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Imagine if from a single vial of blood we could detect not just one cancer but potentially hundreds. Blood diagnostics have long been the holy grail for scientists in bio-pharma, a huge advance that has often seemed tantalisingly close but never, quite close enough. But is that finally about to change?
Almost 10 years ago, John Carreyrou broke the story that Elizabeth Holmes was a fraud, that Theranos was a scam and that a lot of important people were going to lose money (including Henry Kissinger $3m and Rupert Murdoch $125m out of pocket). Carreyrou got a Pulitzer, Holmes got a prison sentence, and Netflix made a series.
At least hypothetically, it did a lot of damage to the public image of the blood diagnostics industry. People had become skepitcal of the quantity of bioinformation our blood truly held. These three biotechs, all based near Silicon Valley, watched and continued working. Now, they're saving lives and there's new optimism around a spate of successes and FDA approvals. We explain what they're working on.
Guardant Health
Four years ago last month Guardant Health received FDA approval for Guardant360 CDx. Guardant’s was a landmark moment, the first ever FDA approved blood diagnostic for cancer.
Guardant was widely considered the market darling at the time, but since then their Guardant's stock slumped and has been stymied. Guardant earned the first FDA approval for a breast cancer blood diagnostic in July 2023.
In May this year Guardant got the first FDA approval for a colorectal cancer blood diagnostic. The market responded very well, and Guardant's stock price had doubled 2 months later.
Guardant's so-called Shield test was designed to detect genetic mutations in 55 cancer-related genes. It's seen successful, albeit limited, integration into Medicare and it's eligible for Medicare reimbursement as first-line screening for colorectal.
Guardant says its planning to expand its test to all solid tumour types - that's a bold bet and a huge undertaking, but given their resurgent momentum in this space, it's one worth watching as it plays out.
GRAIL
GRAIL is best-known for its Galleri multi-cancer early detection (MCED) test. The company is at a critical juncture following its June 2024 spinoff from Illumina. Financial pressures have necessitated the concentration of resources on Galleri. Now an independent public entity, GRAIL has had to make strategic decisions to secure its future. Layoffs of 30% to extend cash runway happened next.
GRAIL has narrowed its focus on obtaining FDA approval and Medicare reimbursement for Galleri. As a result of this strategic shift, the company has suspended other projects, including tests for minimal residual disease (MRD) and cancer recurrence monitoring.
GRAIL faces several challenges in its path forward. The company must navigate a complex and lengthy FDA approval process. However, Illumina is a giant of genomics, and it could be that GRAIL is for now just having teething pains, growing into the shoes it has to fill.
Karius
Karius wants to achieve something different - not cancer detection, but infections. They offer a blood test with the aim of improving survival rates for cancer patients who are immunocompromised.
All too often secondary infections sneak into a body weakened by treatment - by chemotherapy, for example. Karius provides a bespoke test to identify infections quickly so they can be effectively treated.
Their so-called Karius test detects microbial DNA from over 1,000 pathogens. The company is focussed on a big research drive, and the results of their most recent trial (PICKUP) were positive.
However, Karius faces several challenges in bringing its innovative technology to widespread use. The company is working on overcoming adoption barriers in hospitals and convincing physicians. They also face the task of justifying the $2,000 upfront cost of their test.
To address these challenges, Karius is collaborating with hospitals that treat immunocompromised patients, collecting research and garnering the support of physicians. If they can make their test more available, more affordable and more widely accepted, they will have a unique upside if they too choose to go public.
