Tempus Labs, Inc. receives its first
premarket approval from the FDA for xT CDx
United
States: Tempus
Labs, Inc. on Monday, 1st May 2023 announced that it has received
its first Premarket Approval (PMA) for its companion diagnostic test, xT CDx. xT
CDx is a 648-gene tissue-based next generation sequencing based in-vitro
diagnostic device which is used for molecular profiling of all solid malignant
tumors and companion diagnostic for patients with colorectal cancer. xT CDx is
intended to be used for detecting substitutions, insertions and deletions in
648 genes. It detects substitution of both single nucleotide variants and multi
nucleotide variants. xT CDx uses formalin-fixed paraffin embedded (FFPE) tumor
tissue specimens, and DNA isolated from matched normal blood or saliva
specimens, from previously diagnosed cancer patients with solid malignant
neoplasms to detect microsatellite instability (MSI) status.
xT CDx can also be used to
identify patients who may benefit from treatment with the targeted therapies
for colorectal cancer by detecting RAS genes in tumor samples of colorectal
cancer patients. xT CDx can detect biomarkers such as KRAS wild-type colorectal
cancer (absence of mutations in codons 12 or 13) in patients who could benefit
from receiving cetuximab (Erbitux). It can also serve as a companion diagnostic
in patients who could receive panitumumab (Vectibix) by detecting biomarkers
like KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS
wild-type (absence of mutations in exons 2, 3, or 4). If xT CDx does not detect
a mutation (presumed to be RAS mutation-negative), then panitumumab or
cetuximab may be appropriate treatment options.
According to the Founder
& CEO of Tempus, Inc.,
“This is a significant milestone for Tempus as we continue to establish a
regulatory pathway for our platform, which offers solutions to advance both
clinical care and support cutting-edge research,” said Eric Lefkofsky, Founder
and CEO of Tempus. “We designed xT CDx to be a smart test that can empower
physicians to provide personalized care for their patients and support
researchers in developing better therapeutics.”
According to TechSci Research, product launches have
always been a key strategy followed by different companies operating in a
particular industry to maintain a strong market positioning and hold. The
healthcare industry has witnessed a lot of innovative product launches in
recent years and is still witnessing a lot. Over the years the scenario has
changed from established players bringing new products or extending their
existing portfolios to small and medium size companies and startups bringing
novel products focusing on a particular disease area or application. A product
launch provides an opportunity to generate buzz and increase awareness about
the company and its offerings. This can lead to greater visibility within the
healthcare industry, attracting attention from potential customers, investors,
and partners. Also, novel product launches help companies to differentiate
themselves from competitors. By offering innovative solutions or addressing
unmet needs in the market, they can gain a competitive edge and attract
customers who are looking for novel or superior alternatives.
The approval of xT CDx has
made Tempus Labs, Inc., a technology company, advancing precision medicine
through the practical application of artificial intelligence in healthcare a
one-stop-shop for precision medicine solutions. Tempus Labs, Inc. has one of
the world’s largest libraries of multimodal data, this product launch will help
the company in attracting collaborators who can leverage the company’s collection
of intelligent diagnostics, clinical trial matching capabilities, and its
ever-growing library of multimodal data to support therapeutic innovation. The
company is also planning to apply xT CDx to support companion diagnostics
claims in collaborations with biopharma companies. Hence, it can be witnessed that
the company is collaborating with different biopharma companies and using xT
CDx in diagnosis and developing therapeutic solutions for different diseases in
the years to come.