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MolecularMD

Researchers are using Bio-Rad's droplet digital PCR technology to validate seven ctDNA biomarkers that may predict melanoma recurrence.

The two companies have established a broad framework that will enable them to collaborate on specific projects to develop NGS-based companion diagnostics.

The companies will combine MolecularMD's specialty diagnostic assays with Definiens' quantitative tissue read-outs to provide customized diagnostic solutions in oncology.

MolecularMD's assay will be used to select patients for a Phase II clinical trial in Europe to test an unspecified oncology therapy from Daiichi Sankyo.

The firm's NGS-based Notch 1 mutation detection test will be used to enroll patients in clinical trials.

The NGS laboratory has validated methods and platforms for circulating tumor DNA analysis.

NEW YORK (GenomeWeb News) – Molecular diagnostics company MolecularMD has received CLIA certification for its next-generation sequencing laboratory in Cambridge, Mass.

This article has been updated with additional details about the ClonoSIGHT test and to clarify that Sequenta is in discussions with the FDA to transition the diagnostic from a lab test to a kit.

NEW YORK (GenomeWeb News) – MolecularMD said today it is working with drug firm Novartis to develop a companion diagnostic that can help determine which Philadelphia chromosome-positive chronic myeloid leukemia patients have achieved durable minimal residual disease after treatment with Tasigna (

This article has been updated with a statement from the FDA and to clarify that MolecularMD withdrew its PMA for the T315I companion test after the FDA deemed it not necessary to support Iclusig's administration. Originally published Nov. 1.

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In Science this week: metagenomic-based technique for determining protein structure, and more.

An academic laments the rise of narcissism in the sciences, the Guardian reports.

Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.

The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.