NEW YORK – Danaher’s Cytiva announced this week that it has opened a new diagnostics design laboratory in Tonglu, China to allow companies to access its diagnostic services offerings, including laboratory infrastructure, technical expertise, and consultation. The Asia Diagnostics Advanced Application Center has raw material research advice, support to scale up production and manufacturing of lateral flow tests, and provides access to a laboratory for companies that may not have their own lab space. Last year, Cytiva began offering a new diagnostic service to help labs and diagnostic firms accelerate the development of rapid, point-of-care immunoassays.
Guardant Health said this week that the Centers for Medicare and Medicaid Services has granted Advanced Diagnostic Laboratory Test (ADLT) status to its Guardant360 CDx test.
Obtaining ADLT status — which is reserved for FDA-approved tests or other innovative products that provide novel clinical information that cannot be otherwise obtained — initiates a specific, market-based approach to test pricing for the Medicare-covered population. Over the course of nine months, Guardant will collect and submit private-payor payment rate data for its test and CMS will then use the median to determine a new price, which will go into effect on Jan. 1, 2022. In the meantime, Guardant360 CDx will be reimbursed at a rate of $5,000 for Medicare patients.
Invitae this week announced the availability of sponsored genetic testing for patients in the US, Canada, Australia, and Brazil who are suspected of having or who are at risk for common, adult-onset neurodegenerative conditions, such as Parkinson's disease, amyotrophic lateral sclerosis, and early-onset Alzheimer's disease. With this program, Invitae is aiming to increase access to genetic testing for diseases that are hard to diagnose, so patients can benefit from earlier treatment or participation in research.
To qualify for the no-cost genetic testing program, patients must be at least 18 years old, and their doctors should suspect they already have or are at risk for ALS, PD, or AD that manifests in individuals younger than 65 years old, or hereditary prion disease. Eligible patients may be exhibiting clinical symptoms, have a family history of early-onset disease, or know relatives who harbor a disease-causing genetic variant that Invitae tests for. Doctors must order genetic testing for their patients through this program, which includes clinical support, as well as genetic counseling for US and Canadian patients with positive test results. Invitae did not name the sponsors covering test costs within this program but said it may share de-identified patient data with them.
Yourgene Health said this week that its Yourgene Genomic Services COVID-19 testing services have been approved by the UK's Department of Health and Social Care and that the company has been added to the UK government's list of approved providers for testing international travelers for SARS-CoV-2 several days after their arrival. The approval includes both Yourgene's Clarigene SARS-CoV-2 PCR testing service and its genome sequencing testing service that uses ThermoFisher's AmpliSeq SARS-CoV-2 Research Panel.
The College of American Pathologists said this week that it has been reapproved by the Centers for Medicare & Medicaid Services as an accreditation organization for clinical labs. CAP currently accredits about 8,000 labs worldwide. According to CAP, CMS determined that the organization had met or exceeded the applicable CLIA requirements in its application for reapproval. As part of its accreditation process, CAP sends teams to perform on-site inspections every two years.
Cancer Genetics said this week that it has closed its previously announced merger of StemoniX. As part of the transaction, Cancer Genetics was renamed Vyant Bio, effective March 30. StemoniX will operate as a wholly owned subsidiary of the firm. Vyant Bio will be traded on the Nasdaq under the symbol VYNT.
Angle said this week that it has completed fitting out and staffing its clinical service laboratories in Guildford, UK and Plymouth Meeting, Pennsylvania. The labs will enable the UK-based firm to accelerate the deployment of the Parsortix system for use in cancer drug trials. When the labs are accredited and the firm's tests are validated, they will also offer laboratory-developed tests, Angle added. The company plans to seek ISO15189 accreditation in the US, as well as CLIA accreditation. Angle said the first LDT it anticipates making available is the Ovarian Cancer Pelvic Mass Triage assay. In September, the company said it had filed a de novo submission with the US Food and Drug Administration for the Parsortix system for use with metastatic breast cancer patients.
Bluestar Genomics said this week that it has received US Food and Drug Administration Breakthrough Device Designation for its pancreatic cancer liquid biopsy assay in patients with new-onset diabetes. The test uses a patient’s blood sample to identify abnormal epigenomic and genomic signatures linked to pancreatic cancer.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.