA centers improve their value-based care with a focus on patients with chronic conditions like diabetes and chronic kidney disease.
Companies in the AMR space have met resistance from investors and clinicians as a result of conflicting hospital priorities and perceived technology shortcomings.
The immunoblots detect IgM and IgG antibodies to Borrelia species, including B. hermsii, B. miyamotoi, and B. turicatae.
Ortho said that its fully automated technology helps extend antigen phenotyping and ensures delivery of safe blood to transfusion patients.
ACLA filed a motion arguing that HHS' PAMA data collection process is flawed. It follows a July decision that overturned a lower court's dismissal of ACLA's lawsuit.
The agency has proposed rolling back exemptions gained in a 2018 revision of the rule that labs say are key to maintaining access to molecular testing.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.