The tests are designed to detect regions in the SARS-CoV-2 genome in respiratory samples or antibodies against the virus in human serum, plasma, or blood.
Progenity recently agreed to pay millions to three major insurers under settlement agreements related to allegations over undisclosed past business practices.
The firm has granted the underwriters an option to purchase up to 2,400,000 additional shares, which would contribute additional gross proceeds of up to $38.4 million.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The warning letters may signal increased vigilance from the FDA against firms offering coronavirus antibody tests that it believes could harm consumers.
Ortho offers a total antibody test detecting all COVID-19 related antibodies and an IgG antibody test, both of which received Emergency Use Authorization in April.
The novel blood test uses vibrational spectroscopy and metabolomic analysis to differentiate patients with fibromyalgia from those with other autoimmune disorders.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
In April the firm received notice that it wasn't in compliance because its common stock didn't maintain a minimum bid price of $1.00 for 30 consecutive business days.
The company is providing DNA/RNA extraction kits, viral RNA isolation platforms, workstations, and kits for detecting nucleic acids from the coronavirus to the lab.
