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After a recent consumer alert from the US Food and Drug Administration, the startup is modifying its sample collection process to only support physician in-person specimen collection.
The San Francisco-based startup believes that its QiSant assay could help guide the use of immunosuppressive drugs and other therapies to prevent kidney transplant rejection.
The firm argues that its tests allows hospitals to expedite patient treatment, while curbing the costs of one-off tests and medication, and minimizing the length of a patient's stay.
Consumers have filed complaints about the San Diego-based firm's questionable business practices and lack of response in the last year.
HTG will leverage existing collaborations with firms including Illumina and Thermo Fisher Scientific to continue building in vitro diagnostic assays on their sequencers.
The company anticipates launching an in vitro diagnostic version of the 10-gene ThyroidPrint assay in South America and Europe after receiving regulatory clearance by Q2 2021.
The firm presented the results of an internal validation study earlier this month at a conference, which applied the amplicon-based tool in hematological cancers.
Formerly called OncoCell MDx, the Royal Oak, Michigan-based firm aims to complete a validation study for the prostate cancer risk assay within the next two months.
The team anticipates launching its first clinical diagnostic assay, which will detect targeted, low-frequency genetic mutations in lung cancer, in 2021.