New California Law Increases Access to Biomarker Testing for Late-Stage Cancer Patients

SB 535 aims to reduce delays for the genetic testing that's essential for selecting targeted, more effective cancer treatments

CAMBRIDGE, England, Oct. 13, 2021 /PRNewswire/ -- Biofidelity, a pioneer in precision cancer diagnostics, today praised California Governor Gavin Newsom and the California legislature for the October 6th passage of SB 535, a bill that prohibits health care insurers that already cover biomarker testing from requiring prior authorization for patients with advanced stage cancer.

"Every patient deserves to have the very best treatment options," says Barnaby Balmforth, PhD, Chief Executive Officer at Biofidelity. "This bill marks an important step forward in reducing the delays patients face in gaining access to the testing that makes those options available."

The last decade has brought remarkable advances in precision cancer treatment, says Wendy Levin, M.D., Chief Medical Officer at Biofidelity. As researchers discovered that many cancers are caused by specific mutations in genes, pharmaceutical companies developed drugs to directly target those mutations. For non-small cell lung cancer (NSCLC), for example, there are now more than two dozen drugs that directly target specific mutations.

These targeted therapies offer patients an alternative to a harsh regimen of chemotherapy -- often with better results. Five-year survival rates for lung cancer have tripled since targeted therapies became available in 2010.1

In order to select the right drug or drugs for a particular patient, however, doctors must first test for the specific mutations, or biomarkers, in the patient's cancer cells. That's where the current system often fails patients, Dr. Levin explains. The reasons include the high cost of testing—typically about $5,000 per tumor—and the challenges of getting health plans and insurers to pay for it.

"Unfortunately, only about 50% of the patients in the U.S. diagnosed with cancer who are eligible for molecular testing are actually receiving the tests," Dr. Levin says.2 "By eliminating the need for prior authorization, the new California legislation improves the likelihood that doctors will order the tests."

Equally important, prohibiting the requirement for prior authorization also eliminates dangerous treatment delays as doctors and patients wait for approval.

These delays "can literally mean the difference between life and death for many patients," writes AJ Patel, a legal analyst from Orange County, in a Guest Commentary for supporting the California legislation. "The sooner information on the existence of biomarkers is available, the sooner doctors can begin, in some cases, life-saving measures to treat the patient."

Patel's own life was saved by genetic testing and precision medicine, he writes: "I tested positive for a biomarker known as the ROS1 mutation, which meant that my cancer could be treated with a revolutionary targeted pill…. I am now in complete remission."

Additionally, the days or weeks it now takes for doctors and patients to get reimbursement approval for testing takes a huge toll on patients, says Dr. Levin.

"When you've just been presented with a devastating diagnosis, even a week or two is a long time to wait," she says. "All patients deserve the opportunity to receive the best targeted treatment, and California's new legislation takes us one step closer to that goal."

About Biofidelity
Biofidelity is transforming cancer care by revolutionizing access to best-in-class cancer diagnostics. Its breakthrough ASPYRE technology delivers ultra-sensitive, comprehensive biomarker results quickly and affordably, enabling patients and clinicians to make fast, well-informed treatment decisions. Biofidelity's mission is to improve and extend lives by breaking down barriers to early detection, precision diagnosis and routine monitoring for all cancer patients.

Founded in 2019 in Cambridge, UK, Biofidelity is a rapidly growing private company that recently expanded to include both a U.S. headquarters and state-of-the-art clinical cancer diagnostic laboratory located in Research Triangle Park, North Carolina. For more information, visit or connect on LinkedIn.

Contact: Liz Dowling, (415) 388-2794
Dowling & Dennis PR


  1. Arbour KC, Riely GJ. Systemic Therapy for Locally Advanced and Metastatic Non-Small Cell Lung Cancer, A Review. JAMA. 2019; 322(8):764--774
  2. Chawla A, Peeples M, Li N, et al. Real-world utilization of molecular diagnostic testing and matched drug therapies in the treatment of metastatic cancers. J Med Econ. 2018; 21(6), 543-552.

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