AACC

Selected companies developing innovative technologies and products could receive breakthrough device designation and greater access to FDA guidance.

Practice recommendations could serve as a guide for labs considering using the high-sensitivity assays as they become available, authors said.

Laboratory industry associations plan to advocate for continued test harmonization funding in future budgets.

The new Kidney Profile combines two existing tests for chronic kidney disease and could be critical in addressing the under-diagnosis of the ailment.

The guidelines are the first to attempt to specify which drugs are appropriate to test for routinely, guideline authors say.

Qualitative testing offers more specificity and sensitivity than current frontline immunoassay-based testing, the group said in its guidelines.

Project would be managed by the US Centers for Disease Control and Prevention and would require tests from different manufacturers produce the same results.

The AACC called for increased collaboration between physicians and laboratory medicine professionals, as Medicare changes how it reimburses for clinical lab tests.

Theranos CEO Elizabeth Holmes speaks at the AACC 2016 meeting

At the American Association for Clinical Chemistry meeting, Theranos CEO Elizabeth Holmes said her company is working on third-party review and publications of the firm's technologies and tests.

CHICAGO (GenomeWeb) — Seegene this week plans to submit its first molecular diagnostic test for US Food and Drug Administration clearance, an assay for herpes simplex virus I and II that uses the company's TOCE primer technology for multiplexed real-time PCR.