AusDiagnostics, an Australian startup, said CE-IVD marking has been granted to its assay for hemochromatosis. The polymerase chain reaction test detects mutant and wild-type alleles of the protein hFE.
Researchers recruited 525 patients with diabetes and found that fasting-evoked en route hypoglycemia events were more likely to happen among those who fasted before a blood cholesterol test and could lead to life-threatening accidents. The findings in the International Journal of Endocrinology revealed that "FEEHD is overlooked in clinical practice, and we aim to bring this problem to light and further educate doctors and patients about the consequences of fasting while on diabetes medications," said study author Saleh Aldasouqi.
Brii Biosciences has partnered with VBI Vaccines in a development deal for VBI-2601, an injectable drug designed to strengthen immune responses to hepatitis B virus. VBI will be paid $11 million upfront plus potential milestone payments worth up to $117.5 million and royalties from sales in China, Macau, Hong Kong and Taiwan, while Brii will conduct proof-of-concept clinical studies in China.
Draft guidance is available from the FDA that aims to facilitate approval of cancer companion diagnostics for a class of drugs. The guidance may streamline treatment options for groups of targeted drugs such as PD-1/PD-L1 inhibitors and could boost development of companion diagnostics.
A study in the Blood Cancer Journal found three genetic alterations are associated with a two to three times higher risk of developing multiple myeloma for African-Americans. The findings were based on an analysis of data from samples from 881 people in the Mayo Clinic Genomics Laboratory.
Researchers demonstrated improved engraftment in adults receiving umbilical cord blood-derived stem cells using nicotinamide-based ex vivo expansion technology. They achieved a 94% rate of graft success after six weeks for adults with blood cancer, according to a Phase I/II study in the Journal of Clinical Oncology. "Although umbilical cord blood transplantation has been used for 30 years, expansion technology represents an opportunity to improve the results for adult patients," lead author Dr. Mitchell Horwitz of Duke University said.
Amgen, the Fred Hutchinson Cancer Research Center and Poseida Therapeutics presented oral abstracts at the American Society of Hematology annual meeting on bispecific antibody and anti-B-cell maturation antigen candidates.
Researchers reported in the journal Blood Advances that therapeutic phlebotomy and hydroxyurea are underutilized as treatments for elderly patients with polycythemia vera, despite being linked with reduced risk for thrombosis and improved overall survival. The retrospective study was based on data for 820 patients with a median age of 77 in the Surveillance, Epidemiology, and End Results-Medicare database.
Roche Holding has launched the FoundationOne CDx test, a companion diagnostic for personalized cancer care from Foundation Medicine, in Singapore. The test features an updated gene list compared with its predecessor and is FDA-approved in the US.
Biocartis and Genomic Health are expanding their partnership on breast health to include urology. The collaboration aims to develop an in vitro diagnostic version of Genomic Health's Oncotype DX Genomic Prostate Score test for Biocartis' Idylla platform.