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The changes include recommendations for first line immunotherapy in patients with high PD-L1 expression, and clarification on use of targeted therapies.

ASCO said MammaPrint should be used to inform decisions on withholding chemotherapy for these clinically high risk, HR-positive, HER2-negative breast cancers.

The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments. 

Last week's buys of two oncology labs will allow Quest to provide new cancer diagnostic technologies to communities lacking major cancer research centers, it said.

While trials targeting actionable mutations are showing promise in some cancer cases, experts say such trials likely need to account for tumor heterogeneity.

Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.

Some aspects of testing practice seem clear, while others present significant challenges for clinicians, according to discussions at the recent ASCO meeting.

Through prospective pancreatic ductal adenocarcinoma testing, researchers saw germline mutations in new genes and in cases outside of current germline testing criteria.

The first randomized study to show a PARP inhibitor benefits advanced breast cancer patients is also a sign of the expanding utility of BRCA testing in precision medicine.

Data presented at ASCO showing 76 percent of cancer patients responded to larotrectinib could lead to the availability of the first tissue-agnostic targeted drug.

The IHC test was used in clinical studies that led to Zykadia's approval last week as a first-line option for metastatic NSCLC patients with ALK rearrangements.

Winship's director of the cancer tissue and pathology shared resource said that some labs aren't leveraging molecular technologies due to reimbursement issues. 

The expanded indication makes it a first-line option for metastatic non-small cell lung cancer patients with ALK rearrangements.

In a milestone for the cancer community, the agency approved Keytruda for the genomic features of a cancer, not where the tumor occurs in the body.

The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi. 

Researchers said that laboratories participating in BRAF proficiency testing include most of the required reporting elements "to unambiguously convey molecular results." 

At the AACR annual meeting, researchers presented results from the Phase II SUMMIT trial investigating the pan-HER-targeted therapy neratinib.

Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.

The study showed that targeted sequencing was feasible, identified many clinically relevant alterations, and directed effective targeted therapy in several cases.

The Medicare contractor is proposing to not cover Vectra DA, but to extend coverage for Prolaris, Xpresys, and DecisionDx-UM under specific circumstances.

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