Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The spread of POC testing technology along with changes in state regulations and pharmacist education are driving an increase in pharmacist-administered testing.
As the circle of doctors ordering drug testing expands, labs find themselves more involved in advisory and interpretive roles that go beyond running assays.
The agency addressed industry stakeholder's concerns about its proposed diagnostic regulatory framework at the American Clinical Laboratory Association's annual meeting.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
While a number of hospitals have sold their outreach operations in recent years, observers suggest these businesses are well-suited to the current environment.
At issue are updates to CMS' guidance instructing labs to report single HCPCS/CPT codes even in cases where a procedure produces multiple reportable results.
BeaconLBS' platform provides physicians with access to evidence-based guidelines and pricing information that can help guide test and lab facility selection.
Regional Medical Laboratory, a commercial reference lab, is using the Alinity next-gen immunoassay system in the face of growing test volumes and a shortage of trained labor.
In a pilot covering 100,000 health providers in Texas, an alliance of healthcare firms found blockchain technology helped maintain up-to-date provider data.
The company said it will use the proceeds to repay outstanding debts including $300 million in senior notes due April 2019 and for general corporate purposes.
Since moving to rapid molecular testing, the lab has doubled its billable test volume, largely through increasing clients for its outreach lab services.
Industry organizations like ACLA are seeking changes to the bill, which appears to outlaw standard business practices such as paying sales staff on commission.
The hospitals expect the Clinical Laboratory of New York facility will translate boosts in test volumes and automation into better economic and health outcomes.
The company's revenues in the quarter rose to $221.9 million from $161.0 million in Q4 2017, but it missed the consensus Wall Street estimate of $245.3 million.
Under the agreement Quest with provide the South Carolina-based medical system with lab management expertise, equipment, testing, supplies, and procurement services.
Members of the FDA, CDC, and CMS, comprising the Tri-Agency Task Force for Emergency Diagnostics, will work together to quickly respond to public health needs.
