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Guardant Health

In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.  

The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.

The company sold nearly twice as many tests as in Q2 last year, with clinical test revenue more than doubling and total revenue reaching $54 million for the quarter.

Guardant told a federal judge that it believes Foundation Medicine and Personal Genome Diagnostics are coordinating to invalidate its patents.

The Patent Trial and Appeal Board has denied Foundation Medicine's request for Inter Partes review.

The broader market drove down the stock prices of many diagnostics companies. Natera, Guardant Health, and CareDx paced the gainers.

The firm plans to use the funds raised to support business activities, as it moves forward in the development of cancer early detection tests.

 

The company estimated that the offering could raise between $327.2 and $376.3 million, which it would use for various corporate purposes.

PGDx, the defendant in the liquid biopsy IP case, has alleged that Guardant's CEO should have been named as an inventor on patents but was purposefully left off.

During its earnings call this week, the liquid biopsy firm said it is planning a 10,000-patient trial to test its Lunar assay for colorectal cancer screening.

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