ACLA

At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.

Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.


The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.

These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.

New Medicare rates established under PAMA will cause labs to scale back services, and in some cases shut down, the motion states.

The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.

The suit filed against the acting HHS secretary alleges that a flawed data collection process failed to establish market-based rates.

Smaller labs, hospital outreach labs, and labs servicing high numbers of elderly are thought to face the highest risks.

The government payor proposed rates that would reduce payment by $670 million, though CMS previously estimated a $390 million cut in 2018.

Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.

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Customers might want to consider what they might learn about their risk of diseases like Alzheimer's before snagging the genetic testing kits that are on many gift guides this year, NJ.com writes.

The Wall Street Journal reports there is uncertainty surrounding whether He Jiankui's embryo editing did what he said it did.

Stat News reports that the pause on procuring fetal tissue for intramural US National Institutes of Health research will soon affect additional labs there.

In Nature this week: genomic analysis of the invasive fall webworm, amp of constrained coding regions within the human genome, and more.