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The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.

The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.

The bipartisan bill is backed by more than 250 organizations, but ACMG remains opposed, arguing that ordering tests is part of the practice of medicine.

Scheduled to go into effect next year, CMS' price transparency regulations could drive down reimbursements but also streamline billing for hospital labs.

A pair of lawyers familiar with the case said that while ACLA might not win the legal battle, its lawsuit could aid efforts to get a legal fix to the law.

The deal provides whole-genome sequencing for patients with rare diseases or cancer and could make sequencing part of the standard of care for NHS England.

The decision means the ruling by an appeals court that Mayo did not infringe on Athena's patent on a method of diagnosing myasthenia gravis will stand.

The legislation is intended to allow states to conduct whole-genome sequencing on children on Medicaid who have a disease with a suspected genetic cause.

While legislation and lawsuits sought to blunt PAMA's impact, labs also employed new technologies and strategies to cope with anticipated price cuts.

New funding may help improve stalled HIV interventions, in part, by spurring on diagnostic testing access and initiatives.

The bill, which will delay reporting of lab payment data required by PAMA, will now be passed on to the President, who is expected to sign it into law.

Palmetto has expanded the local coverage determination for the Guardant360 liquid biopsy assay to be used with the majority of advanced solid tumors.

Efforts to pass a nationwide surprise billing law appear stalled for now, but state laws and proposals for federal legislation still loom large for labs.

These developments indicate that the law, which would delay the reporting of lab payment data required by PAMA, stands a good chance of passing in 2019.

The US DOJ had alleged Boston Heart Diagnostics conspired to pay doctors kickbacks that were disguised as investment returns.

Athena and its supporters have asked the Supreme Court to clarify patent eligibility, but Mayo recently countered that this is a job for legislators.

The study, sponsored by the US Centers for Disease Control and Prevention, focused on men who have sex with men and members of their social networks.

Since the FDA issued its safety communication in 2017, some lab test developers have mitigated the biotin interference of their assays, but others have not.

The nonpartisan federal agency's report suggests ways for Congress, the FDA, FTC, and CMS to expand oversight of the genetic testing market.

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.

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