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regulatory approval

The targeted sequencing assay analyzes 12 genes and can be paired with the firm's BRCA gene testing kit.

Vela Diagnostics said that the RT-PCR-based test has also received provisional authorization from the Health Sciences Authority in Singapore.

The 15-minute test runs on the BD Veritor system, which has a US install based of more than 25,000 instruments.

The company said it will look to obtain regulatory approval in additional countries to accelerate the analyzer's market introduction in Asia and Africa.

The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.

The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.

To enable the use of saliva in addition to other types of samples, Sysmex requested a change to a marketing approval it obtained in March.

The company said that by the end of June it would have made available more than 500,000 kits, which allow individuals to self-collect nasal samples at home.

The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.

The IgG antibody test runs on the Architect i1000SR and i2000SR instruments and will expand to the company's Alinity i system.

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