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More articles about Regulatory News & FDA Approvals

Simplexa, manufactured by Quest's Focus Diagnostics business, is the first test to be cleared by the FDA to aid in detecting and differentiating influenza A and 2008 H1N1 influenza viral RNA.

As a result of the 510(k) clearance, Quest's Simplexa Influenza A H1N1 test will be the only one that can be marketed after June 23 when the public emergency stemming from the virus is lifted.

The firm said that its test is the first cleared by FDA for molecular detection of HSV.

EraGen Biosciences gets 510(k) clearance for PCR-based HSV IVD; Molecular Detection and Launch Diagnostics launch Detect-Ready MRSA assay.

"The fact is that Pathway's bold move to make themselves noticed achieved its end and brought them to our attention," an FDA official told Pharmacogenomics Reporter.

The test, built on the company's VeraCode technology, is for Factor V and Factor II.

China's food and drug regulator has cleared two microarray tests and an amplification test for identifying and differentiating tuberculosis.

FDA believes Pathway Genomics is offering a device that has not been cleared for marketing by the agency, and that the firm has "moved outside of the currently sanctioned boundaries for lab-developed tests by marketing a product in a retail store that asks consumers to collect the sample."

IQuum said that it has developed a nucleic acid-based test that can provide results in just 26 minutes.

NanoString's nCounter gets ISO 13485:2003 certification; FDA clears Osmetech's eSensor thrombophilia risk test; PerkinElmer launches prenatal BACs-on-Beads assays in EU

The Seattle-based firm received ISO certification covering its nCounter multiplex molecular detection instrument and reagents.

The FDA clearance positions the firm to enter the clinical molecular diagnostics market with the BeadXpress system, which was previously marketed for research use only.

The cancer biobanking and services company established a new management system to cover all of its processes.

Although Qiagen is prioritizing Rx/Dx partnerships with pharma, that doesn't mean it won't look into bringing tests to market with payors or on its own.

For Dx shops developing pharmacogenomic tests without big pharma's help, Medco says it can offer a better value proposition when it comes to driving adoption and reimbursement for their tests.

Synlab has started offering Epi proColon, Epigenomics' PCR-based blood test for early detection of colorectal cancer, through 55 German sites in its network. In addition, Epigenomics recently raised €33.1 million ($44.2 million) through a combined private and public share offering.

"Cytogenetics is one of the first areas where there is interest to move beyond the current research studies, which will require an FDA cleared or approved product," said a Roche NimbleGen official.

The 510(k) clearance covers an AdvanDx protocol that speeds up identification of two fungal infections to 90 minutes.

Wafergen said that the agreement would support the commercialization strategy for its SmartChip Real-Time PCR system, due to launch later this year.

The College of American Pathologists has accredited Rosetta's lab, which offers microRNA-based tests.

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The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.