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The US Food and Drug Administration has granted 510(K) clearance for AdvanDx's 90-minute Yeast Traffic Light PNA FISH protocol for detecting Candida yeast.

Merck granted LabCorp a non-exclusive license covering a polymorphism associated with a successful response to peginterferon alpha-based therapy.

Gen-Probe said the assay is the only FDA-cleared molecular diagnostic test that can simultaneously detect seasonal A/H1, seasonal A/H3, and 2009 H1N1.

The head of Roche Diagnostics today highlighted the company's PCR-based tests for human papillomavirus and methicillin-resistant Staphylococcus aureus as potential key drivers of expected continued growth in the coming year of the company's diagnostics business.

Asuragen, Life Tech launch BCR/ABL1 Quant test in Europe; Palex Medical to distribute Molecular Detection’s MRSA assay in Spain; Meridian Biosciences gets FDA nod for C. difficile molecular amplification assay.

Abaxis claims that Cepheid's PCR-based blood test for methicillin-resistant Staphylococcus aureus infringes its sample prep patents. In response, Cepheid has filed a counterclaim denying the alleged infringement and asking the court to find that Abaxis' patents are invalid.

Roche's test becomes the second PCR-based MRSA test approved for clinical use in the US, joining Cepheid's Xpert MRSA/SA nasal assay for the GeneXpert PCR platform.

The illumigene C. difficile molecular amplification test is Meridian's first molecular diagnostic product.

The real-time PCR test is used for direct detection of methicilllin-resistant Staphylococcus aureus nasal colonization.

Roche is the latest firm to receive FDA OK for a molecular MRSA test.

"Although the product appears to continue to meet performance claims as outlined in the current product labeling, an ongoing failure investigation has identified the emergence of novel MRSA strain types as one of the causes of false-negative MRSA results."

The new program applies core technologies from across the company to combine one sample-preparation step with one instrument platform for real-time PCR based detection of Mycoplasma, vesivirus 2117, and mouse minute virus.

The firms are working on infectious disease diagnostics using Protagen's UNIarray platform.

The firm has recalled its Xpert MRSA/SA blood culture product because it produces false-negative MRSA results.

Around a dozen H1N1 tests have gained EUA approval since the FDA gave its first EUA last April for CDC's PCR-based test. However, only two of these assays have received 510(k) clearance, which allows them to be used beyond the EUA.

A number of molecular diagnostic tests that were cleared for emergency use during the 2009 H1N1 influenza pandemic will have to seek full FDA clearance now that HHS has declared the emergency over.

Abbott's system can be used to detect a new strain of chlamydia initially detected in 2008.

The antibody profile could potentially be used to improve stratification of patient cohorts in clinical trials or as a point-of-care test to determine whether a patient needs vaccination, Reinhard Hiller, managing director of CPGR, told ProteoMonitor.

Doing so, however, will require the company to secure additional funding, and it is currently evaluating its options, a company official said.

The new funds follow a $3.3 million Series C financing round closed in late 2009. MDI will use the money to further develop its pipeline of qualitative real-time PCR in vitro diagnostic tests for infectious diseases.

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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.