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OPKO Health (OPK) Receives FDA Nod for the 4Kscore Test
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OPKO Health, Inc. (OPK - Free Report) recently received the FDA approval for its 4Kscore Test. Presently, this test is available at BioReference Laboratories — an OPKO Health company — via its specialty oncology and urology division, GenPath.
The 4Kscore test has been given the nod for use in men, age 45 and above, who have not had a prostate biopsy previously or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam (DRE). The test offers a numerical value to evaluate the presence of aggressive prostate cancer prior to making a decision to perform a prostate biopsy.
Per management, the 4Kscore Test has been available as a Laboratory Developed Test (LDT) since 2014. The FDA approval will further highlight its importance as a crucial tool in the diagnostic paradigm for prostate cancer.
The latest approval is likely to provide a boost to OPKO Health’s Diagnostics business.
More on the News
The 4Kscore Test is an in vitro serum or plasma test that brings together four immunoassays — Roche Elecsys total PSA (prostate-specific antigen), Roche Elecsys free PSA, intact PSA and human kallikrein 2 — into a single numerical score that also incorporates a patient’s age, prior biopsy status and digital rectal exam results.
The approval came based on data from two prospective clinical studies carried out in the United States.
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The 4Kscore Test has been utilized by more than 7,700 health care providers, which included about 4,200 urologists. Since its launch as an LDT in 2014, more than 300,000 tests have been performed.
The test has been included in the National Comprehensive Cancer Network Guidelines (NCCN) since 2015. It has also been part of the European Association of Urology Prostate Cancer Guidelines since 2016. OPKO Health has provided this test in the United States, Europe and elsewhere.
Market Prospects
Per a report by Allied Market Research, the global prostate cancer treatment market was worth $6.89 million in 2018 and is expected to reach $9.90 billion by 2026, witnessing a CAGR of 4.6% from 2019 to 2026. Hence, this approval comes at an opportune time for OPKO Health.
Recent Developments
In November, BioReference Laboratories made an announcement regarding its COVID-19 testing preparedness in the face of the Omicron variant threat. BioReference’s PCR diagnostic tests for SARS-CoV-2 COVID-19 are based on identifying specific RNA target genes, which are common to all coronaviruses.
In September, OPKO Health announced that the review period for the biologics license application (“BLA”) for somatrogon has received a further extension of three months from the FDA. A decision from the FDA is now expected in January 2022.
In the same month, the company formed a joint venture (JV) with LeaderMed Health Group Limited to develop, manufacture and commercialize two of OPKO Health’s clinical-stage, long-acting drug products in Greater China and eight more Asian regions.
Price Performance
Shares of this Zacks Rank #3 (Hold) company have lost 14.3% in the past year against the industry’s growth of 7.4%.
Stocks to Consider
Some better-ranked stocks in the broader medical space include Thermo Fisher Scientific Inc. (TMO - Free Report) , McKesson Corporation (MCK - Free Report) and AmerisourceBergen Corporation .
Thermo Fisher’s long-term earnings growth rate is estimated at 14%. The company’s earnings yield of 3.7% compares favorably with the industry’s (3.6%).
McKesson beat earnings estimates in each of the trailing four quarters, the average surprise being 19.9%. The company currently carries a Zacks Rank #2.
McKesson’s long-term earnings growth rate is estimated at 8.9%. The company’s earnings yield of 9.9% compares favorably with the industry’s 3.2%.
AmerisourceBergen surpassed earnings estimates in each of the trailing four quarters, the average surprise being 5.5%. The company currently carries a Zacks Rank of 2.
AmerisourceBergen’s long-term earnings growth rate is estimated at 11.3%. The company’s earnings yield of 8.9% compares favorably with the industry’s 3.3%.
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OPKO Health (OPK) Receives FDA Nod for the 4Kscore Test
OPKO Health, Inc. (OPK - Free Report) recently received the FDA approval for its 4Kscore Test. Presently, this test is available at BioReference Laboratories — an OPKO Health company — via its specialty oncology and urology division, GenPath.
The 4Kscore test has been given the nod for use in men, age 45 and above, who have not had a prostate biopsy previously or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam (DRE). The test offers a numerical value to evaluate the presence of aggressive prostate cancer prior to making a decision to perform a prostate biopsy.
Per management, the 4Kscore Test has been available as a Laboratory Developed Test (LDT) since 2014. The FDA approval will further highlight its importance as a crucial tool in the diagnostic paradigm for prostate cancer.
The latest approval is likely to provide a boost to OPKO Health’s Diagnostics business.
More on the News
The 4Kscore Test is an in vitro serum or plasma test that brings together four immunoassays — Roche Elecsys total PSA (prostate-specific antigen), Roche Elecsys free PSA, intact PSA and human kallikrein 2 — into a single numerical score that also incorporates a patient’s age, prior biopsy status and digital rectal exam results.
The approval came based on data from two prospective clinical studies carried out in the United States.
The 4Kscore Test has been utilized by more than 7,700 health care providers, which included about 4,200 urologists. Since its launch as an LDT in 2014, more than 300,000 tests have been performed.
The test has been included in the National Comprehensive Cancer Network Guidelines (NCCN) since 2015. It has also been part of the European Association of Urology Prostate Cancer Guidelines since 2016. OPKO Health has provided this test in the United States, Europe and elsewhere.
Market Prospects
Per a report by Allied Market Research, the global prostate cancer treatment market was worth $6.89 million in 2018 and is expected to reach $9.90 billion by 2026, witnessing a CAGR of 4.6% from 2019 to 2026. Hence, this approval comes at an opportune time for OPKO Health.
Recent Developments
In November, BioReference Laboratories made an announcement regarding its COVID-19 testing preparedness in the face of the Omicron variant threat. BioReference’s PCR diagnostic tests for SARS-CoV-2 COVID-19 are based on identifying specific RNA target genes, which are common to all coronaviruses.
In September, OPKO Health announced that the review period for the biologics license application (“BLA”) for somatrogon has received a further extension of three months from the FDA. A decision from the FDA is now expected in January 2022.
In the same month, the company formed a joint venture (JV) with LeaderMed Health Group Limited to develop, manufacture and commercialize two of OPKO Health’s clinical-stage, long-acting drug products in Greater China and eight more Asian regions.
Price Performance
Shares of this Zacks Rank #3 (Hold) company have lost 14.3% in the past year against the industry’s growth of 7.4%.
Stocks to Consider
Some better-ranked stocks in the broader medical space include Thermo Fisher Scientific Inc. (TMO - Free Report) , McKesson Corporation (MCK - Free Report) and AmerisourceBergen Corporation .
Thermo Fisher surpassed earnings estimates in each of the trailing four quarters, the average surprise being 9.02%. The company currently carries a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Thermo Fisher’s long-term earnings growth rate is estimated at 14%. The company’s earnings yield of 3.7% compares favorably with the industry’s (3.6%).
McKesson beat earnings estimates in each of the trailing four quarters, the average surprise being 19.9%. The company currently carries a Zacks Rank #2.
McKesson’s long-term earnings growth rate is estimated at 8.9%. The company’s earnings yield of 9.9% compares favorably with the industry’s 3.2%.
AmerisourceBergen surpassed earnings estimates in each of the trailing four quarters, the average surprise being 5.5%. The company currently carries a Zacks Rank of 2.
AmerisourceBergen’s long-term earnings growth rate is estimated at 11.3%. The company’s earnings yield of 8.9% compares favorably with the industry’s 3.3%.