NEW YORK (360Dx) – Color this week announced that it will offer $50 confirmatory testing for individuals who have positive results from 23andMe’s direct-to-consumer genetic test that gauges three BRCA1 and BRCA2 mutations.
The BRCA1 185delAG, BRCA1 5382insC, and BRCA2 6174delT mutations gauged by 23andMe’s test occur in around 2 percent of Ashkenazi Jewish women and significantly increase their risk of breast and ovarian cancer. The FDA recently authorized 23andMe’s test for direct-to-consumer sales with a number of caveats about its limitations, and informed people not to make decisions about treatment or prophylactic surgeries based on the DTC test. As GenomeWeb recently reported, this has industry stakeholders wondering whether insurers would cover confirmatory assessment in this context based on FDA’s determination, since typically, insurers only cover testing when patients have a very strong family and personal history of cancer.
“We believe the right thing to do is offer people with suspected mutations from a DTC test access to an affordable physician-ordered clinical test from a CLIA-certified, CAP-accredited lab,” Color cofounder Othman Laraki said in a blog post. For those qualifying for confirmatory testing, Color will perform its 30-gene hereditary cancer panel (including BRCA1/2) and provide genetic counseling for $50. The panel, which is ordered by a third-party network doctor or the patient’s own doctor, usually costs $249.
OncoDNA said that it has signed a collaboration agreement with MD Anderson Cancer Center Madrid, under which oncologists who work at the center will now be able to use OncoDNA's portfolio of genomic analysis tools for their patients.
OncoDNA will also work with the center to carry out genomic studies and conduct research aimed at building more effective and less invasive methods in the fight against cancer, company CEO Jean-Pol Detiffe said in a statement.
The announcement follows a series of other agreements with Spanish hospitals and clinics in recent months, the company said. Financial details were not disclosed.
Thermo Fisher Scientific has opened a US Precision Medicine Science Center in Cambridge, Massachusetts. The center offers collaborators access to omics technologies — such as genomic, proteomic, and metabolomic analysis tools — and expertise to develop analytical workflows for generating molecular profiles of patient samples. Specifically, the center has a team of experts in biochemistry, mass spectrometry, molecular biology, and data science available to help partners develop standard protocols to shorten R&D and quickly move from biomarkers to assay development. Last year, Thermo Fisher opened a similar center in Guangzhou, China.
London-based OME Health has raised $1.25 million in seed funding from a financing round led by Inventure, a Nordic technology fund, with participation from Doehler Group, Practica Capital, and several angel investors in the UK. OME Health plans to use the new funding to expand its commercial activities in the UK and in continental Europe. The firm, which was founded in 2016, offers a personalized 12-week health plan that is based on an individual's gut microbiome, genetics, blood markers, and other health data. It has clients in the nutrition and health insurance industries, and collaborates with global food manufacturers to develop personalized nutrition offerings.
Rostock, Germany-based Centogene will open its first US-based rare disease laboratory in Cambridge, Massachusetts on August 1. The lab will be a point of contact for the company’s collaboration partners leveraging its diagnostic services in the US. The new space will have a state-of-the-art high-throughput genetic testing lab with biochemical, proteomic, metabolomic, and genetic analysis capabilities. Earlier in the year, the company said that it would look to expand into the US, and in December it opened an office in Boston.
Premaitha Health said this week that it has signed a three-year agreement with an unnamed clinical laboratory group in India to provide a bespoke scalable NIPT solution in the Indian market. Premaitha, through its Yourgene subsidiary, will offer mass-population NIPT screening to patients in more than 2,000 cities and towns in India. The bespoke NIPT screening system uses a DNA preparation technology from Premaitha's development center in the UK. The firm will supply sample and library preparation consumables to its partner's central laboratory in India, and will perform the NIPT analysis on the resulting sequenced DNA data in Yourgene's bioinformatics center in Taiwan.
Abbott’s board declared a quarterly dividend of $.28 per share, payable on Aug. 15 to shareholders of record at the close of business on July 13.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.