Close Menu

More articles about Business, Policy & Funding

With the inclusion of ConfirmMDx in the Medi-Cal program, MDxHealth will seek access for the test in other state Medicaid programs.

Danaher said that it expects the acquisition to be accretive to earnings in the fifth full year post acquisition.

The pre-market approval application is based on data collected during a two-year prospective study of more than 33,000 women.

The US Food and Drug Administration has already granted EUA to the test, which detects viral RNA in serum and urine.

The deal, which included $225 million in upfront payments and up to $185 million in milestones, gives Myriad entry into the neuroscience space.

Executives of firms developing and launching various assays believe their diagnostic tests will be among the most important tools in controlling Zika. 

Industry executives said they believe ASRs are key components for laboratory directors who need to quickly develop critical diagnostic tests. 

Alere filed a legal complaint in order to push Abbott to obtain the anti-trust approvals needed to complete the acquisition proposed earlier this year.

The new guidance could benefit Hologic and Roche, both of which market molecular blood screening tests authorized by the FDA under an investigational new drug study protocol.

The firm's approach to sepsis is at the core of its infectious disease testing strategy with MDx, biomarker tests, and mass spec technologies all playing a role.

Last week, the G-BA, a committee that decides about reimbursable medical services in Germany, said it will start a methods evaluation of noninvasive prenatal testing.

The deal is still subject to other closing requirements including meeting a minimum tender condition.   

The point-of-care test delivers results in 13 minutes or less and will be available for the 2016-2017 respiratory season.   

The firm sees the new panel as an important step forward in its strategy to further penetrate the molecular diagnostics market with its qPCR products.

The firm has made a series of acquisitions and entered into strategic collaborations over the past couple of years aimed at rapidly growing its MDx offerings.

Although the financial filing sheds increased light on Alere's business, the company is asking for an extension to file its second quarter financial statements.

As LDT developers await an FDA decision on potential new regulations and grapple with reimbursement issues, investors may be unwilling to deal with the uncertainty.   

The move follows the inclusion of Cologuard in the US Preventive Services Task Force's updated colorectal cancer screening recommendations.

Facing CMS sanctions, lab industry insiders ponder the firm's options in seeking to launch a Zika virus assay with emergency use authorization on its upcoming miniLab platform.

The new coverage decisions follow updated recommendations from the US Preventive Services Task Force on colorectal cancer screening.

Pages