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The NGS-based test, which was approved by the FDA in June, will be now available to the insurers' members, who have non-small cell lung cancer, in four states.

Theassay is designed for the rapid qualitative detection of platelet factor 4-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia.

The two companies plan to secure required initial regulatory approvals in individual African territories before expanding to other areas in the region.

The NIH is aiming to fund projects evaluating the clinical potential of cancer biomarker assays that are already validated for research use.

The firm said that revenues for the third quarter is expected to be $63.1 million, which would be a 4 percent increase from the year-ago figure.

Hema's Rapid 1-2-3 Hema HIV Express test has been registered by the Chilean Ministry of Health and approved for sale in the country.

The investment bank gave LabCorp an Outperform rating and a price target on its stock of $175. It gave Quest a Market Perform rating and an $88 price target.

In a note, Cowen analyst Doug Schenkel said the company has had trouble meeting its targets and suggested it pursue a strategic sale of its nCounter platform.

The firm estimated that its total revenue in the quarter was $25.9 million to $26.9 million with only $16.9 million coming from products and services.

Under a new deal, EKF's BHB assay is now available for use on Ortho's Vitros 4600 chemistry system and the Vitros 5600 integrated system.

The FDA cited Euro Diagnostica for at least five violations stemming from an inspection of its facility in January, as well as inadequate responses to those violations.  

The firm, which said last week it expected to raise $15.9 million, has said it will use the net proceeds for working capital and general corporate purposes.

The firm is now in talks with commercialization and distribution partners to make the test widely available in Europe and other markets that recognize the CE mark. 

Under a new agreement, Centogene will integrate its CentoMD database of phenotype/genotype variants of rare diseases into the Qiagen bioinformatics platform.

The company also disclosed that the previously announced sale of its PersonalizeDx business has been delayed after the buyer failed to complete the transaction.

The test detects and differentiates norovirus genogroups I and II directly from stool without RNA extraction. 

The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month. 

The company raised its previous €130 million offering of senior notes to €155 million. It also increased its term loan syndication to €190 million. 

The company immediately borrowed $255 million to pay part of the $680 million price tag for Alere's MeterPro cardiovascular and toxicology business and its BNP assay business.

UnitedHealthcare sued the labs earlier this year, accusing them of bribing physicians and others, and billing the insurer for services not performed.  

Following the CE-IVD marking, Bruker launched the two products, the multiplex real-time PCR-based Fungiplex Candida assay and the Micronaut-AM test plate.

Quidel's CEO said that the strategic acquisition adds an extensive cardiovascular and toxicology POC offering to the firm's medical diagnostics portfolio.

The test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.

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