Optellum is engaged in proffering AI decision support for the early diagnosis and optimal lung cancer treatment, while GE Healthcare is a major player in medical imaging solutions.
The Virtual Nodule Clinic, the AI-powered clinical decision support software developed by Optellum, enables recognition and score of the probability of malignancy in a lung nodule, which is considered vital in determining the requirement for a biopsy.
The AI-assisted diagnosis software is already secured and approved by the US Food and Drug Administration (FDA) for early-stage lung cancer.
According to Optellum, the software holds the capability to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules, allowing to make optimal clinical decisions.
GE plans to work with Optellum to integrate the software platform with AI solutions powered by GE Healthcare’s Edison platform as part of the partnership.
FDA places a clinical hold on Ocugen’s Phase III Covid-19 vaccine trial
The US Food and Drug Administration (FDA) has placed a clinical hold on Ocugen’s Investigational New Drug application (IND) to commence a Phase III clinical trial of its Covid-19 vaccine candidate, BBV152.
It is called Covaxin outside the US; Bharat Biotech developed the vaccine in partnership with the Indian Council of Medical Research – National Institute of Virology. Bharat Biotech and Ocugen entered a binding letter of intent in December 2020 to co-develop the vaccine for the US market.
Made using a Vero cell manufacturing platform, Covaxin is a purified and inactivated vaccine. This October, Ocugen filed an IND application with the FDA to conduct the trial, which planned to assess the safety and tolerability of the vaccine in the US participants.
Ocugen noted that the FDA plans to detect the peculiar deficiencies that led to the clinical hold of the trial and data on how to rectify them. The company expected to receive official written communication from the FDA that includes further data and plans to cooperate with the agency to answer their queries soon. Presently authorised for emergency use in 17 countries, the vaccine obtained World Health Organization (WHO) emergency use listing in November.
Blueprint buys preclinical biotech for USD 250 Million
J&J’s Rybrevant scored the first approval back in May for a small group of lung cancer patients with a rare EGFR mutation. Despite various biopharma companies angling for a piece of that market, Blueprint Medicines is betting nearly USD 500 million on a candidate it contemplates will stand out.
Blueprint is putting down USD 250 million in cash and another USD 215 million in biobucks for Lengo Therapeutics and its preclinical non-small cell lung cancer program LNG-451. Though it has not been tested in humans, Blueprint says the candidate was highly brain-penetrant in preclinical trials and has the potential to inhibit all common EGFR exon 20 insertion variants — which are found in just 2% to 3% of NSCLC patients.
The new candidate will mark Blueprint’s third program in the works for EGFR mutations, the second most common driver of lung cancer. CEO Jeff Albers plans on swiftly closing the deal and filing an IND by the end of the year.
Albers and Haviland touted impressive preclinical data. However, they won’t see those numbers until next year, and some investors were wary of whether LNG-451 could stand out among the masses.
Therapixel receives FDA approval for AI-based breast cancer screening tool
France-based Therapixel has received the US Food and Drug Administration (FDA) approval for MammoScreen, its AI-powered breast cancer screening software. It is the second 510(k) approval from the FDA and expands its Mammoscreen to Digital Breast Tomosynthesis (3D Mammography) as per the medical technology firm. MammoScreen is a software that helps radiologists improve their performance in interpreting screening 2D and 3D mammograms.
The software automatically recognises and characterises suspicious soft tissue lesions and calcifications in mammography and tomosynthesis images. It also evaluates mammography and tomosynthesis images to seek any malignancy. The tool summarises the results through MammoScreen Score, which characterises each lesion scored on a scale of 1-10, with 1 being least likely to reveal malignancy.
With the FDA approval, the Mammoscreen can be immediately commercialised across the US mammography market, said Therapixel. The FDA approval was based on the results from a multi-reader study conducted this year.
In the study, the AI-based software improved readers’ performance in screening for lesions, along with significant time saving, compared to radiologists alone. According to the company, MammoScreen covers both the gold standard 2D mammography and the advanced 3D tomosynthesis modalities. The tool received the CE mark approval in January this year.
