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The in vitro diagnostic uses next-generation sequencing to detect clinically actionable genetic variants to guide therapy selection for cancer patients.

By focusing too heavily on family history, the Preventive Services Task Force is missing many opportunities for prevention, patient advocates, industry players, and researchers say.  

In a hospital setting, 1 in 20 patients had cardiac troponin levels above the cut off for diagnosing a heart attack, including patients with no clinical signs of one.

Palmetto's MolDx has agreed to cover Myriad's MyPath Melanoma to help rule out the disease when the biopsy can't be definitively classified by standard clinical and histopathological characteristics.

The company will launch a clinical version of its liquid biopsy assay in the second quarter and plans to launch clinical trials that make the case for reimbursement.

Epigenomics terminated a licensing contract related to Chinese distribution rights for its Septin9 biomarker and Epi proColon colorectal cancer blood test.

The company ran 668,600 tests during the year, a 30 percent increase from its 2017 testing volume.

The VA decided to bring this testing in house to streamline and standardize the process for doctors and gauge markers that are relevant to the veteran population.

The firm said revenues from its precision oncology business increased 98 percent in Q4, driven by higher testing volume and increased revenue per test.

The test will leverage next-generation sequencing to sequence PCR amplicons of the UL54 and UL97 genes in which drug resistance with CMV has been associated.

Singapore-based Lucence Diagnostics will team with Stanford to analyze sequencing and imaging of liver cancer patients to predict therapeutic effectiveness.

The program is supported via a $25 million gift from philanthropist Denny Sanford and matching contributions fundraised by Sanford Health.

The deal will focus on Biocartis' Idylla MSI test, which provides information on a tumor's microsatellite instability status of a tumor from a single FFPE slice.

The company's assay relies on a set of 15 methylation and microRNA markers to determine whether a woman has breast cancer.

The company said that diagnostic testing volumes, product and royalty revenues, and clinical services revenues all fell year over year.

Using BGI's sequencing technology, the firms plan to commercialize Natera's Signatera test in China and to develop reproductive health tests in "select markets."

The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.

Shanghai RAAS will become Grifols' exclusive distributor of plasma-derived products and transfusion diagnostic solutions in China.

The firm's revenues rose to $21.5 million from $14.8 million in 2017, driven by expansion of its biomarker profiling services business and collaborative program.

Though the firm saw lower overall revenue, it increased its fourth quarter and full-year product and services revenue by 12 percent and 16 percent respectively.

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