NEW YORK – Qiagen said this week that its Therascreen BRAF V600E RGQ PCR kit has received US Food and Drug Administration approval as a companion diagnostic to the BRAF inhibitor encorafenib (Pfizer/Array BioPharma's Braftovi). The FDA approved the drug last week for use in combination with cetuximab (Eli Lilly's Erbitux) for BRAF V600E-mutate metastatic colorectal cancer patients, as detected by an FDA-approved test, after prior therapy. The Therascreen kit runs on Qiagen's Rotor-Gene Q MDx instrument. It is the first companion diagnostic test from Qiagen to obtain FDA approval for the detection of a mutation in the BRAF gene and its third CDx approval in colorectal cancer.
Epigenomics said this week it has initiated comprehensive measures to reduce costs in order to preserve its liquidity during the COVID-19 pandemic. The company has reduced expenses across all areas of its business, including payroll in both Germany and the US. An application for short-time work was submitted last week for all employees at Epigenomics' headquarters in Berlin, which is under review for approval by the Federal Employment Agency. Additionally, the company’s executive and supervisory boards are voluntarily waiving a portion of their compensation until further notice.
These measures have been taken as a precautionary action and will apply for the coming months depending on the duration of the pandemic, the company said. Coupled with a financing round completed at the end of March, Epigenomics believes that these precautions have ensured that the company will have sufficient liquidity into Q1 2021.
Aside from these measures, however, Epigenomics said it expects to remain operational, and will continue to fulfill customer orders and be in full compliance with its legal, regulatory, and financial obligations. These measures also have no effect on the National Coverage Determination process currently underway for Epi proColon at the Centers for Medicare and Medicaid Services. The company still anticipates that CMS will issue a proposed NCD by Aug. 28 and a final NCD by Nov. 28.
Centogene and German blockchain start-up Ubirch announced this week that they have jointly developed software to provide readily available and secure access to results of SARS-CoV-2 tests performed at Centogene's laboratories. Test results will be directly sealed virtually on the blockchain using the Ubirch solution, and will be accessible when an individual needs to show proof that they are not infected by the virus in order to gain access to a production plant, public transportation, or a hospital, the companies said. The test results can be verified with a genuine blockchain certificate.
Centogene also noted that it is in discussions with other partners to enable companies to quickly set up a coronavirus tracking infrastructure, in which the results of mass screenings can be used to release people from quarantine or allow them to participate fully in economic and social life.
Genomics Medicine Ireland, the Health Service Executive, and National Virus Reference Laboratory last week inked a deal aimed at increasing the supply of reagents to ramp up testing of individuals suspected of being infected with SARS-CoV-2. Under the terms of the deal, GMI and NVRL have secured reagents for producing up to 900,000 tests and components for the first 200,000 have been delivered to NVRL’s laboratory in Dublin. In the coming weeks, production will be increased to 10,000 tests per day enabling more rapid sample analysis and quicker turnaround times to return results to clinicians, the partners said.
Horizon Discovery said this week that it is instituting special commercial licensing terms to facilitate rapid access to its cGMP-compliant CHOSOURCE platform for the development or production of therapeutic proteins, diagnostic assay components, or vaccines relating to COVID-19. The CHOSOURCE platform includes a gene-edited Glutamine Synthetase knockout Chinese Hamster Ovary (CHO) K1 cell line, a GS expression system suitable for high-yield biomanufacturing. The company already offers the platform as a royalty-free alternative to produce complex proteins.
Todos Medical said this week that the US Food & Drug Administration has accepted its application for Medical Device Establishment Registration, allowing it to import medical devices for commercial sale that have been manufactured by non-US entities. Todos has inked agreements to import fingerprick-blood antibody kits and oral or nasopharyngeal swab, saliva, and stool-based PCR test kits for the coronavirus that causes COVID-19. The company has also signed agreements to import automated extraction laboratory equipment to support risk stratification screening and high-throughput reflex testing.
Vermillion said this week that its wholly owned subsidiary, Aspira Labs, has been credentialed with Florida’s State Medicaid program for an estimated additional 3.6 million Medicaid-covered lives. Aspira is credentialed with Medicaid programs in four of the five largest Medicaid states by population, including California, Pennsylvania, Texas, and Florida. Vermillion said it is in the process of getting credentialed in the largest Medicaid state, New York. Being Medicaid-credential in Florida also allows Aspira to seek participation as a network provider with commercial Medicaid health plans.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.