Apostle Lab’s key management team members came from the clinical trial team of Sofosbuvir (marketed as Sovaldi, owned by Gilead NASDAQ: GILD), participating in the clinical team of Sofosbuvir as well as its successor Harvoni (Ledipasvir and Sofosbuvir) during 2011 to 2016, supporting the clinical studies, clinical genomic studies, and FDA submissions. After its approval in 2012, Sofosbuvir is the first drug to eradicate HCV infection in human history. Peak revenue was $12 billion in 2012-2013.
Apostle Lab is one of the clinical laboratory system providers and clinical study participants of Fulgent Genetics (NASDAQ: FLGT). During the COVID-19 pandemic, Fulgent has been one of the largest provide of COVID-19 clinical testing in the US. Its peak revenue was $990 million during 2021-2022. Apostle Lab’s system was part of Fulgent’s clinical testing system authorized by the US FDA EUA. Following the FDA EUA authorization, Apostle’s product and service (as an integrated part of Fulgent service) has been applied in over 20 million clinical tests in the US, covering states of California, New York, Texas, Florida, etc.
Apostle Lab’s key management team members came from and was the lead author of the clinical study team that discovered and commercialized the Quest AccuType IL28B test. IL28B encodes human interferon lambda. Its genetic variant is the most significant clinical determinant of anti-HCV treatment. The scientific breakthrough was published in Nature in 2009, and subsequently was authorized to be a clinical test offered by Quest Diagnostics (NYSE: DGX), the largest clinical laboratory in the world. It was also written into the US FDA guidelines for clinical trials on HCV and precision medicine.
Apostle Lab is one of the providers of clinical laboratory facility and equipment for iHealth Labs (中文：九安医疗，股票代码：002432) in the 510K submission stage in the US market. The iHealth COVID-19 antigen test is one of the most widely sold COVID-19 test kits during the COVID-19 pandemic in the US market. Its peak revenue surpasses $35 billion during 2022.
Apostle Lab is one of the clinical laboratory technology providers of Gritstone (NASDAQ: GRTS). In 2022, a clinical study led by Gritstone, participated by Columbia University Medical School, Mayo Clinic, MSKCC, and MD Anderson, was published in Nature Medicine, titled“Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results.” This phase 1 trial evaluated the safety and preliminary efficacy of Gritstone mRNA neoantigen vaccine in advanced metastatic tumor patients, and reported decreased circulating tumor DNA (ctDNA) in patients with prolonged OS.
Apostle Lab is one of the clinical laboratory technology providers for a phase 1 trial led the NIH. In 2022, led by the NIH, participated by MGH, Duke University School of Medicine, etc, a phase 1 clinical trial was published in Nature Medicine, titled “Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial.” This phase 1 trial evaluated the clinical effects of AAV8-VRC07 on HIV patients’ CD4 cell counts and viral load.
