Research & Development
Small Cell Lung Cancer: Page 3
FDA approves Agilent assay for lung cancer
The test, called PD-L1 IHC 28-8 pharmDx, will help physicians identify patients with metastatic NSCLC who qualify for treatment with a dual immunotherapy combination of nivolumab (Opdivo) and ipilimumab (Yervoy), both of which are manufactured by Bristol Myers Squibb.
May 17, 2020
Qiagen, NuProbe partner on next-generation sequencing liquid biopsy
The companies plan to integrate NuProbe's blocker displacement amplification technology with Qiagen's single primer extension technology to analyze DNA mutations with very low variant allele fractions and support noninvasive cancer genomic profiling. They also aim to develop NGS liquid biopsy oncology panels capable of achieving limit-of-detection standards more cost-effectively than other existing technologies.
March 16, 2020
BioMarker Strategies advances immunotherapy test through SBIR grant
The contract runs for two years and covers use of the test for predicting response to treatments given alone or in combination to patients with non-small cell lung cancer (NSCLC). This represents the second phase of immunotherapy response test development for the NCI; in the first phase, BioMarker Strategies established proof of concept. Immunotherapies have revolutionized the treatment of several cancer types, but there is a strong need for better ways of identifying patients who benefit, as the objective response rates for PD-1/PD-L1 inhibitors are low, ranging from 10% to 30%.
January 6, 2020
FDA clears FoundationOne CDx for Piqray in breast cancer
Piqray was approved by the FDA in May for second-line treatment in combination with fulvestrant for postmenopausal women and men with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer.
December 3, 2019
PathAI reports algorithm on par in PD-L1 immunotherapy studies
The analyses were conducted with Bristol-Myers Squibb (BMS) and tested the algorithm retrospectively in samples from trials of BMS' programmed cell death ligand 1 (PD-L1) inhibitor nivolumab (Opdivo).
November 6, 2019
TRACERx data trove helps refine use of blood markers for lung cancer
The multi-institutional Tracking Non-Small Cell Lung Cancer Evolution Through Therapy (TRACERx) translational research program is studying the genetics of 750 lung cancer patients from the time of diagnosis through surgery and either disease relapse or cure. After surgery, the five-year relapse rate in lung cancer ranges from about 20% in patients with stage I disease to 50% at stage III, the investigators noted.
October 8, 2019
Agilent gets green light in China for PD-L1 companion test
The assay is approved for use as a companion diagnostic with the checkpoint inhibitor pembrolizumab (Keytruda, Merck) as a monotherapy. Clearance covers use in patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with expression of the PD-L1 biomarker. Keytruda was just approved for this indication in China, following approval for use in combination with chemotherapy.
October 2, 2019
Thermo Fisher seals companion test deal with Lilly
LOXO-292 is an investigational drug in phase I/II development for cancers with rearranged during transfection (RET) alterations. An estimated 2% of non-small cell lung cancers and 60% of medullary thyroid cancers have RET alterations.
September 8, 2019
Thermo Fisher flags data for tumor mutation test
Tumor mutational burden refers to the number of mutations in cancer cells. It has been emerging as a biomarker for response to checkpoint immunotherapies, including drugs targeting programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1), though its role is still not well understood.
September 5, 2019
OncoCyte set to buy Razor, reveals plans for lung cancer tests
The Razor Genomics molecular prognostic assay is designed to assess risk of recurrence following the resection of early-stage, nonsquamous non-small cell lung cancer. The test received a positive initial coverage decision in August from the U.S. Centers for Medicare and Medicaid Services (CMS), which should pave the way for reimbursement.
September 5, 2019
Molecular signature shows small cell cancers are birds of a feather
The signature was developed through a computational study of 10,000 patient tumor samples in 35 tumor types -- including small cell neuroendocrine cancers (also called small cell cancers) and non-small cell cancers. Genes that strongly contribute to the small cell neuroendocrine signature include chromogranin A (CHGA), insulinoma-associated protein 1 (INSM1), achaete-scute homolog 1 (ASCL1), neuronal differentiation 1 (NEUROD1), seizure protein 6 (SEZ6), internexin neuronal intermediate filament protein alpha (INA), and NK2 homeobox 2 (NKX2-2), the researchers noted.
July 8, 2019
Bio-Techne's prostate cancer test lands FDA breakthrough status
With the test, a urine sample is evaluated using real-time quantitative reverse transcription polymerase chain reaction (PCR) technology. A higher EPI score is associated with a greater risk for high-grade prostate cancer on biopsy. The test was launched in 2017 in the U.S. by Exosome Diagnostics, which was acquired by Bio-Techne in 2018.
June 19, 2019
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