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Companion Diagnostics: Page 11
Myriad's myChoice PARP companion test clears FDA
By
LabPulse.com staff writers
PARP inhibitors have become well-established in various lines of treatment for ovarian cancer. The latest approval for Zejula covers use in patients with advanced ovarian cancer after three or more prior chemotherapy regimens and who also test positive for homologous recombination deficiency (HRD). HRD is defined in one of two ways: by genomic instability with disease progression more than six months after a response to platinum-based chemotherapy treatment, or by a BRCA mutation that is deleterious or suspected to be deleterious. Zejula is the only PARP inhibitor with this particular indication in late-line ovarian cancer.
October 23, 2019
Qiagen tie-up with Illumina is a sign of the IVD times
By
LabPulse.com staff writers
Per the deal, announced on October 7, Qiagen gets nonexclusive rights to develop and commercialize IVD kits with Illumina's MiSeqDx and NextSeq 550Dx systems. Qiagen may also expand the agreement to include new diagnostic systems developed by Illumina. Furthermore, the partnership may involve the development of companion diagnostics for Illumina's TruSight Oncology genomic profiling assays for immunotherapy.
October 7, 2019
Agilent gets green light in China for PD-L1 companion test
By
LabPulse.com staff writers
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
Cepheid's leukemia diagnostic receives 510(k) clearance
By
LabPulse.com staff writers
The test delivers accurate molecular results from whole blood samples in less than three hours, according to the company.
October 1, 2019
CAP President Dr. Patrick Godbey sees pathology in driver's seat of medicine
By
Emily Hayes
Godbey was inaugurated as president at the meeting, which was held from September 21-25 at the Gaylord Palms Resort and Convention Center in Kissimmee, FL, near Orlando. On opening night, he was welcomed in a Kentucky Derby-themed party.
September 25, 2019
Foundation, Natera join to develop ctDNA assays
By
LabPulse.com staff writers
The ctDNA assays will be used by biopharmaceutical and clinical customers who order FoundationOne CDx, a broad companion diagnostic clinically and analytically validated for solid tumors.
September 23, 2019
Thermo Fisher seals companion test deal with Lilly
By
LabPulse.com staff writers
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
Genotyping spares bleeding with cardiovascular drugs
By
Emily Hayes
The randomized study showed that the P2Y12 inhibitor clopidogrel (Plavix) was as effective as newer drugs in the class -- ticagrelor (Brilinta) or prasugrel (Effient) -- for preventing thrombotic events in patients undergoing PCI with stent implantation, but with significantly less bleeding. In addition to the presentation at the meeting, results were reported by Dr. Jurriën ten Berg, PhD, of St. Antonius Hospital in Nieuwegein, the Netherlands, and colleagues in the New England Journal of Medicine online September 3.
September 4, 2019
AMP spells out how labs should report genetic test results
By
Emily Hayes
The AMP endorsed the use of evidence-based guidelines for pharmacogenomic tests in clinical practice from the international Clinical Pharmacogenetics Implementation Consortium (CPIC). Pharmacogenomic information is already included in the prescribing information of hundreds of drugs approved by the U.S. Food and Drug Administration (FDA), the AMP noted.
September 3, 2019
Myriad to seek further BRACAnalysis CDx FDA approval
By
LabPulse.com staff writers
The move comes after the AstraZeneca/Merck phase III PROfound study showed that men with this type of prostate cancer who test positive for mutations in homologous recombination repair genes benefit from treatment with olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, the company said.
August 7, 2019
AACC: New diagnostics help labs avoid the commodity trap
By
Emily Hayes
If all labs are viewed as being alike, the focus moves to cost and volume of testing, as opposed to recognition of the value of testing, said Robert Christenson, PhD, medical director of core laboratories and point-of-care services at the University of Maryland Medical Center. Christenson distinguished lab medicine as a service rather than a product, or commodity, during a session titled "The Value Proposition: Actionable Strategies for Enhancing the Value of Laboratory Medicine."
August 6, 2019
Liquid biopsy test detects biomarker for immunotherapy
By
LabPulse.com staff writers
A high degree of MSI has been associated with a positive response to immunotherapy in certain advanced cancers, yet few patients undergo testing for this biomarker, co-author Dr. Jeeyun Lee from Samsung Medical Center in Seoul, South Korea, said in a statement.
August 4, 2019
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