Latest Headlines

1. Sera Prognostics Announces Pricing For PreTRM® Test, The Only Broadly Validated Blood Test To Assess Risk Of Preterm Birth 12/2/2021

   Sera Prognostics Inc., The Pregnancy Company® (NASDAQ: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the Centers for Medicare & Medicaid Services (CMS) has set a Medicare payment rate for the existing unique Proprietary Laboratory Analysis (PLA) code, 0247U, for the PreTRM® test, the company's proprietary proteomic blood test for measuring a woman's risk of spontaneous preterm birth to allow more timely intervention.

2. Eurofins Environment Testing Launches PFAS Exposure Self-Collection Blood Test 12/1/2021

   Per- and Polyfluorinated Alkyl Substances (PFAS), such as PFOA and PFOS, known as “forever chemicals”, characteristically resist natural breakdown in the environment and human bodies.

3. ASCP And CLMA Align To Provide Excellence, Education, And Advocacy For Laboratory Professionals 12/1/2021

   Today the American Society for Clinical Pathology (ASCP) and the Clinical Laboratory Management Association (CLMA) announced that CLMA will join the ASCP as a division of ASCP, thus aligning the organizations.

4. Roche Completes Purchase Agreement With Long-Term Partner TIB Molbiol To Expand PCR-Test Portfolio In The Fight Against New Infectious Diseases 12/1/2021

   Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has completed its share purchase agreement to acquire 100 percent of the outstanding shares of TIB Molbiol Group. TIB Molbiol will continue to operate as a subsidiary within the Diagnostics division.

5. FDA Clears SeptiCyte® RAPID - The First One-Hour, Direct-From-Blood Sepsis Test 11/30/2021

   Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced that SeptiCyte® RAPID has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

6. MAKO Medical Prepared To Detect Omicron Variant 11/30/2021

   MAKO Medical Laboratories, a national reference laboratory and leader in COVID-19 testing, today announced preparedness to detect the potential emergence of the Omicron Variant, with significant available capacity for sequencing and PCR testing.

7. Applied DNA Announces Strategy To Address Omicron SARS-CoV-2 Variant, Introduces Linea 2.0 COVID-19 Assay Kit 11/29/2021

   Applied DNA Sciences, Inc. (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, today announced its COVID-19 diagnostic strategy in response to the emergence of Omicron (B.1.1.529), a newly identified SARS-CoV-2 variant of concern.

8. BioReference Laboratories Announces Readiness For COVID-19 Testing If The Omicron COVID-19 Variant Emerges In The U.S. 11/29/2021

   BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), announced COVID-19 testing preparedness for the Omicron Variant. BioReference's PCR diagnostic tests for SARS-CoV-2 COVID-19 are based on recognizing specific RNA target genes that are common to all coronaviruses.

9. Thermo Fisher Scientific Confirms Detection Of SARS-CoV-2 In Samples Containing The Omicron Variant With Its TaqPath COVID-19 Tests 11/29/2021

   Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today confirmed that its polymerase chain reaction (PCR) TaqPath COVID-19 Combo Kit*, and TaqPath COVID-19 CE-IVD RT-PCR Kit*, which test for the presence of SARS-CoV-2, are not impacted by the emerging B.1.1.529, or Omicron variant, enabling accurate test results.

10. QIAGEN And DiaSorin Widen Access To Latent TB Testing In The U.S. With FDA Approval Of QuantiFERON-TB Gold Plus Assay On LIAISON XS 11/29/2021

    QIAGEN and DiaSorin (FTSE MIB: DIA) today announced that the U.S. Food and Drug Administration (FDA) has approved the LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin’s automated LIAISON XS platform.