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The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.

CMS gave labs an additional year to gear up for the implementation of the Protecting Access to Medicare Act of 2014 and clarified key programmatic definitions.

Multiple legislative proposals before Congress show regulation of lab-developed tests remains divisive within the life sciences community.

Kapa Biosystems said this week that it has added four new managers as part of the company's expansion, which included moving and in

AdvaMedDx announced this week that it has elected John Bishop, CEO of Cepheid, as the new chair of its board of directors. Before joining Cepheid in 2002, he was CEO and president of Vysis.

This article has been updated with information about a Citizen Petition filed against FDA regulation of LDTs by the American Clinical Laboratory Association, and with quotes from Sherri Bale. Originally published June 4.

AdvaMedDx, a division of the Advanced Medical Technology Association, announced the election of several new members to its board of directors.

Originally published Oct. 1.
A new bill strongly supported within the diagnostics industry could put pressure on the Centers for Medicare & Medicaid Services to alter its procedures for setting reimbursement rates for molecular diagnostics.

Novamax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.

Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.

The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.

This week in Science: Neanderthal Y chromosomes replaced by Homo sapiens Y chromosomes, and more.