The companies will work together first to develop a companion diagnostic for Bayer's TRK inhibitor larotrectinib, with opportunities to expand to other drugs and drug candidates thereafter.
The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.
Investigators concluded that the spiked samples from SeraCare were a robust tool for inter-lab comparisons and discussed some areas of discordance seen in the study.
The researchers have used nCounter, an FDA-cleared platform from NanoString Technologies, to develop their gene expression assay for subtype classification.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
The partners believe their technology could have advantages over others used in early-stage cancer detection, such as next-generation sequencing.
The FDA said Beckman Coulter notified customers on Monday of an updated urgent medical device recall letter that replaces an initial notification last year.
The firm plans to use the funds raised to support business activities, as it moves forward in the development of cancer early detection tests.
The Australian firm will use the proceeds for R&D, expansion in China, and to fund the development of polygenic risk tests with TGen in the US.
The firm said that it may use some of the net proceeds to acquire or invest in complementary businesses and technologies.
The company will now be able to market the test, which algorithmically weighs molecular markers and clinical information, in all 50 US states.
The company said adopters are ordering tests in areas of great interest, like CTC and blood biomarker monitoring, despite a lack of reimbursement.
MammaPrint classifies patients as either high risk or low risk of recurrence over a 10-year period while BluePrint classifies patients by breast cancer subtype.
The company estimated that the offering could raise between $327.2 and $376.3 million, which it would use for various corporate purposes.
The company, based in Fort Myers, Florida, said that it plans to use the net proceeds from the offering for general corporate purposes.
The decrease came as improved performance by its biopharma services operations was more than offset by declines in clinical and discovery services revenues.
Shares jumped nearly 90 percent today after the firm said this morning that it has commercially launched its Target Selector NGS Lung Panel assay.
The firm has developed a digital platform that determines whether patients meet guidelines for genetic testing, and if so, what test they should receive.
The test will guide clinical decision making related to Inovio's DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus.
PGDx, the defendant in the liquid biopsy IP case, has alleged that Guardant's CEO should have been named as an inventor on patents but was purposefully left off.