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The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May.
The lab firm was accused of billing government payors for unnecessary testing as well as paying illegal compensation to phlebotomy vendors.
AMA's suggestions include increasing transparency about testing capacity and providing guidance on serology tests, among other things.
The multiplex assay is designed to detect both the SARS-CoV-2 nucleocapsid protein from nasal swabs and patient-derived antibodies against the viral spike protein 1 from blood drops.
The company said it can now market test kits for both liquid biopsy and FFPE samples to labs in the EU and other participating geographies.
BGI will establish six so-called Huo-Yan COVID-19 testing labs in Saudi Arabia, based on the emergency lab the firm set up in Wuhan, China in February.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
The RT-PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in a range of upper and lower respiratory specimens including nasal swabs and sputum.
NeoGenomics noted that test volumes had been disrupted by the COVID-19 pandemic, leading to reduced growth in the company.
The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.
The studies indicate that true infection numbers greatly exceed confirmed case counts, but questions remain about test performance and sampling biases.
The test detects IgG antibodies in human serum and plasma and is intended to identify people with an adaptive immune response to SARS-CoV-2.
Thermo Fisher's line of ImmunoCAP assays are designed to detect immunoglobulin E in order to identify allergic sensitization to a range of allergens.
The tests for detecting IgG and IgM antibodies can be used manually or with any open automated ELISA analyzer, the company said.
Illumina had sought to exclude the Harmony test from the US Market, while Ariosa had sought to overturn the jury verdict with a post-trial maneuver.
All three tests use upper respiratory specimens such as nasal swabs, but the AIT and MicroGenDx tests can also use sputum samples.
The additional funds will be used to advance the development of the company's Next Generation Phenotyping technology through clinical trials.
Leinco said as part of the agreement it will use its protein expression technology platform to rapidly scale up manufacturing of the antibodies.
The company plans to use the proceeds to support a variety of general expenses, including research and development, administration, sales, marketing, and capital expenditures.
Novacyt has initially committed to supply 288,000 tests per week to the DHSC, and it has an option to expand the agreement.
The funds will be used to support the molecular diagnostics company's growth strategy and for general corporate purposes, MDxHealth said.
The immunoassays are designed to detect certain SARS-CoV-2-associated antibodies to help identify individuals with adaptive immune responses to the virus.
The test will run on DiaSorin's Liaison XL immunoassay platform. Five thousand platforms are installed worldwide, including 600 in US labs.
The combined company will have operations in California and Texas, and will provide onsite, rapid diagnostics with data analytics capabilities.
The San Diego-based genome mapping firm's share price fell below $1.00 for 30 consecutive days, triggering a noncompliance notification from Nasdaq.