Diagnostics

The FDA has amended OraSure Technologies Inc's (NASDAQ: OSUR) Emergency Use Authorization (EUA) for its InteliSwab COVID-19 rapid tests to only require one test for symptoms of COVID-19.  Related Link: OraSure Wins $109M Contract To Increase COVID-19 Test Manufacturing...

Becton Dickinson and Co (NYSE: BDX) has partnered with Amazon.com Inc (NASDAQ: AMZN) to begin shipment of a new at-home rapid COVID-19 test that can confirm results using an entirely automated smartphone app. The BD Veritor At-Home COVID-19 Test, which U.S. regulators...

LumiraDx (NASDAQ: LMDX) has received emergency use approval by India's Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test.  The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application....

A World Health Organization-led program for equitable access to COVID-19 vaccines, tests, and treatments aims to secure antiviral drugs for patients with mild symptoms for $10 per course, according to a draft document seen by Reuters. Merck & Co Inc's (NYSE: MRK) experimental...

Quidel Corporation (NASDAQ: QDEL) announced preliminary estimates for its Q3 revenues are expected to rise between 6% and 7% Y/Y on COVID-19 assay sales. Related: Quidel Stock Falls As Q2 Earnings Miss Street Estimates On Lower COVID-19, Influenza Product Sales. For Q3, Quidel...

Caris Life Sciences and ESSA Pharma Inc (NASDAQ: EPIX) have announced a Precision Development program to support ESSA's development of EPI-7386 in metastatic castration-resistant prostate cancer (mCRPC) failing current standard-of-care therapies. Under the terms of the...

Centogene NV (NASDAQ: CNTG) and Twist Bioscience Corporation (NASDAQ: TWST) have signed a contract to develop and commercialize custom assay kits for rare diseases. The financial details of the deal were not disclosed. Related: Twist Bioscience, Boehringer Ingelheim Joins Forces For Antibody...

The White House will invest another $1 billion to boost supplies of COVID-19 at-home tests, CNN reports. Related Link: Employer Demand For Rapid COVID-19 Tests Deepens Shortage In US A White House official said the U.S. will announce a $1 billion investment, which will go toward the...

In recent weeks, an increase in demand for COVID-19 tests from U.S. employers has deepened the shortage of rapid tests and is driving up testing programs costs. What Happened: The rush to stockpile tests comes after the White House said it plans to mandate weekly testing for unvaccinated staff at...

OraSure Technologies Inc (NASDAQ: OSUR) has secured a $109 million contract from the U.S. Department of Defense to build additional manufacturing capacity in the U.S. for InteliSwab COVID-19 rapid tests. Related: OraSure Secures $13.6M BARDA Funding For InteliSwab COVID-19 Test...

The FDA has granted Emergency Use Authorization (EUA) to Laboratory Corp of America Holdings's (NYSE: LH) combined home collection kit to detect COVID-19 and influenza A/B simultaneously in individuals as young as 2 years of age.  The kit will be available at no upfront cost to...

Biomerica Inc (NASDAQ: BMRA) has entered into a Supplier Agreement with Walmart Inc (NYSE: WMT) to sell its EZ Detect colorectal disease screening test within the Walmart retail system.  Beginning this week, Walmart has started selling the product through its online...

Qiagen NV (NYSE: QGEN) won a U.S. government contract to increase the production capacity for consumables used on its NeuMoDx 96 and 288 integrated PCR testing systems. Related Link: Qiagen's COVID-19 Antigen Test Gets FDA Emergency Use Approval Qiagen was awarded a $3.4...

The FDA has issued a letter to establish additional conditions of Emergency Use Authorizations (EUAs) manufacturers of COVID-19 tests. The agency has asked COVID-19 test manufacturers to assess the impact of SARS-CoV-2 viral mutations on the performance of their products. Related:...

The Biomedical Advanced Research Development Authority (BARDA) will provide up to $13.6 million in funding to OraSure Technologies Inc (NASDAQ: OSUR). The fund is related to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for OraSure's...