Big lab test company Launches Companion Diagnostic for Big pharma’s Newly-approved Lung Cancer Therapy

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https://www.bloomberg.com/press-rel...or-amgen-s-newly-approved-lung-cancer-therapy

Business

Labcorp Launches Companion Diagnostic for Amgen’s Newly-approved Lung Cancer Therapy​

2 July 2021, 5:03 AM SGT
Labcorp Launches Companion Diagnostic for Amgen’s Newly-approved Lung Cancer
Therapy

Test Expands Labcorp’s Leadership In Bringing Testing Solutions for New
Precision Medicines Used to Treat Patients With Lung Cancer

Business Wire

BURLINGTON, N.C. -- July 1, 2021

Labcorp^® (NYSE: LH), a leading global life sciences company, today announced
the availability of therascreen^®KRAS PCR Mutation Analysis, a companion
diagnostic to identify patients with non-small cell lung cancer (NSCLC) who
are eligible for treatment with LUMAKRAS™ (sotorasib), a new treatment option
developed by Amgen.

 

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Labcorp’s oncology platform brings together the company’s leadership in
diagnostic testing with its comprehensive drug development services, helping
to pioneer scientific breakthroughs like the KRAS companion diagnostic to
identify patients eligible for cutting-edge targeted therapies.

“Every day, cancer patients across the country anxiously await test results
that directly impact treatment decisions. Through our collaboration with
QIAGEN and participation in their Day-One Lab Readiness Program, Labcorp is
committed to ensuring critical biomarker testing for KRAS is immediately
accessible to physicians to ensure every patient who may benefit from
sotorasib is appropriately identified and treated,” said Prasanth Reddy, M.D.,
MPH, senior vice president and oncology head at Labcorp, and a triple-board
certified hematology and oncology physician. “Labcorp is proud to be one of
the first labs to make the therascreenKRAS test available, in addition to the
many other diagnostic tests in our testing portfolio, including companion
diagnostics that have been made available soon after FDA approval for breast,
lung, colorectal, bladder and other cancers.”

 

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The therapy and this indicated use of the test as a companion diagnostic
received approval from the U.S. Food and Drug Administration (FDA) in late May
2021. The therascreen ^ KRAS PCR Mutation Analysis is now available for
ordering from Labcorp to determine if patients carry a specific mutation in
the KRAS gene.

QIAGEN (NYSE: QGEN, Frankfurt Stock Exchange: QIA) developed the assay, and
Labcorp applied its scientific validation process to be able to offer the
assay through its CAP accredited, CLIA-certified specialty labs. Using the
lung biopsy specimen, the assay identifies whether a patient with NSCLC has a
specific mutation in the KRAS gene and is eligible for treatment with
LUMAKRAS™ (sotorasib) which was developed by Amgen (NASDAQ: AMGN). This is the
first FDA-approved biomarker-driven, targeted therapy for the treatment of
adults with NSCLC whose tumors have a specific type of genetic mutation called
KRAS G12C and who have received at least one prior systemic therapy. KRAS
mutations have been found to enable cells in certain cancers to grow and
spread more easily.

According to the American Cancer Society, in 2020, 10-12% of the 228,000
people diagnosed with lung cancer carry the G12C KRAS mutation. Lung cancer is
still one of the most common cancers worldwide. Approximately 84% of lung
cancers are NSCLC.

“We have a longstanding relationship with Labcorp and are delighted to
collaborate with them again to bring this new companion diagnostic indication
to NSCLC patients,” said Jonathan Arnold, vice president, Oncology and
Partnering for Precision Diagnostics at QIAGEN. “The expanded indication on
our QIAGEN therascreen KRAS test will provide clinically relevant information
to aid physicians in identifying patients eligible for a new class of
treatment in NSCLC.”

During the last 25 years, Labcorp has played a significant role in launching
hallmark testing options for the treatment of cancer. The company remains
committed to further developing companion diagnostics and precision medicines.
This new offering adds to its growing portfolio of tests that specialize in
more personalized care, leading to more specific treatment choices. In
addition to single marker tests, Labcorp offers full panels of testing powered
by advanced next generation-sequencing (NGS) technology for complete profiling
of a patient’s unique tumor, including mutations in KRAS.

For more information about Labcorp’s full menu of companion and complementary
diagnostic tests, visit oncology.labcorp.com.

LUMAKRAS™ is a trademark of Amgen, Inc.

therascreen^® is a registered trademark of QIAGEN.

 

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About Labcorp

Labcorp is a leading global life sciences company that provides vital
information to help doctors, hospitals, pharmaceutical companies, researchers,
and patients make clear and confident decisions. Through our unparalleled
diagnostics and drug development capabilities, we provide insights and
accelerate innovations to improve health and improve lives. With more than
70,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE:
LH) reported revenue of $14.0 billion in FY2020. Learn more about us at
www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.

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https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics

Companion Diagnostics​

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A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.
Companion diagnostics can:

• identify patients who are most likely to benefit from a particular therapeutic product;
• identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; or
• monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

If the diagnostic test is inaccurate, then the treatment decision based on that test may not be optimal.
On July 31, 2014 the FDA issued "Guidance for Industry: In Vitro Companion Diagnostic Devices," to help companies identify the need for companion diagnostics at an earlier stage in the drug development process and to plan for co-development of the drug and companion diagnostic test. The ultimate goal of the guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients living with serious and life-threatening diseases.