RE:RE:More consolidation in US health carefrewil11 wrote: Let me guess Change Healthcare was bought out because they are working on early cancer detection through testing of a blood sample , but they won't be launching it to market for another 3 or 4 years , obviously I am just being sarcastic but how is Aristotle completely over looked and no one even knows it exists.
Fair point - when one googles liquid biopsy cancer detection there is really no mention of SZLS. I am posting an overview on this subject I just found on the net - includes Grail.
Approved Liquid Biopsy Technologies
Currently, the CELLSEARCH CTC kit (Menarini Silicon Biosystems, Inc.) is the only liquid biopsy test that has been approved by Health Canada (March 9, 2010).28 It is also the only CTC test that has obtained FDA 510(k) clearance for aiding in the monitoring of patients with metastatic breast, colorectal, or prostate cancer. In addition to its clearance in the US and approval in China, CELLSEARCH fulfills the requirements for CE marking in the European Union.29
It is important to note that liquid biopsy technology is in its early stages of development. The full utility of this technology for screening has yet to be realized. Currently, many of these devices are to be used as a supplement to traditional diagnostic procedures or as a companion diagnostic to guide therapeutic decision-making. Increased sensitivity is required when attempting to detect cancer in earlier stages because of low levels of circulating genetic or cellular material. Therefore, liquid biopsy technology used for the purposes of screening is relatively unrefined. Several liquid biopsies have received a breakthrough device designation (designed to provide patients with life-threating diseases and timely access to medical devices by speeding up the development, assessment, and review process)30 from the FDA. An overview of the timelines for these liquid biopsies receiving FDA approval or breakthrough device designations is shown in .
Timeline of FDA Approvals and Breakthrough Device Designations
Liquid Biopsies for Guiding Therapeutic Decision-Making or Companion Diagnostics
- The cobas EGFR Mutation Test v2 (Hoffman-La Roche Ltd.) was approved by the FDA on June 1, 2016 as a companion diagnostic test with Tarceva (erlotinib) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC).31 The test received further approval as a companion diagnostic test with IRESSA (gefitinib) for the first-line treatment of patients with NSCLC on August 23, 2018.32 The CobasEGFR Mutation Test v2 is used to guide therapy decisions in patients with NSCLC by employing a real-time PCR test to identify mutations for the epidermal growth factor receptor (EGFR) gene. This technology is approved as a companion diagnostic to guide therapeutic options by identifying patients who are candidates for targeted therapies.33
- Guardant360 (Guardant Health, Inc.), a liquid biopsy to inform treatment decisions for advanced cancer patients, received an expedited access pathway designation for breakthrough devices from the FDA on February 15, 2018.34 While not used for screening, Guardant360 can be used to overcome challenges of traditional tissue biopsies in patients with NSCLC by utilizing liquid biopsies to inform treatment decisions before first-line treatment, as well as at disease progression.35 In a study of patients with metastatic NSCLC, Guardant360 and tissue testing detected two times as many patients with targetable alterations versus tissue testing alone (82 patients versus 47 patients, respectively).36 Guardant Health is also developing the LUNAR assay, which includes Lunar-1 for residual disease and recurrence detection, and LUNAR-2 for the early detection of cancer. The LUNAR assay is currently only available for research use.37
- FoundationOne Liquid (Foundation Medicine) was granted breakthrough device designation on April 28, 2018 as a new second-generation liquid biopsy test for patients with solid tumours. The company aims the test to be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.38 FoundationOne Liquid is a next-generation liquid biopsy (blood test) that uses ctDNA to assess solid tumours, and which can be used either as a complement to traditional tissue biopsy results or when a tissue biopsy is not ideal. The results of this liquid biopsy can be used to guide therapy selection among patients with advanced-stage cancers.38
- Resolution HRD (Resolution Bioscience) received FDA breakthrough device designation on May 30, 2019. The company plans to seek approval for the Resolution HRD assay as a companion diagnostic test in solid tumour cancers.39 The Resolution HRD liquid biopsy assay is an in vitro diagnostic test used to detect sequent variation in genes related to homologous recombination deficiency.39 The Resolution Bioscience ctDx platform has been validated to detect single nucleotide variants, indels, fusions, and copy number variation.40 The company’s liquid biopsy assays include ctDx-Lung for identifying targetable mutations for patients with NSCLC and the anaplastic lymphoma kinase (ALK) assay to identify ALK fusions and resistance.41
Liquid Biopsies for Screening or Early Cancer Detection
- Epi proColon (Epigenomics AG) is the first and only blood test screening for colon cancer in average-risk patients older than 50 years. It received FDA approval on April 13, 2016. The test is also available in Europe, China, and selected other countries.21,42 Epi proColon 2.0 CE is a blood test that can be used as an alternative to conventional screening methods to allow for the early diagnosis of colorectal cancer. This test is based on a qualitative assay that detects methylated Septin9 DNA; in patients with positive results, these findings can be verified by colonoscopy or sigmoidoscopy.43 In case-control studies, this technology was shown to discriminate between patients with colorectal cancer and healthy controls with high clinical sensitivity and specificity.43 This test has been approved for people aged 50 or older with average risk for colorectal cancer, and provides another option for people who have a history of not completing screening (by flexible sigmoidoscopy, colonoscopy, or stool tests).44 As noted by the company, this type of screening test may be more acceptable to patients and may increase screening participation among the eligible patients who currently do not participate in screening; currently in the European Union, one in seven patients undergo screening, despite counselling with a health care provider.44
- CancerSEEK (Thrive Earlier Detection Corp.) received FDA breakthrough device designation on August 8, 2018 for the detection of mutations and proteins associated with pancreatic and ovarian cancer.10 CancerSEEK is a blood test that uses ctDNA and protein biomarkers to screen for eight types of cancer — five of which have no screening test (including ovarian, liver, stomach, pancreatic, and esophageal cancer).45 CancerSEEK was tested in a study of 1,005 patients with diagnosed non-metastatic (stage I to III) cancer of the ovary, liver, stomach, pancreas, esophagus, colorectum, lung, or breast; these tests were positive in a median of 70% of the eight cancer types.46 Although this technology is not ready for clinical uptake yet, larger studies of the test are currently being completed.
- ArcherDX's companion diagnostic assay for both liquid biopsy and tissue specimens was granted breakthrough device designation on January 8, 2019 to inform treatment selection of patients with advanced NSCLC.47 ArcherDX has a number of assays, including the Archer Solid Tumor assay for analyzing solid cancer tumours. This includes the Archer REVEAL ctDNA 28 kit, which can be used to analyze plasma to identify cfDNA from 28 common gene mutations.16
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GRAIL multi-cancer early detection test (GRAIL, Inc.) was granted FDA breakthrough designation on May 13, 2019.
48 GRAIL is aiming to develop blood tests that can be used for the early detection of cancer. Its clinical research program includes three studies:
- the Circulating Cell-free Genome Atlas (CCGA) Study, which enrolled individuals with and without cancer in order to characterize the landscape of genomic cancer signals in the blood49,50
- the STRIVE Study, which enrolled a convenience sample of approximately 100,000 women in order to validate a blood test for the early detection of cancer51,52
- and the SUMMIT Study, which will enrol approximately 50,000 participants aged 50 to 77 without cancer — half of whom who will have a high risk of lung and other cancers due to smoking history, and half without a high risk of lung or other cancers based on smoking history. This study is intended to evaluate a blood test for the detection of multiple cancers, including lung cancer.53,54