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Precipio prices $2M stock offering and concurrent private placement
The specialty cancer diagnostics company intends to use the net proceeds for working capital and general corporate purposes.
June 8, 2023
GrapheneDx, General Graphene, Sapphiros partner to develop graphene IVD biosensors
GrapheneDx's first tests to be released under the collaboration will be for the diagnosis of sexually transmitted infections, including chlamydia and gonorrhea, using a urine sample.
June 7, 2023
FDA clears DeepX Diagnostics digital dermatoscope to screen for suspected skin cancer lesions
The device has conducted more than 180 thousand assessments in pharmacies and primary care clinics in Europe; DeepX is poised to enter the U.S. market.
June 6, 2023
Seegene obtains IVDR certification for 30 diagnostic assays
The newly certified assays include eight for gastrointestinal infections, seven for women's diseases, five for respiratory diseases, four for tuberculosis, three for meningitis, two for human papillomavirus (HPV), and one for drug resistance.
June 1, 2023
Advocacy groups in letter urge FDA to develop regulations for lab-developed tests
The FDA should use its authority to develop laboratory-developed test regulations if Congress does not pass legislation requiring it, said the Center for Science in the Public Interest and other organizations.
June 1, 2023
Week in Review: Labcorp liquid biopsy | Deep sequencing | Heart disease markers and diabetes
Labcorp has launched a liquid biopsy test to enable targeted therapy selection for patients with advanced or metastatic solid tumors.
June 1, 2023
Nucleai, Adlai Nortye collaborate on biomarkers for clinical trials
The partnership will combine Nucleai's expertise in extracting and analyzing the quantitative spatial features of pathology images and Adlai Nortye's expertise in drug development and immunotherapy.
May 31, 2023
Georgia doctor, clinics to pay $625K to resolve False Claims Act allegations
The defendants allegedly submitted improper claims to Medicare and Tricare insurance programs for evaluation and management services as well as medically unnecessary urine drug screening tests.
May 31, 2023
Romanian IVD market worth watching, rose to $464M in 2022
The Eastern European country's IVD market will grow 25% faster than that of the United States, according to Kalorama Information in its latest 30-Country IVD Market Atlas.
May 31, 2023
FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
Paxlovid is the fourth drug — and first antiviral pill — approved by the FDA to treat COVID-19 in adults.
May 25, 2023
Agilent Technologies fiscal Q2 revenues rise 7%; firm trims full-year estimates
Diagnostics and Genomics Group revenues were $362 million, up 1% year-over-year compared to $358 million.
May 24, 2023
Industry organizations urge Congress to protect access to laboratory tests
In a letter to Congress, provider organizations make the case that without congressional action, Medicare reimbursement cuts could jeopardize access to many clinical laboratory tests.
May 22, 2023
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