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More articles about Regulatory News & FDA Approvals

The FDA cleared the firm's microarray-based multiplex platform and a rheumatoid arthritis test that runs on the system.

Studies on genomically defined subpopulations that would advance personalized medicine are "going to get lost in the wash by considering everybody equivalent, which we know they are not," Collins said at a colloquium on personalized medicine hosted by the American Association for the Advancement of Science.

Comparative effectiveness research that analyzes the efficacy and safety of a particular treatment in a genomic subgroup "should address strengths and limitations of this evidence, how specific it is for patient subgroups, and evidence gaps that are priorities for further CER," the report states.

"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins said at a colloquium on personalized medicine hosted by AAAS.

The FDA cleared analytical reactivity information to be added to a package insert for the firm's RAMP Influenza A/B Assay.

The Center for Comparative Effectiveness Research in Cancer Genomics expects its first clinical trial, which is investigating the predictive value of Genomic Health's Oncotype Dx in node-positive breast cancer patients, to serve as a model for future comparative effectiveness studies looking at genomic technologies in cancer.

The newest authorization allows testing on 3M's molecular diagnostic system.

DTC personal genomics firms, such as 23andMe, "don't have a laboratory, but they do [genomic] interpretation," Penny Thompson, deputy director of CMS' Center for Medicaid and State Operations, said during a meeting of the HHS Secretary's Advisory Committee on Genetics, Health, and Society in Washington, DC, last week. "That doesn't fall under CLIA."

Nanosphere received FDA clearance for its influenza and respiratory virus test to run on its new Verigene SP System.

Just because the sponsors performed genomic analyses on samples collected during previously completed trials doesn't mean "they went on a fishing expedition," said FDA's Lawrence Lesko, discussing the agency's re-labeling of Vectibix and Erbitux with gene-response data.

Since the FDA has indicated that most IVDMIAs will have to undergo either 510(k) or premarket approval, the IoM's recommendations will certainly have implications for this subset of devices.

A Roche official said that a primary focus for the company is launching drug/diagnostic combination treatments through its personalized healthcare franchise, since such products are differentiated from others on the market, may go through regulatory approval faster, and justify higher pricing.

Three German labs have accredited the MALDI Biotyper.

"Genetic counselors are not currently recognized by Medicare as providers like most other healthcare professionals are," Elizabeth Kearney, president-elect of NSGC, told Pharmacogenomics Reporter this week. "We want legislation to correct that."

During a webinar hosted this week by Genetic Alliance, Paul Radensky, a partner in the law firm McDermott Will & Emery, discussed FDA's regulation of diagnostic tests and noted that ACLA met with FDA Commissioner Margaret Hamburg to discuss a proposal for an inter-agency approach to regulating LDTs.

In an interview with Pharmacogenomics Reporter this week, Hakan Sakul provided a snapshot of Pfizer's efforts in personalized medicine, the company's stance on regulatory issues, and its overall focus on "omics"-guided medicine.

Pfizer has previously touted PF-02341066 as "the first agent in clinical development that selectively targets a unique genetic feature of cancer cells." The drug is currently in Phase III trials, while Abbott is in the process of designing validating trials for a companion test with the capability to detect ALK gene rearrangements.

In recent years, "I have been involved in product licensing, but I have also increasingly become involved in Rx/Dx partnerships," Cynthia Gawron-Burke, director of external scientific affairs at Merck, said at a conference.

Novartis is developing a companion diagnostic for Prexige and is evaluating its submission strategy for the painkiller with health regulators around the world. Can the Swiss drug giant use pharmacogenomics to resurrect a drug that already bears the stigma of being rejected by the FDA for liver safety concerns?

In order to make the labeling change, the agency reviewed retrospective data from seven clinical trials. But this is the exception, according to one official from a diagnostic company who believes FDA's lengthy deliberations have further nudged drug companies to advance diagnostics at the same time as therapeutics in prospective studies.

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Politico reports that the NYPD DNA database has grown since it announced it would be removing profiles from it.

Forbes reports that a structural biology lab at Oxford University studying the coronavirus was hacked.

Science reports that a Dutch research funding agency is combating a ransomware attack.

In Science this week: set of 64 haplotype assemblies from 32 individuals, and more.