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Nanosphere said that the RV+ test detects influenza A and B and respiratory syncytial virus A and B, and further subtypes flu A as H1, H3, or 2009 H1N1.

BD Diagnostics seeks 510(k) approval for HSV 1 and II assays; Celera submits premarket approval application for KIF6 Genotyping Assay; Cepheid launches Xpert Flu as CE IVD Marked test in Europe.

The disclosure comes almost a year after Calando Pharmaceuticals published phase I data demonstrating that its own cancer drug CALAA-01 could knock down its intended target mRNA and protein inside a tumor through an RNA interference mechanism when delivered intravenously into humans.

FAP is an inherited, colorectal cancer syndrome characterized by the growth of colorectal polyps. Though the polyps are initially benign, they become malignant in nearly all cases in the absence of colectomy, according to Marina.

The agency has created a list of recommendations for nucleic acid-based IVD tests for MRSA and SA in order to help test developers avoid problems such as false reports.

Zineh recently answered PGx Reporter's questions about the agency's efforts in pharmacogenomics and personalized medicine.

PGx Reporter's most-read stories in 2010 delved into the complex scientific challenges, business strategies, and legislative issues impacting the field of pharmacogenomics.

Despite a recent publication questioning the clinical validity of the KIF6 gene variant to predict risk of coronary heart disease and statin benefit, Celera has filed a PMA with the FDA and is embarking on a global commercialization strategy for the test.

The BD ProbeTec HSV-1 and HSV-2 Qx Amplified DNA assays are the first fully automated molecular tests for HSV types 1 and 2.

The firm filed for clearance to run the test on Abbott's m2000 molecular diagnostics instrument system.

The test, which was cleared by the FDA in June, can now be offered in New York.

China's State Food and Drug Administration granted approval for its EGFR and BRAF tests for clinical use.

The phase I drug, ALN-VSP02, comprises two siRNAs, one targeting vascular endothelial growth factor and one targeting kinesin spindle protein, both of which the firm said are critical for the growth and survival of cancer cells.

It is the third Prodesse product cleared by FDA since Gen-Probe acquired the firm a little more than a year ago.

The firm also said it plans to expand its molecular diagnostics menu over the next several months.

Until now, the FDA has not publicly stated that it intends to issue two separate guidances on Rx/Dx development: one focusing solely on advancing companion tests, and another document on how to gain regulatory approval for a drug and test simultaneously.

While payors speaking at a recent conference seemed to be of the opinion that personalized medicine lacks the evidentiary support to justify broad coverage, they suggested that CER may be a way to gather the necessary data on whether to reimburse for genomically guided medicines.

The new platform, called Panther, is expected to help Gen-Probe capture market share in the area of molecular testing at mid- and low-volume clinical laboratories, clinics, and physicians' offices as it competes with platforms from companies such as Roche, Qiagen, Cepheid, and Becton Dickinson.

The Focus Diagnostics Simplexa Flu A/B & RSV test is intended to aid in the detection and discrimination of influenza A, influenza B, and respiratory syncytial virus infections.

The Aptima HPV assay is the last of five diagnostic products filed by Gen-Probe with the US Food and Drug Administration this year.


Novavax 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.