Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.

Clinisys Inc. has signed a deal to buy laboratory information company Horizon Lab Systems LLC and combine Sunquest Information Systems under the Clinisys brand. The resulting group will be one of the world's largest laboratory informatics organizations. Clinisys and Sunquest share the same parent company – Roper Technologies Inc., which trades on the NYSE stock exchange. The addition of Raleigh, N.C.-based Horizon provides Clinisys with expertise in the public health, environmental, water quality, toxicology and agriculture markets.

Sema4 Holdings Corp. sent a bold message to the market with a definitive agreement to acquire Genedx Inc. from Opko Health Inc. for $623 million. The deal comes as Sema4 winds down its COVID-19 testing by the end of March. The company has been one of the largest testing organizations in Connecticut since its first contract in May 2020, but has lately come under scrutiny because of an investment by Annie Lamont, the governor’s wife.

In a lively discussion at the 40th annual J.P. Morgan Healthcare Conference, panelists from leading diagnostics companies debated the best way to screen for cancer – and whether diagnostic testing does more harm than good in some circumstances. Kevin Conroy, CEO of Exact Sciences Corp., noted that he expected liquid biopsies to have an “enormous impact on making earlier cancer detection a routine part of medical care” with his company currently developing a blood-based test for colon cancer as well as a multicancer test and one for minimal residual disease.

In a speech on Jan. 13, President Joe Biden revealed plans to purchase an additional 500 million at-home COVID-19 tests, bringing the total number the administration expects to provide for free to American households to 1 billion. In addition, Biden said the administration would distribute free “high quality masks.” On Wednesday, the administration said it would provide 5 million rapid COVID-19 tests and 5 million lab-based PCR tests to schools each month to support screening testing and test-to-stay programs.

Point-of-care (POC) diagnostics startup Chronus Health Inc. reeled in $22 million in a series A round led by Tarsadia Investments. The company plans to use the funds to scale its research, engineering and data science teams and hasten product and technology development. Monta Vista Capital, Sosv and Savantus Ventures also participated in the financings, along with an unidentified strategic investor.

Illumina Inc. and Agendia NV are joining forces for a multiyear partnership to develop diagnostic tests for breast cancer. The collaboration will unite lllumina’s Miseq Dx sequencing platform, with Agendia's flagship genomic test, Mammaprint, which identifies a patient’s breast cancer recurrence risk. Illumina has been steadily signing partnerships over the past few years and currently has more than 30 IVD partners and 40 sequencing-based solutions for cancer under development.

The existence of prior art isn’t always readily evident when companies in the device and diagnostic spaces file patent applications with the U.S. Patent and Trademark Office (PTO). As it turns out, literature describing that prior art need not be widely distributed to invalidate a patent as Quest Diagnostics Inc., of Secaucus, N.J., recently discovered, an object lesson for all in the med-tech space that research for prior art must be exhaustive if a patent is to hold up over time.

Freenome Holdings Inc. has landed $290 million from Basel, Switzerland-based Roche Holding AG to advance its multiomics platform for early cancer detection. The multimillion financing deal brings San Francisco-based Freenome’s total funding to more than $1.1 billion, securing its status as a unicorn company. It comes on the heels of a series D raise in December 2021, which netted Freenome $300 million from investors including Perceptive Advisors and RA Capital Management.