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Biodesix

Though the designation has seen slow uptake thus far, three tests received ADLT status in May, bringing the total number of approved ADLTs to five.

Under the agreement, Biodesix will use the Thermo Fisher Ion Torrent Oncomine Pan-Cancer Cell-Free Assay to generate data to apply for FDA premarket approval.

The test measures levels of seven auto-antibodies to tumor-associated antigens, and is designed to detect all forms of lung cancer at any stage.

Under the agreement, MRM Proteomics has granted Biodesix rights to use its iMALDI mass spectrometry technologies to develop blood-based tests for lung cancer.

The year saw the launch of high-profile platforms as well as efforts by a number of parties to streamline mass spec technologies for the clinic.

In data presented at the ESMO annual meeting, the test showed some ability to distinguish between patients who responded to nivolumab and those who did not.

The company is confident about bringing the test to market despite potential future competition and views it as an easy fit for its existing sales channels.

The deal gives Biodesix an additional test in the lung cancer space, Indi's XL2, which helps to classify lung nodules identified by imaging scans as benign or malignant.

The firm also increased the size of its Series G preferred shares offering and will use the funds to develop tests for guiding the use of cancer immunotherapy.

Biodesix will work with university researchers on an assay to help identify non-small cell lung cancer patients likely to respond to certain immunotherapies.

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