US-based precision diagnostics company Variantyx has secured $36m in funding to advance its technological and commercial footprint.
Investors included multiple Israel-based venture capital companies such as Peregrine Ventures, Pitango HealthTech, and New Era Capital Partners, along with US-based Bosch Ventures.
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Variantyx’s portfolio includes Genomic Unity, whole genome-based tests that can diagnose multiple genetic disorders, including movement disorders such as ataxia, and Fragile X syndrome. The company also offers prenatal genomic tests that analyse amniotic fluid, as well as blood from both parents to provide a genomic analysis of the foetus.
In 2021, Variantyx expanded into oncology testing with its OncoAlly solid tumour analysis, a pan-cancer treatment optimisation test designed to provide US Food and Drug Administration (FDA) approved and investigational therapy recommendations using comprehensive genomic profiling.
“It’s clear that the current shift away from panel and exome-based testing to whole genome testing benefits patients, providers and payers alike,” said Variantyx’s chief director of clinical genomics, Christine Stanley.
Genetic testing is a growing area of research, with more than 500 devices in active development for genetic testing, as per GlobalData. Of these, 279 are in the late stages of development, with GlobalData predicting these to gain approval within the next decade.
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By GlobalDataMultiple companies have recently released genetic solutions. In September 2023, 23andMe received 510(k) clearance from the FDA to include an additional 41 variants of BRCA1 and BRCA2 genes as part of its BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report. The agency also granted the company the first-ever Predetermined Change Control Plan (PCCP), which outlines the protocols and acceptance criteria to validate BRCA1 and BRCA2 variants.
In October 2023, InVitae received de novo marketing authorisation from the FDA for its common hereditary cancer panel. The in vitro diagnostic test analyses 47 genes associated with cancers to identify an individual’s genetic predisposition. It can also help individuals with already-diagnosed cancer by identifying potentially cancer-associated hereditary variants.
In July 2023, Quest Diagnostics launched its first consumer-focused genetic test, Genetic Insights. The test examines 36 genes using a saliva sample and can analyse the potential risk of up to 24 genetically inheritable conditions, including breast and colon cancer, heart and blood disorders and carrier status for cystic fibrosis, sickle cell anaemia, and Tay-Sachs disease.
