“Once someone gets through the door to our house, that’s a major achievement,” said Dr Grande. For many patients, going through a complex journey to treatment, involving multiple return visits over a period of weeks or months, can be overwhelming. “It’s just a big hurdle.”
Automated molecular tests could compress this process. Starting with a small sample of blood or saliva, the tests amplify any trace of viral genetic material in a process similar to the old polymerase chain reaction (or PCR) method in the laboratory, but have been miniaturized to work on small machines. The technologies have been around for years but gained prominence during the pandemic, when the FDA allowed many test developers to skip what is traditionally a lengthy approval process.
Companies that have developed coronavirus tests of this ilk have seen tremendous growth. Cue Health, which is the NBA’s official testing provider and has sold more than 120,000 testing rigs, reported that annual revenue increased 25-fold to more than $600 million during the pandemic. Ayub Khattak, the company’s co-founder, said the streamlined regulatory process was transformative: “It just broke the door.”
A similar molecular test for hepatitis C could allow clinicians to make a diagnosis immediately and perhaps begin treating many patients the same day, an approach known as “test and treat.” Patients may then be less likely to transmit the disease to others and more likely to complete treatment and be cured.
One of the most promising tests for hepatitis C has been created by Cepheid, a California-based diagnostics company. With a palm-sized cartridge preloaded with chemical reagents, the test runs on the company’s proprietary GeneXpert machine and can confirm the presence of a suspected pathogen in less than an hour. Due to its simplicity and size (the entire unit is the size of a desktop printer), it can be deployed to remote sites and can be used by staff members with minimal medical training.
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Research on how prompt diagnosis affects treatment of hepatitis C patients is limited. In a pair of pilot studies where the technology was applied to a needle exchange and a prison, more than two-thirds of patients diagnosed started treatment, perhaps double those who started treatment under conditions typical. Both studies received drugmaker funding and in-kind support from Cepheid.
Jason Grebely, one of the researchers leading the study and a professor at the Kirby Institute, a medical research organization in Sydney, Australia, said the technology “is probably the next game changer” in the field of treatment of hepatitis C. Grebely has previously received research funding from Cepheid and various pharmaceutical companies.