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The accreditation covers postmortem and human performance toxicology analysis, including driving under the influence of drugs and alcohol testing.
CMS revoked the Medicare billing privileges of Alere's diabetes unit, Arriva Medical, claiming it had submitted claims for deceased patients.
CLIA waivers are driving the promise of MDx uptake in physicians’ offices, but achieving adoption in larger settings will remain a strategic imperative.
The firm expects that the CE-marked i-STAT Alinity will eventually replace the existing i-STAT instrument, which is in one of every three hospitals.
Alere said its would-be acquirer has no grounds for seeking termination, but Abbott cited adverse material events as a basis for ending the deal.
The CDC noted that if the test yields a negative RNA NAT result, clinicians should then analyze patient serum using an IgM antibody test.
The ratings agency also assigned a Negative Rating Watch to the firm's notes offering, noting it will resolve this notation as more details of the offering become available.
Abbott said that a lawsuit it filed Thursday tries to obtain important information from Alere before its acquisition is completed.
Synlab, a European lab services provider, found the test performed well on samples with low bacterial load and non-respiratory samples.
Shareholder approval follows China's avowal that it will not block the deal and Abbott's CEO confirming his faith in Alere's business.